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

• Status: Recruiting
• Trial end date: 2024-04-29
• Target enrollment: 0
• Participant gender: All

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 for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

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 2 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

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