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

Description

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.

Conditions

Lymphoma, Non-Hodgkin

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Lymphoma, Non-Hodgkin
Intervention / Treatment

-

Contacts and Locations

Santa Monica

Local Institution - 111, Santa Monica, California, United States, 90095

Aurora

University Of Colorado Cancer Center, Aurora, Colorado, United States, 80045

New Haven

Local Institution - 105, New Haven, Connecticut, United States, 06520

Hollywood

Local Institution - 0601, Hollywood, Florida, United States, 33021

Hollywood

Local Institution - 125, Hollywood, Florida, United States, 33021

Miami

Washington University School Of Medicine, Miami, Florida, United States, 33136

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Niles

Local Institution - 109, Niles, Illinois, United States, 60714

Iowa City

Local Institution - 122, Iowa City, Iowa, United States, 52242

Wichita

Local Institution - 124, Wichita, Kansas, United States, 67124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celgene,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-09-30