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

About

Brief 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 5 years.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

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

Exclusion Criteria:

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)
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