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)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

The primary objective of the study is to evaluate the efficacy of JCAR017 in subjects with r/r follicular lymphoma and marginal zone lymphoma.

Secondary Objectives:

To evaluate other measures of efficacy
To evaluate the safety of JCAR017
To characterize the pharmacokinetic (PK) profile of JCAR017
To evaluate the Health-Related-Quality of Life (HRQoL) using preselected primary domains of interest in the EORTC QLQ-C30 (global health/QoL, physical functioning, cognitive functioning, fatigue, pain) and FACT-LymS (lymphoma specific symptoms)

Eligibility

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

Locations

4100 John R
Detroit, MI 48201
Get Directions

Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions

Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices