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AzTrials

Leukemia, Lymphocytic, Chronic, B-CellPhase 1/2NCT03331198

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

A Phase 1/2 study testing JCAR017 (lisocabtagene maraleucel), JCAR017 (lisocabtagene maraleucel) + ibrutinib and JCAR017 (lisocabtagene maraleucel) + venetoclax in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Small Lymphocytic, run by Juno Therapeutics, a Subsidiary of Celgene at 84 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JCAR017 (lisocabtagene maraleucel), JCAR017 (lisocabtagene maraleucel) + ibrutinib and JCAR017 (lisocabtagene maraleucel) + venetoclax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
84 sitesin 2 countries
Study dates
27 Nov 2017to 26 Nov 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of:
  • CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or
  • SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)
  • Subjects (other than those in the ibrutinib + JCAR017 combination therapy and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.
  • Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:
  • Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
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  • Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
  • DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i.
  • Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:
  • be receiving ibrutinib and progressing at the time of study enrollment
  • be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a
  • have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
  • have previously received ibrutinib and have no contraindications to restarting ibrutinib
  • Eastern Cooperative Oncology Group performance status of ≤ 1
  • Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy
  • Adequate organ function, defined as:
  • Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance > 30 mL/min
  • Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
  • Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air
  • Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility
  • Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
  • If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
  • Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax
  • Subjects in venetoclax + JCAR017 combination cohort must:
  • have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
  • be venetoclax naive (required for dose expansion) or
  • if prior venetoclax (only for dose escalation)
  • have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation
  • subjects in the venetoclax + JCAR017 combination must have hemoglobin >=9 g/dL, absolute neutrophil count >=500mm3 and platelets>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
  • must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry

Who cannot join

  • Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
  • History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
  • Subjects with Richter's transformation
  • Prior treatment with any gene therapy product
  • Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
  • Systemic fungal, bacterial, viral, or other infection that is not controlled
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  • Presence of acute or extensive chronic graft versus host disease (GVHD)
  • History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
  • History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
  • Pregnant or nursing (lactating) women
  • Use of any of the following medications or treatments within the noted time prior to leukapheresis:
  • Alemtuzumab within 6 months prior to leukapheresis
  • Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
  • Cladribine within 3 months prior to leukapheresis
  • Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
  • Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
  • Fludarabine within 4 weeks prior to leukapheresis
  • GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α [TNFα], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL 6R]) within 4 weeks prior to leukapheresis
  • Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
  • Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
  • Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
  • Venetoclax within 4 days prior to leukapheresis
  • Idelalisib or duvelisib within 2 days prior to leukapheresis
  • Lenalidomide or covalent and non-covalent BTKi within 1 day prior to leukapheresis
  • Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
  • Progressive vascular tumor invasion, thrombosis, or embolism
  • Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
  • Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
  • Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
  • For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued

Trial locations and contacts

84 sites in 2 countries.

84 sites in 2 countries

United States83 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-5362

  • Local Institution - 0084

    Ann Arbor, Michigan, 48109

  • Local Institution - 0104

    Atlanta, Georgia, 30322

  • Local Institution - 0019

    Atlanta, Georgia, 30342

  • The Blood and Marrow Transplant Group of Georgia (BMTGA)

    Atlanta, Georgia, 30342

  • Local Institution - 0001

    Basking Ridge, New Jersey, 07920

  • Local Institution - 0006

    Birmingham, Alabama, 35294

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Local Institution - 0005

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Local Institution - 0015

    Boston, Massachusetts, 02215

  • Local Institution - 0120

    Charlotte, North Carolina, 28204

  • Local Institution - 0117

    Chattanooga, Tennessee, 37403

  • Local Institution - 0003

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Local Institution - 0016

    Chicago, Illinois, 60637

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University Hospitals Seidman Cancer Center (Case Western)

