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Lymphoma, Non-HodgkinPhase 2TRANSCEND FLNCT04245839

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

A Phase 2 study testing Fludarabine, Cyclophosphamide and JCAR017 in people with Lymphoma, Non-Hodgkin, run by Celgene at 49 sites in 10 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 global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Fludarabine, Cyclophosphamide and JCAR017
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
49 sitesin 10 countries
Study dates
14 Jul 2020to 30 Sep 2031
Phase
Phase 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

  • Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
  • Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
  • Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
  • Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Adequate vascular access for leukapheresis procedure

Who cannot join

  • Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
  • WHO subclassification of duodenal-type FL
  • Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
  • History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
  • Prior CAR T-cell or other genetically-modified cell therapy
  • History of or active human immunodeficiency virus (HIV)
Show all 13Show fewer
  • Active hepatitis B or active hepatitis C
  • Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
  • Active autoimmune disease requiring immunosuppressive therapy
  • Presence of acute or chronic graft-versus-host=disease
  • History of significant cardiovascular disease
  • History or presence of clinically relevant central nervous system pathology
  • Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

Trial locations and contacts

49 sites in 10 countries.

49 sites in 10 countries

United States23 sites

  • Local Institution - 107

    Aurora, Colorado, 80045

  • Local Institution - 102

    Baltimore, Maryland, 21201

  • Local Institution - 100

    Boston, Massachusetts, 02114

  • Local Institution - 101

    Boston, Massachusetts, 02215

  • Local Institution - 110

    Charlotte, North Carolina, 28204

  • Local Institution - 115

    Charlottesville, Virginia, 22903

  • Local Institution - 103

    Chicago, Illinois, 60611

  • Local Institution - 112

    Cleveland, Ohio, 44195

  • Local Institution - 121

    Dallas, Texas, 75230-2510

  • Local Institution - 127

    Detroit, Michigan, 48201

  • Local Institution - 104

    Houston, Texas, 77030

  • Local Institution - 119

    Houston, Texas, 77030

  • Local Institution - 122

    Iowa City, Iowa, 52242

  • Local Institution - 123

    Morristown, New Jersey, 07960

  • Local Institution - 105

    New Haven, Connecticut, 06520

  • Local Institution - 116

    New York, New York, 10021

  • Local Institution - 109

    Niles, Illinois, 60714

  • Local Institution - 117

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 114

    Portland, Oregon, 97213

  • Local Institution - 111

    Santa Monica, California, 90095

  • Local Institution - 108

    Seattle, Washington, 98109

  • Local Institution - 113

    Sioux Falls, South Dakota, 57105

  • Local Institution - 124

    Wichita, Kansas, 67124

Other trials in United States

France6 sites

  • Local Institution - 252

    Lille, 59037

  • Local Institution - 251

    Montpellier, 34295

  • Local Institution - 255

    Paris, 75475

  • Local Institution - 250

    Pierre-Bénite, 69495

  • Local Institution - 253

    Rennes, 35023

  • Local Institution - 254

    Toulouse, 31100

Other trials in France

Germany5 sites

  • Local Institution - 501

    Cologne, 50937

  • Local Institution - 503

    Karlsruhe, 76135

  • Local Institution - 502

    Munich, 81377

  • Local Institution - 504

    Regensburg, Bavaria, 93053

  • Local Institution - 500

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Japan4 sites

  • Local Institution - 550

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 552

    Fukuoka, 812-8582

  • Local Institution - 551

    Minato-ku, Tokyo, 105-8470

  • Local Institution - 553

    Sapporo, Hokkaido, 0608648

Other trials in Japan

Spain3 sites

  • Local Institution - 353

    Madrid, 28007

  • Local Institution - 350

    Salamanca, 37007

  • Local Institution - 351

    Seville, 41013

Other trials in Spain

Canada2 sites

  • Local Institution - 151

    Montreal, Quebec, H1T 2M4

  • Local Institution - 150

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy2 sites

  • Local Institution - 300

    Bergamo, 24127

  • Local Institution - 301

    Naples, 80131

Other trials in Italy

United Kingdom2 sites

  • Local Institution - 200

    London, NW1 2PG

  • Local Institution - 201

    Manchester, M20 4BX

Other trials in United Kingdom

Austria1 site

  • Local Institution - 450

    Vienna, 1090

Other trials in Austria

Sweden1 site

  • Local Institution - 600

    Stockholm, 14186

Other trials in Sweden

About this study

Official title: A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

Read more

This study is divided into three periods:

  • Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
  • Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
  • Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.
Being tested
Fludarabine, Cyclophosphamide, JCAR017
Keywords
B-cell Non-Hodgkin Lymphoma (NHL), JCAR017, Relapsed or Refractory, Follicular Lymphoma, Marginal Zone Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Recurrence, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

What participants receive

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

Study groups in NCT04245839
Study groupRoleWhat they receive
Administration of JCAR017Experimental* Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents. * JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: JCAR017

