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Evaluating JCAR017 for treating relapsed or refractory B-cell Non-Hodgkin Lymphoma

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)

Phase 2 Interventional Celgene · NCT04245839

This study is testing a new treatment called JCAR017 to see if it can help adults with certain types of B-cell Non-Hodgkin Lymphoma that have come back or didn't respond to other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment276 (estimated)
Ages18 Years and up
SexAll
SponsorCelgene Industry-sponsored
Drugs / interventionsCAR T, chemotherapy
Locations59 sites (Santa Monica, California and 58 other locations)
Trial IDNCT04245839 on ClinicalTrials.gov

What this trial studies

This global Phase 2 clinical trial assesses the efficacy and safety of JCAR017 in adults with relapsed or refractory follicular lymphoma or marginal zone lymphoma. The study involves a single-arm, multicohort design and includes three periods: pretreatment, treatment, and posttreatment. During the treatment phase, patients will receive lymphodepleting chemotherapy followed by JCAR017 administration, with follow-up assessments for disease status and safety extending over five years.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory follicular lymphoma or marginal zone lymphoma who have received prior therapies including anti-CD20 and alkylating agents.

Not a fit: Patients who have not received prior systemic therapy or those with aggressive forms of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of B-cell Non-Hodgkin Lymphoma.

How similar studies have performed: Other studies have shown promising results with CAR T-cell therapies in similar patient populations, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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
2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
3. 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)
4. 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
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ function
7. Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

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

Where this trial is running

Santa Monica, California and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma, Non-HodgkinB-cell Non-Hodgkin LymphomaJCAR017Relapsed or RefractoryFollicular LymphomaMarginal Zone Lymphoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.