    Cleveland, Ohio, 44106-5061

  • Local Institution - 0078

    Cleveland, Ohio, 44106

  • Local Institution - 0031

    Columbus, Ohio, 43210

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Local Institution - 0083

    Dallas, Texas, 75390

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Local Institution - 0079

    Dallas, Texas, 75426

  • Local Institution - 0111

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Local Institution - 0062

    Detroit, Michigan, 48201

  • Local Institution - 0109

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • Local Institution - 0007

    Duarte, California, 91010

  • Local Institution - 0030

    Durham, North Carolina, 27705

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Local Institution - 0114

    Edison, New Jersey, 08820

  • Local Institution - 0098

    Eugene, Oregon, 97401

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Local Institution - 0043

    Gilbert, Arizona, 85234

  • Local Institution - 0038

    Hackensack, New Jersey, 07601-2191

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Local Institution - 0002

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Local Institution - 0105

    Indianapolis, Indiana, 46237

  • Local Institution - 0080

    Jacksonville, Florida, 32224

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Local Institution - 0025

    La Jolla, California, 92093

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Local Institution - 0059

    Los Angeles, California, 90095

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Local Institution - 0064

    Louisville, Kentucky, 40202

  • Local Institution - 0055

    Milwaukee, Wisconsin, 53226

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Local Institution - 0106

    Morristown, New Jersey, 07960

  • Local Institution - 0119

    Nashville, Tennessee, 37203

  • Local Institution - 0077

    New Brunswick, New Jersey, 08903

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Local Institution - 0027

    New Orleans, Louisiana, 70112

  • Local Institution - 0035

    New York, New York, 10021

  • Local Institution - 0026

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • Local Institution - 0082

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Health Sciences Center (Stephenson Cancer Center)

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 0008

    Omaha, Nebraska, 68198

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Local Institution - 0088

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0032

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 0029

    Pittsburgh, Pennsylvania, 15232

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0087

    Richmond, Virginia, 23298

  • Local Institution - 0054

    Rochester, Minnesota, 55905

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Local Institution - 0028

    Salt Lake City, Utah, 84112

  • Local Institution - 0010

    San Francisco, California, 94143

  • University of California, San Francisco

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Local Institution - 0018

    Seattle, Washington, 98109

  • Local Institution - 0089

    Stony Brook, New York, 11794-8160

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0085

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0107

    Wichita, Kansas, 67124

  • Local Institution - 0118

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada1 site

  • Local Institution - 0112

    Toronto, Ontario, M5G 2C1

Other trials in Canada

About this study

Official title: An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Being tested
JCAR017 (lisocabtagene maraleucel), JCAR017 (lisocabtagene maraleucel) + ibrutinib, JCAR017 (lisocabtagene maraleucel) + venetoclax
Keywords
TRANSCEND_CLL_004
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JCAR017 (lisocabtagene maraleucel)Biological

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.

  • JCAR017 (lisocabtagene maraleucel) + ibrutinibBiological

    Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.

  • JCAR017 (lisocabtagene maraleucel) + venetoclaxBiological

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.

Study groups in NCT03331198
Study groupRoleWhat they receive
Phase 1 JCAR017 monotherapyExperimentalSubjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)
Receives: Biological: JCAR017 (lisocabtagene maraleucel)
Phase 1 JCAR017 + ibrutinibExperimentalSubjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib
Receives: Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib
Phase 2 JCAR017 monotherapyExperimentalSubjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm
Receives: Biological: JCAR017 (lisocabtagene maraleucel)
Phase 1 JCAR017 + venetoclaxExperimentalSubjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.
Receives: Biological: JCAR017 (lisocabtagene maraleucel) + venetoclax
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)ExperimentalSubjects will receive JCAR017 monotherapy
Receives: Biological: JCAR017 (lisocabtagene maraleucel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1 JCAR017 monotherapy arm: adverse events

    Proportion of subjects experiencing adverse events

    Measured: Up to 48 months post treatment

  2. Phase 1 JCAR017 monotherapy arm: laboratory abnormalities

    Proportion of subjects experiencing laboratory abnormalities

    Measured: Up to 48 months post treatment

  3. Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events

    Proportion of subjects experiencing adverse events

    Measured: Up to 48 months post treatment

  4. Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities

    Proportion of subjects experiencing laboratory abnormalities

    Measured: Up to 48 months post treatment

  5. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm

    Proportion of subjects who have CR after treatment with JCAR017 + ibrutinib using iwCLL 2018 guidelines

    Measured: Through post treatment up to Month 48

  6. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events

    Proportion of subjects experiencing adverse events

    Measured: Up to 48 months post treatment

  7. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities

    Proportion of subjects experiencing laboratory abnormalities

    Measured: Up to 48 months post treatment

  8. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm

    Proportion of subjects who have CR after treatment with JCAR017 + venetoclax using iwCLL 2018 guidelines

    Measured: Through post treatment up to Month 48

  9. Phase 2 JCAR017 monotherapy expansion arm

    Proportion of subjects who have CR after treatment with JCAR017 using iwCLL 2018 guidelines

