Spots Global Cancer Trial Database for A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Official Title: A Phase 1, Multicenter, Open-label Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Study ID: NCT04231747
Interventions
Study Description
Brief Summary: This is a Phase 1, first-in-human, open-label, multicenter study of CC-97540, CD19-targeted NEX-T chimeric antigen receptor (CAR) T cells, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-97540 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-97540 at the RP2D.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 003, Birmingham, Alabama, United States
Local Institution - 004, Atlanta, Georgia, United States
Local Institution - 011, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Nebraska Medicine Fred and Pamela Buffett Cancer Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Local Institution - 001, New York, New York, United States
Local Institution - 008, New York, New York, United States
Local Institution - 010, Charlotte, North Carolina, United States
Oregon Health and Science University OHSU, Portland, Oregon, United States
Huntsman Cancer Institute - University of Utah, Salt Lake City, Utah, United States
Foothills Medical Centre - Tom Baker Cancer Centre, Calgary, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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