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Lymphoma, Non-HodgkinPhase 1NCT03448393

CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

A Phase 1 study testing CD19/CD22 CAR T-Cells, Fludarabine and Cyclophosphamide in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, B Cell, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: B-cell leukemias and lymphomas are cancers that are often difficult to treat. The primary objective of this study is to determine the ability to take a patient's own cells (T lymphocytes) and grow them in the laboratory with the cluster of differentiation 19 (CD19/cluster of differentiation 22-chimeric… Read more about this study

Who is it for?
Ages 3 to 39 years
What is being tested?
CD19/CD22 CAR T-Cells, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
26 Mar 2018to 13 Jan 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 3 to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis
  • Participant must have a B cell acute lymphoblastic leukemia (ALL) (inclusive of chronic myeloid leukemia (CML) with ALL transformation) or lymphoma and must have relapsed or refractory disease after at least one standard chemotherapy regimen and one salvage regimen. In view of the principal investigator (PI) and the primary oncologist, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment. Participants who have undergone autologous SCT will be eligible, and participants that have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they have no evidence of graft versus host disease (GVHD) and have been without immunosuppressive agents for at least 30 days. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor.
  • Participants must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis. For those being considered for reinfusions, measurable or evaluable disease is not required at the time of reinfusion.
  • CD22/CD19 expression
  • --CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 90% by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each participant. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples. CD22+ B cell malignancy is required and CD22 expression levels will be documented when available, but a specific level of expression is not an eligibility requirement; it may be documented as positive or negative.
  • Age:
Show all 29Show fewer
  • --Greater than or equal to 3 years of age (and at least 15 kg) and less than or equal to 39 years of age at time of enrollment (greater than or equal to 3 years to less than or equal to 39 years). NOTE: The first participant in each dose cohort must be greater than or equal to 18 years of age.
  • Clinical Performance
  • --Clinical performance status: Participants greater than or equal to 16 years of age: Karnofsky greater than or equal to 50%; Participants < 16 years of age: Lansky scale greater than or equal to 50%. Subjects who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.
  • Participants must have adequate organ and marrow function as defined below:
  • leukocytes greater than or equal to 750/mcL*
  • platelets greater than or equal to 50,000/mcL*
  • total bilirubin less than or equal to 2 X upper limit of normal (ULN) (except in the case of subjects with documented Gilbert's disease > 3x ULN)
  • Aspartate aminotransferase (AST)serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT)serum glutamate pyruvate transaminase (SGPT) less than or equal to 10 X institutional upper limit of normal
  • creatinine less than or equal to the maximum for age listed in the table below
  • Age (Years): less than or equal to 5. Maximum Serum Creatinine (mg/dL): less than or equal to 0.8
  • Age (Years): 6 to less than or equal to 10. Maximum Serum Creatinine (mg/dL): less than or equal to 1.0
  • Age (Years): >10. Maximum Serum Creatinine (mg/dL): less than or equal to 1.2
  • OR
  • creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
  • if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia greater than or equal to Grade 3 if it is due to disease, based on the results of bone marrow studies.
  • Subjects with central nervous system (CNS) disease are eligible, with exceptions as noted in the exclusion criteria
  • Contraception:
  • --Individuals of child-bearing or child-fathering potential (IOCBP or IOCFP) must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the preparative regimen for IOCBP and for 4 months after receiving the preparative regimen for IOCFP
  • Cardiac function: Left ventricular ejection fraction greater than or equal to 45% or fractional shortening greater than or equal to 28%, and no clinically significant electrocardiogram (ECG) findings
  • Pulmonary Function
  • Baseline oxygen saturation >92% on room air at rest
  • Participants with respiratory symptoms must have a diffusing capacity for carbon monoxide (DLCO)/adjusted > 45%. For children who are unable to cooperate for pulmonary function tests (PFTs) they must not have dyspnea at rest or known requirement for supplemental oxygen.
  • Ability of subject, parent(s)/guardian(s), Legally Authorized Representative (LAR) or Durable Power of Attorney (DPA) to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Subjects meeting any of the following criteria are not eligible for participation in the study:
  • Recurrent or refractory ALL limited to isolated testicular.
  • Subjects with radiologically detected active CNS lymphoma or isolated CNS disease which are eligible for definitive CNS directed radiation therapy will be excluded.
  • Hyperleukocytosis (greater than or equal to 50,000 blasts/micro L) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
  • Pregnant or nursing individuals.
  • Subjects will be excluded related to the following prior therapy criteria:
Show all 25Show fewer
  • Systemic chemotherapy, anti-neoplastic investigational agents, or antibody-based therapies =<2 weeks (6 weeks for clofarabine or nitrosoureas) prior to apheresis with the following exception:
  • ---No time restriction with prior intrathecal chemotherapy, steroid therapy, hydroxyurea or ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Philadelphia chromosome (Ph)+ ALL) provided there is recovery from any acute toxic effects.
  • Radiation therapy =<3 weeks prior to apheresis with the following exception:
  • ---No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the subject has measurable/evaluable disease outside the radiation window.
  • History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
  • Less than 100 days post-transplant
  • Evidence of active graft-versus-host disease (GVHD)
  • Taking immunosuppressive agents within 30 days prior to apheresis
  • Less than 6 weeks post donor lymphocyte infusion (DLI)
  • History of prior CAR therapy or other adoptive cell therapies prior to apheresis that meet the following criteria:
  • Less than 30 days post-infusion
  • Circulating CAR T cells (or genetically modified cells) >5% by flow cytometry in peripheral blood.
  • Human Immunodeficiency Virus (HIV)/hepatitis B virus (HBV)/hepatitis C virus (HCV) Infection:
  • a. Seropositive for HIV antibody. (Participants with HIV are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy in the future should study results indicate effectiveness.)
  • b. Positive for Hepatitis B surface antigen (HbsAG).
  • c. Evidence of active Hepatitis C (evidenced by detectable HCV ribonucleic acid (RNA)
  • Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject;
  • Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission;
  • History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Background:

B-cell leukemias and lymphomas are cancers that are often difficult to treat. The primary objective of this study is to determine the ability to take a patient's own cells (T lymphocytes) and grow them in the laboratory with the cluster of differentiation 19 (CD19/cluster of differentiation 22-chimeric antigen receptor (CD22-CAR) gene through a process called 'lentiviral transduction (also considered gene therapy) and growing them to large numbers to use as a treatment for hematologic cancers in children and young adults.. Researchers want to see if giving modified CD19/CD22-CAR T cells to people with these cancers can attack cancer cells. In addition, the safety of giving these gene modified cells to humans will be tested at different cell doses. Additional objectives are to determine if this therapy can cause regression of B cell cancers and to measure if the gene modified cells survive in patients' blood.

Read more

Objective:

To study the safety and effects of giving CD19/CD22-CAR T cells to children and young adults with B-cell cancer.

Eligibility:

People ages 3-39 with certain cancers that have not been cured by standard therapy. Their cancer tissue must express the CD19 protein.

Design:

A sample of participants blood or bone marrow will be sent to National Institutes of Health (NIH) and tested for leukemia.

Participants will be screened with:

Medical history

Physical exam

Urine and blood tests (including for human immunodeficiency virus (HIV)

Heart and eye tests

Neurologic assessment and symptom checklist.

Scans, bone marrow biopsy, and/or spinal tap

Some participants will have lung tests.

Participants will repeat these tests throughout the study and follow-up.

Participants will have leukapheresis. Blood will be drawn from a plastic tube (intravenous (IV) or needle in one arm then go through a machine that removes lymphocytes. The remaining blood will be returned to the participant's other arm.

Participants will stay in the hospital about 2 weeks. There they will get:

Two chemotherapy drugs by IV

Their changed cells by IV

Standard drugs for side effects

Participants will have frequent follow-up visits for 1 year, then 5 visits for the next 4 years. Then they will answer questions and have blood tests every year for 15 years.

...

Read the detailed description

Background:

  • Acute lymphoblastic leukemia (ALL) accounts for approximately 25% of childhood cancer. Survival rates have improved, but outcomes for some subgroups, including infants and young adults remain poor, and survival for patients who relapse is < 50%, despite allogeneic stem cell transplant following second remission.
  • Cluster of differentiation 19 (CD19 immune escape has been observed by several groups following CD19-chimeric antigen receptor (CAR) therapy for B-ALL. Investigation of this phenomenon reveals a complex biology responsible for loss or downregulation of CD19 expression observed in these cases.
  • Sequential therapy using cluster of differentiation 22 (CD22)-CARs to treat CD19 dim/lo escape is associated with rapid development of resistance due to CD22 downregulation. This trial will test whether simultaneous targeting of CD19 and CD22 using a novel bivalent CD19/22-CAR is safe and feasible.