    Measured: Through post treatment up to Month 48

  10. Phase 2 JCAR017 Double exposed monotherapy expansion arm: overall response rate (ORR)

    ORR defined as the rate of complete response/remission (CR) [including complete response/remission with incomplete marrow recovery (Cri)] plus PR [including nodular partial response (nPR)] based on Independent Review Committee (IRC) assessment using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines

    Measured: Up to approximately 24 months

Secondary outcomes (48)

  1. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: adverse events

    Proportion of subjects experiencing adverse events

    Measured: Up to 48 months post treatment

  2. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: laboratory abnormalities

    Proportion of subjects experiencing laboratory abnormalities

    Measured: Up to 48 months post treatment

  3. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: ORR

    Defined as the rate of CR (including CRi)

    Measured: Up to 48 months post treatment

  4. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood

    Proportion of subjects who achieve MRD CR

    Measured: Up to 48 months post treatment

  5. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD-negative CR rate in peripheral blood

    Proportion of subjects who achieve MRD CR

    Measured: Up to 48 months post treatment

  6. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR)

    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  7. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of complete response (DoCR)

    Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  8. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to response (TTR)

    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR

    Measured: Up to 48 months post treatment

  9. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to complete response (TTCR)

    Defined as the interval from JCAR017 infusion to the first documentation of CR

    Measured: Up to 48 months post treatment

  10. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: PFS

    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  11. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: OS

    Defined as the time from JCAR017 infusion to the date of death due to any cause

    Measured: Up to 48 months post treatment

  12. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: adverse events

    Proportion of subject experiencing adverse events

    Measured: Up to 48 months post treatment

  13. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities

    Proportion of subjects experiencing laboratory abnormalities

    Measured: Up to 48 months post treatment

  14. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: ORR

    Defined as the rate of CR (including CRi)

    Measured: Through post treatment Day 90

  15. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: MRD-negative response rate in peripheral blood

    Proportion of subjects who achieve MRD CR

    Measured: Up to 48 months post treatment

  16. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: MRD-negative CR rate in peripheral blood

    Proportion of subjects who achieve MRD CR

    Measured: Through post treatment Day 90

  17. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of response (DOR)

    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  18. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of complete response (DoCR)

    Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  19. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to response (TTR)

    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR

    Measured: Up to 48 months post treatment

  20. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to complete response (TTCR)

    Defined as the interval from JCAR017 infusion to the first documentation of CR

    Measured: Up to 48 months post treatment

  21. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: PFS

    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  22. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: OS

    Defined as the time from JCAR017 infusion to the date of death due to any cause

    Measured: Up to 48 months post treatment

  23. Phase 2 JCAR017 Monotherapy Expansion Arm: adverse events

    Proportion of subjects experiencing adverse events

    Measured: Up to 48 months post treatment

  24. Phase 2 JCAR017 Monotherapy Expansion Arm: laboratory abnormalities

    Proportion of subjects experiencing laboratory abnormalities

    Measured: Up to 48 months post treatment

  25. Phase 2 JCAR017 Monotherapy Expansion Arm: ORR

    Defined as the rate of CR (including CRi)

    Measured: Up to 48 months post treatment

  26. Phase 2 JCAR017 Monotherapy Expansion Arm: MRD negative response rate in peripheral blood

    Proportion of subjects who achieve MRD CR

    Measured: Up to 48 months post treatment

  27. Phase 2 JCAR017 Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood

    Proportion of subjects who achieve MRD CR

    Measured: Up to 48 months post treatment

  28. Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of response (DOR)

    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  29. Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of complete response (DoCR)

    Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  30. Phase 2 JCAR017 Monotherapy Expansion Arm: Time to response (TTR)

    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR

    Measured: Up to 48 months post treatment

  31. Phase 2 JCAR017 Monotherapy Expansion Arm: Time to complete response (TTCR)

    Defined as the interval from JCAR017 infusion to the first documentation of CR

    Measured: Up to 48 months post treatment

  32. Phase 2 JCAR017 Monotherapy Expansion Arm: PFS

    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause

    Measured: Up to 48 months post treatment

  33. Phase 2 JCAR017 Monotherapy Expansion Arm: OS

    Defined as the time from JCAR017 infusion to the date of death due to any cause

    Measured: Up to 48 months post treatment

  34. Phase 2 JCAR017 Monotherapy Expansion Arm: Health-related quality of life (HRQoL) questionnaire

    Change from baseline in HRQoL assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

