Spots Global Cancer Trial Database for A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
Official Title: A Phase I, Multi Center, Open Label Study of CC-98633, BCMA Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma
Study ID: NCT04394650
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in participants with relapsed and/or refractory multiple myeloma. 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-98633 to establish a recommended Phase 2 dose RP2D(s); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D(s).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 103, Birmingham, Alabama, United States
Local Institution - 111, Phoenix, Arizona, United States
Local Institution - 110, Stanford, California, United States
Local Institution - 107, Chicago, Illinois, United States
The University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States
Local Institution - 109, Rochester, Minnesota, United States
Local Institution - 106, Buffalo, New York, United States
Local Institution - 104, New York, New York, United States
Local Institution - 102, New York, New York, United States
Local Institution - 108, Charlotte, North Carolina, United States
Local Institution - 105, Dallas, Texas, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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