RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2020-07-14
Study Completion:2031-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04245839

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
  3. 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. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. 6. Adequate organ function
  7. 7. Adequate vascular access for leukapheresis procedure
  1. 1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
  2. 2. WHO subclassification of duodenal-type FL
  3. 3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
  4. 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. 5. Prior CAR T-cell or other genetically-modified cell therapy
  6. 6. History of or active human immunodeficiency virus (HIV)
  7. 7. Active hepatitis B or active hepatitis C
  8. 8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
  9. 9. Active autoimmune disease requiring immunosuppressive therapy
  10. 10. Presence of acute or chronic graft-versus-host=disease
  11. 11. History of significant cardiovascular disease
  12. 12. History or presence of clinically relevant central nervous system pathology
  13. 13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 111
Santa Monica, California, 90095
United States
University Of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Local Institution - 105
New Haven, Connecticut, 06520
United States
Local Institution - 0601
Hollywood, Florida, 33021
United States
Local Institution - 125
Hollywood, Florida, 33021
United States
Washington University School Of Medicine
Miami, Florida, 33136
United States
Northwestern University
Chicago, Illinois, 60611
United States
Local Institution - 109
Niles, Illinois, 60714
United States
Local Institution - 122
Iowa City, Iowa, 52242
United States
Local Institution - 124
Wichita, Kansas, 67124
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 - 118
Detroit, Michigan, 48202
United States
Local Institution - 123
Morristown, New Jersey, 07960
United States
Local Institution - 116
New York, New York, 10021
United States
Local Institution - 110
Charlotte, North Carolina, 28204
United States
Local Institution - 120
Fargo, North Dakota, 58122
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 - 126
Knoxville, Tennessee, 37920
United States
Local Institution - 121
Dallas, Texas, 75230-2510
United States
Local Institution - 104
Houston, Texas, 77030
United States
Local Institution - 119
Houston, Texas, 77030
United States
Local Institution - 115
Charlottesville, Virginia, 22903
United States
Local Institution - 108
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-14
Study Completion Date2031-09-30

Study Record Updates

Study Start Date2020-07-14
Study Completion Date2031-09-30

Terms related to this study

Keywords Provided by Researchers

  • B-cell Non-Hodgkin Lymphoma (NHL)
  • JCAR017
  • Relapsed or Refractory
  • Follicular Lymphoma
  • Marginal Zone Lymphoma

Additional Relevant MeSH Terms

  • Lymphoma, Non-Hodgkin