Objectives:

-Assess the safety of administering escalating doses of autologous CD19/CD22-CAR engineered T cells that meet established release specifications in children and young adults with CD19+CD22+ B cell ALL, isolated central nervous system (CNS) ALL, or lymphoma following a cyclophosphamide/fludarabine conditioning regimen.

Eligibility:

-Participants between >= 3 years and <= 39 years of age, with CD19+/CD22+ B cell ALL, isolated CNS ALL, or lymphoma who have relapsed or have refractory disease after at least one standard chemotherapy regimen and one salvage regimen, with no alternative curative options who meet standard Phase I eligibility criteria.

Design:

  • Phase I, 3 + 3 dose escalation design using the following dose levels: -1: 1 x 10^5 transduced T cells/kg (+/- 20%); 1: 3 x 10^5 transduced T cells/kg (+/- 20%); 2: 1 x 10^6 transduced T cells/kg; and 3: 3 x 10^6 transduced T cells/kg (+/- 20%); 4: 1 x 10^7 transduced T cells/kg (+/- 20%).
  • Participants will receive a lymphodepleting preparative regimen of fludarabine (25 mg/m^2/day (d) x 3 on Days -4, -3, -2) and cyclophosphamide (900 mg/m^2/d x 1 on Day -2) followed by infusion of CD19/CD22-CAR T-cells on D0. Participants who are CAR pretreated (with exception for those with an interval hematopoietic stem cell transplantation (HSCT) will receive increased lymphodepleting preparative regimen of fludarabine (30^mg/m^2/d x 4 on Days -5, -4, -3, -2) and cyclophosphamide (600 mg/m^2/d x 2 on Days -3, -2) followed by infusion of CD19/CD22-CAR T-cells on D0. If fludarabine is unavailable, pentostatin may be given as an alternative.
  • Patients will be evaluated sequentially for toxicity, antitumor effects, CAR expansion and persistence, as well as research correlatives.
Being tested
CD19/CD22 CAR T-Cells, Fludarabine, Cyclophosphamide, Apheresis, Anti-emetic
Keywords
B-Non Hodgkin Lymphoma, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, B-precursor ALL, B-All, Philadelphia chromosome + ALL, Lymphoma, CD-22 Expressing Tumor, CD-19 expressing tumor, Adoptive Immunotherapy
Medical subject headings
Lymphoma, Non-Hodgkin, Leukemia, B-Cell, Lymphoma, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Philadelphia Chromosome, Lymphoma

What participants receive

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

  • CD19/CD22 CAR T-CellsBiological

    Also called cluster of differentiation 19 chimeric antigen receptor T-cells, cluster of differentiation 22 chimeric antigen receptor T-cells

    Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22) chimeric antigen receptor (CAR) T-cells will be infused on Day 0 after lymphodepleting chemotherapy regimen.

  • FludarabineDrug

    Also called Fludara

    Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on body surface area (BSA) (25-30 mg/m^2/dose) on Days -4, -3, -2 or Days -5, -4, -3, -2.

  • CyclophosphamideDrug

    Also called Cytoxan

    Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA), at 900 mg/m^2/dose after fludarabine infusion on Day -2 or 600 mg/m^2/dose on Days -3 \& -2.

  • ApheresisProcedure or surgery

    According to institutional standards.

  • Anti-emeticOther

    Prophylaxis and treatment.

  • DiphenhydramineDrug

    Also called Benadryl, Banophen, Nytol

    Pre-medication: 0.5-1 mg/kg/dose (maximum 50 mg/dose) by mouth or intravenous over 10-15 minutes.

  • AcetaminophenDrug

    Also called Tylenol, ofirmev, FeverAll

    Pre-medication: 15 mg/kg/dose (maximum 650 mg/dose by mouth).

  • ECGDiagnostic test

    Also called Electrocardiogram

    Pre-cell infusion.

