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
participants needed

188
sponsor

Celgene

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Updated on 19 February 2024

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cyclophosphamide

fludarabine

lymphoma

hodgkin's disease

systemic therapy

b-cell lymphoma

follicular lymphoma

marginal zone lymphoma

leukapheresis

refractory follicular lymphoma

alkylating agents

non-hodgkin lymphoma

malt

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.

Details

Condition	Lymphoma
Age	18years - 100years
Treatment	Cyclophosphamide, Fludarabine, JCAR017
Clinical Study Identifier	NCT04245839
Sponsor	Celgene
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 or two prior lines of systemic therapy are eligible if they present with high risk features. Patients that received three 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)
	Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
	Adequate organ function
	Adequate vascular access for leukapheresis procedure
Exclusion Criteria
	Evidence 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 T-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

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Step 4 Get your study results

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Study Definition

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