Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

213

Study ID:

NCT04245839

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 38 Locations for this study

See Locations Near You

Local Institution - 111
Santa Monica California, 90095, United States
Local Institution - 107
Aurora Colorado, 80045, United States
Local Institution - 105
New Haven Connecticut, 06520, United States
Local Institution - 103
Chicago Illinois, 60611, United States
Local Institution - 109
Niles Illinois, 60714, United States
Local Institution - 102
Baltimore Maryland, 21201, United States
Local Institution - 100
Boston Massachusetts, 02114, United States
Local Institution - 101
Boston Massachusetts, 02215, United States
Local Institution - 116
New York New York, 10021, United States
Local Institution - 110
Charlotte North Carolina, 28204, United States
Local Institution - 112
Cleveland Ohio, 44195, United States
Local Institution - 114
Portland Oregon, 97213, United States
Local Institution - 117
Philadelphia Pennsylvania, 19104, United States
Local Institution - 113
Sioux Falls South Dakota, 57105, United States
Local Institution - 104
Houston Texas, 77030, United States
Local Institution - 115
Charlottesville Virginia, 22903, United States
Local Institution - 108
Seattle Washington, 98109, United States
Local Institution - UNK-201
Salzburg , 5020, Austria
Local Institution - 450
Wien , 1090, Austria
Local Institution - 150
Toronto Ontario, M5G 2, Canada
Local Institution - 151
Montreal Quebec, H1T 2, Canada
Local Institution - 252
Lille , 59037, France
Local Institution - 251
Montpellier CEDEX 5 , 34295, France
Local Institution - 250
Pierre-Benite CEDEX , 69495, France
Local Institution - 501
Köln , 50937, Germany
Local Institution - 502
Munich , 81377, Germany
Local Institution - 500
Ulm , 89081, Germany
Local Institution - 300
Bergamo , 24127, Italy
Local Institution - 301
Naples , 80131, Italy
Local Institution - 553
Sapporo-shi Hokkaido, 06086, Japan
Local Institution - 550
Chuo-ku Tokyo, 104-0, Japan
Local Institution - 551
Minato-ku Tokyo, 105-8, Japan
Local Institution - 552
Fukuoka , 812-8, Japan
Local Institution - 350
Salamanca , 37007, Spain
Local Institution - 351
Sevilla , 41013, Spain
Local Institution - 600
Stockholm , 14186, Sweden
Local Institution - 200
London , NW1 2, United Kingdom
Local Institution - 201
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

213

Study ID:

NCT04245839

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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