  • ECHODiagnostic test

    Also called Echocardiogram

    Pre-cell infusion.

  • MRI BrainDiagnostic test

    Also called Magnetic resonance imaging

    Pre-cell infusion.

  • Bone marrow biopsyProcedure or surgery

    Also called BM biopsy

    Pre-cell infusion.

  • Cardiac MRIDiagnostic test

    Also called Cardiac magnetic resonance imaging

    Screening

Study groups in NCT03448393
Study groupRoleWhat they receive
Dose EscalationExperimentalCluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at escalating doses.
Receives: Biological: CD19/CD22 CAR T-Cells; Drug: Fludarabine; Drug: Cyclophosphamide; Procedure: Apheresis; Other: Anti-emetic; Drug: Diphenhydramine; Drug: Acetaminophen; Diagnostic Test: ECG; Diagnostic Test: ECHO; Diagnostic Test: MRI Brain; Procedure: Bone marrow biopsy; Diagnostic Test: Cardiac MRI
Dose ExpansionExperimentalCluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22)-chimeric antigen receptor (CAR)-transduced T cells at maximum tolerated dose (MTD) or highest dose administered.
Receives: Biological: CD19/CD22 CAR T-Cells; Drug: Fludarabine; Drug: Cyclophosphamide; Procedure: Apheresis; Other: Anti-emetic; Drug: Diphenhydramine; Drug: Acetaminophen; Diagnostic Test: ECG; Diagnostic Test: ECHO; Diagnostic Test: MRI Brain; Procedure: Bone marrow biopsy; Diagnostic Test: Cardiac MRI

What is being measured

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

  1. Grades of Toxicity by Type of Toxicity

    Safety analyses will consist of tabulations of grades of toxicity by type of toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.

    Measured: From start of lymphodepleting chemotherapy regimen through 30-days after chimeric antigen receptor (CAR) infusion (approximately 5 weeks).

  2. Maximum Tolerated Dose (MTD)

    MTD is defined as the dose level immediately below the level at which the enrollment is stopped due to dose-limiting toxicity (DLT). A DLT is defined as an adverse event that is at least possibly related to the cluster of differentiation 19/cluster of differentiation 22 (CD19/CD22)-chimeric antigen receptor (CAR) T cells with onset within the first 28 days after cell infusion.

    Measured: First 28 days after cell infusion

Secondary outcomes (4)

  1. Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells

    Number of participants that have the targeted dose number of CAR cells successfully manufactured (i.e., number of participants enrolled where the correct number of cells are produces at the dose level that are enrolled) as measured by total number of viable cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22) transduced T cells.

    Measured: CAR infusion (Day 0)

  2. Overall Survival

    Overall survival (OS) will be determined as the time from the date of chimeric antigen receptor (CAR) infusion until death.

    Measured: Number of months from CAR cell infusion until date of death or time of censor (max 66.6 months)

  3. Progression-free Survival (PFS)

    PFS is assessed from the date of chimeric antigen receptor (CAR) infusion until the documentation of disease progression or death due to any cause, whichever occurs first. Disease progression was assessed by the Response Criteria Lymphoma and is defined as individual node/lesion must be abnormal with LDI>1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in longest transverse diameter of a lesion (LDI) or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm, 1.0 cm for lesions > 2 cm; and the International Working Group and is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts.

    Measured: Number of months from CAR cell infusion until time of disease progression, death, or date of censor (up to 67 months)

  4. Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive

    Clinical activity (response) in children (age ≥3 years to 17 years) and young adults (age 18 years to ≤ 39 years) was measured by the Response Criteria Lymphoma. Complete Response (CR) is complete metabolic and/or radiographic response. Partial Response (PR) is partial metabolic response or partial remission. Stable Disease (SD) is no metabolic response or 50% decrease from baseline in the sum of products of diameters (SPD) of up to 6 dominant measurable nodes and extra nodal sites. Progressive Disease (PD) is individual node/lesion must be abnormal with longest transverse diameter of a lesion (LDI) >1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in LDI or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm and/or 1.0 cm for lesions > 2 cm; also assessed by the International Working Group and PD is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts.