    Measured: Up to 48 months post treatment

  35. Phase 2 JCAR017 Monotherapy Expansion Arm: HRQoL questionnaire

    Change from baseline in HRQoL assessed using the EORTC chronic lymphocytic leukemia (CLL)-specific module QLQ-CLL-17

    Measured: Up to 48 months post treatment

  36. Phase 2 JCAR017 Monotherapy Expansion Arm: Health economics and outcomes research (HEOR) questionnaire

    Change from baseline in measurement of health utility values using EuroQol instrument EQ-5D-5L

    Measured: Up to 48 months post treatment

  37. Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire

    Proportion of participants with intensive care unit (ICU) inpatient days

    Measured: Up to 48 months post treatment

  38. Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire

    Proportion of participants with non-ICU inpatient days

    Measured: Up to 48 months post treatment

  39. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: adverse events

    Proportion of subjects experiencing adverse events

    Measured: Up to approximately 24 months

  40. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: laboratory abnormalities

    Proportion of subjects experiencing laboratory abnormalities

    Measured: Up to approximately 24 months

  41. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Duration of response (DOR)

    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause

    Measured: Up to approximately 24 months

  42. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: CR rate

    Defined as the rate of CR (including CRi) based on IRC assessment using iwCLL 2018 guidelines

    Measured: Up to approximately 24 months

  43. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: MRD-negative response rate in peripheral blood

    Proportion of subjects who achieve MRD negative status

    Measured: Up to approximately 24 months

  44. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood

    Proportion of subjects who achieve MRD-negative CR

    Measured: Up to approximately 24 months

  45. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Time to response (TTR)

    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR

    Measured: Up to approximately 24 months

  46. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Time to complete response (TTCR)

    Define as the interval from JCAR017 infusion to the first documentation of CR

    Measured: Up to approximately 24 months

  47. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Progression free survival (PFS)

    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause

    Measured: Up to approximately 24 months

  48. Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Overall Survival (OS)

    Defined as the time from JCAR017 infusion to the date of death due to any cause

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start27 Nov 2017
  3. Primary completion26 Nov 2027 (estimated)
  4. Study completion26 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Phase 1: subjects will be assigned to receive JCAR017, or JCAR017 + ibrutinib, or JCAR017 + venetoclax Phase 2: subjects will be assigned to receive JCAR017 at the recommended dose
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03331198
Sponsor's protocol ID
017004
Other IDs
TRANSCEND-CLL-004
Status last verified
Jul 2026
First submitted
29 Oct 2017
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Publications

  • Wierda WG, Dorritie KA, Gauthier J, Nath R, Kipps TJ, Riedell PA, Eradat HA, Kenderian SS, Kharfan-Dabaja MA, Shah NN, Solomon SR, Stephens DM, Ermann DA, Arnason JE, Deol A, Feldman TA, Andreadis CB, Ghosh M, Ma S, Schuster SJ, Gergis U, Vose JM, Soumerai JD, van Besien K, Tuazon SA, Perna SK, Ou SS, Ananthakrishnan R, Rane N, Papp E, Ansari S, Thompson EG, Okal A, Peiser L, Chen Y, Sengupta S, Ray PR, Wang J, Siddiqi T. Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004. Blood. 2026 Jul 28:blood.2026033565. doi: 10.1182/blood.2026033565. Online ahead of print.

    PubMed 42520199

  • Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, Riedell PA, Shah NN, Nath R, Fakhri B, Stephens DM, Ma S, Feldman T, Solomon SR, Schuster SJ, Perna SK, Tuazon SA, Ou SS, Papp E, Peiser L, Chen Y, Wierda WG. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023 Aug 19;402(10402):641-654. doi: 10.1016/S0140-6736(23)01052-8. Epub 2023 Jun 6.

    PubMed 37295445

  • Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21.

    PubMed 35610089

  • Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895.

    PubMed 34699592

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JCAR017 (lisocabtagene maraleucel), JCAR017 (lisocabtagene maraleucel) + ibrutinib and JCAR017 (lisocabtagene maraleucel) + venetoclax in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Small Lymphocytic, run by Juno Therapeutics, a Subsidiary of Celgene at 84 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 JCAR017 monotherapy arm: adverse events (time frame: Up to 48 months post treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03331198, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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