What is being measured

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

  1. Overall Response Rate (ORR)

    Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"

    Measured: Up to 60 months

Secondary outcomes (11)

  1. Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"

    Is defined as the percentage of subjects achieving a CR at any time up to 60 months after JCAR017 treatment

    Measured: Up to 60 months

  2. Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"

    is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 60 months after JCAR017 treatment

    Measured: Up to 60 months

  3. Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"

    is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment

    Measured: Up to 60 months

  4. Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"

    is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment

    Measured: Up to 60 months

  5. Overall Survival (OS)

    is defined as the time from start of JCAR017 to time of death due to any cause up to 60 months after JCAR017 treatment

    Measured: Up to 60 months

  6. Adverse Events (AEs)

    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

    Measured: Up to 60 months

  7. Pharmacokinetics - Cmax

    Maximum concentration

    Measured: Up to 60 months

  8. Pharmacokinetics - Tmax

    Time to maximum concentration

    Measured: Up to 60 months

  9. Pharmacokinetics - AUC

    Area under the curve

    Measured: Up to 60 months

  10. European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)

    is questionnaire that will be used as a measure of health-related quality of life.

    The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.

    Measured: Up to 24 months

  11. Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)

    is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. High scores indicate lower symptom burden.

    Measured: Up to 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 posted29 Jan 2020
  2. Study start14 Jul 2020
  3. Primary completion30 Sep 2031 (estimated)
  4. Study completion30 Sep 2031 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04245839
Sponsor's protocol ID
JCAR017-FOL-001
Other IDs
U1111-1244-9768, 2024-510966-18
Acronym
TRANSCEND FL
Status last verified
Nov 2025
First submitted
27 Jan 2020
Last updated
5 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Publications

  • Makita S, Goto H, Izutsu K, Baba Y, Bar M, Strocchia M, Ghodke P, Nishii R, Teshima T. Efficacy and safety of lisocabtagene maraleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: 31-month follow-up of the phase 2 TRANSCEND FL study. Int J Clin Oncol. 2026 Oct 14. doi: 10.1007/s10147-026-03199-5. Online ahead of print.

    PubMed 42875607

  • Ahmed S, Martin Garcia-Sancho A, Reguera-Ortega JL, Cartron G, Rapoport AP, Izutsu K, Ghesquieres H, Goto H, Palomba ML, Abramson JS, Borchmann P, Jaeger U, Kamdar M, Dreyling M, Subklewe M, Dahiya S, Nastoupil LJ, Bar M, Strocchia M, Raggi M, Moro Bueno L, Papuga J, Colicino S, Morschhauser F. Durable efficacy and manageable long-term safety of lisocabtagene maraleucel in 3L+ FL: 3-year update from TRANSCEND FL. Blood. 2026 Jul 1:blood.2026034327. doi: 10.1182/blood.2026034327. Online ahead of print.

    PubMed 42462111

  • Palomba ML, Schuster SJ, Karmali R, Skarbnik AP, Abramson JS, Ardeshna K, Borchmann P, Hill BT, Garcia-Sancho AM, Marcacci G, Rapoport AP, Cartron G, Fleury I, Izutsu K, Kamdar M, Mielke S, Barbui AM, Ortega JLR, Nastoupil LJ, Ahmed S, Bar M, Diaz L, Furustrand U, Diab V, Vedal M, Avilion A, Kumar J, Nishii R, Colicino S, Morschhauser F. Lisocabtagene maraleucel in patients with relapsed or refractory marginal zone lymphoma (TRANSCEND FL): primary analysis results from the global, multicohort, single-arm, phase 2 study. Lancet. 2026 Mar 7;407(10532):963-975. doi: 10.1016/S0140-6736(25)02435-3. Epub 2026 Feb 12.

    PubMed 41692020

  • Morschhauser F, Dahiya S, Palomba ML, Martin Garcia-Sancho A, Reguera Ortega JL, Kuruvilla J, Jager U, Cartron G, Izutsu K, Dreyling M, Kahl B, Ghesquieres H, Ardeshna K, Goto H, Barbui AM, Abramson JS, Borchmann P, Fleury I, Mielke S, Skarbnik A, de Vos S, Kamdar M, Karmali R, Viardot A, Farazi T, Fasan O, Lymp J, Vedal M, Nishii R, Avilion A, Papuga J, Kumar J, Nastoupil LJ. Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study. Nat Med. 2024 Aug;30(8):2199-2207. doi: 10.1038/s41591-024-02986-9. Epub 2024 Jun 3.

    PubMed 38830991

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine, Cyclophosphamide and JCAR017 in people with Lymphoma, Non-Hodgkin, run by Celgene at 49 sites in 10 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 7 inclusion and 13 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 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, France, Germany, Japan, Spain and 5 more countries. 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 phase mean?

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?

Overall Response Rate (ORR) (time frame: Up to 60 months). 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 NCT04245839, 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 5 Nov 2025.

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