    Measured: At Day 28 (+/- 4 days) after CAR cell infusion

Timeline

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

  1. First posted28 Feb 2018
  2. Study start26 Mar 2018
  3. Primary completion10 Jul 2024
  4. Study completion13 Jan 2025

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448393
Sponsor's protocol ID
180059
Other IDs
18-C-0059
Status last verified
May 2025
First submitted
27 Feb 2018
Last updated
4 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Publications

  • Silbert SK, Gava F, Yates B, Rankin AW, Rocco JM, Shao L, Dreyzin A, Cai Y, Lamplugh C, Han KL, Prochazkova M, Little L, Foley T, Sankaran H, Martin K, Garces P, Jin P, Chien CD, Taylor N, Fry TJ, Yuan CM, Wang HW, Stroncek DF, Highfill SL, Shalabi H, Shah NN. CD19/CD22 bivalent CAR T cells in children, adolescents and young adults with B-ALL: final phase 1 trial results. J Immunother Cancer. 2026 Jun 5;14(6):e015296. doi: 10.1136/jitc-2026-015296.

    PubMed 42248607

  • Aminov S, Giricz O, Melnekoff DT, Sica RA, Polishchuk V, Papazoglu C, Yates B, Wang HW, Sahu S, Wang Y, Gordon-Mitchell S, Leshchenko VV, Schinke C, Pradhan K, Aluri S, Sohn M, Barta SK, Agarwal B, Goldfinger M, Mantzaris I, Shastri A, Matsui W, Steidl U, Brody JD, Shah NN, Parekh S, Verma A. Immunotherapy-resistant acute lymphoblastic leukemia cells exhibit reduced CD19 and CD22 expression and BTK pathway dependency. J Clin Invest. 2024 Feb 20;134(8):e175199. doi: 10.1172/JCI175199.

    PubMed 38376944

  • Silbert SK, Madan S, Holland EM, Steinberg SM, Little L, Foley T, Epstein M, Sarkisian A, Lee DW, Nikitina E, Kakumanu S, Ruppin E, Shalabi H, Yates B, Shah NN. A comprehensive analysis of adverse events in the first 30 days of phase 1 pediatric CAR T-cell trials. Blood Adv. 2023 Sep 26;7(18):5566-5578. doi: 10.1182/bloodadvances.2023009789.

    PubMed 37486616

  • Shalabi H, Qin H, Su A, Yates B, Wolters PL, Steinberg SM, Ligon JA, Silbert S, DeDe K, Benzaoui M, Goldberg S, Achar S, Schneider D, Shahani SA, Little L, Foley T, Molina JC, Panch S, Mackall CL, Lee DW, Chien CD, Pouzolles M, Ahlman M, Yuan CM, Wang HW, Wang Y, Inglefield J, Toledo-Tamula MA, Martin S, Highfill SL, Altan-Bonnet G, Stroncek D, Fry TJ, Taylor N, Shah NN. CD19/22 CAR T cells in children and young adults with B-ALL: phase 1 results and development of a novel bicistronic CAR. Blood. 2022 Aug 4;140(5):451-463. doi: 10.1182/blood.2022015795.

    PubMed 35605184

  • Singh N. Modified T cells as therapeutic agents. Hematology Am Soc Hematol Educ Program. 2021 Dec 10;2021(1):296-302. doi: 10.1182/hematology.2021000262.

    PubMed 34889384

  • Molina JC, Steinberg SM, Yates B, Lee DW, Little L, Mackall CL, Shalabi H, Shah NN. Factors Impacting Overall and Event-Free Survival following Post-Chimeric Antigen Receptor T Cell Consolidative Hematopoietic Stem Cell Transplantation. Transplant Cell Ther. 2022 Jan;28(1):31.e1-31.e9. doi: 10.1016/j.jtct.2021.10.011. Epub 2021 Oct 20.

    PubMed 34687939

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19/CD22 CAR T-Cells, Fludarabine and Cyclophosphamide in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, B Cell, run by National Cancer Institute (NCI) at 1 site in United States.

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 29 inclusion and 25 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Grades of Toxicity by Type of Toxicity (time frame: From start of lymphodepleting chemotherapy regimen through 30-days after chimeric antigen receptor (CAR) infusion (approximately 5 weeks).). The study lists 2 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 NCT03448393, which also lists 6 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 4 Jun 2025.

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