Spots Global Cancer Trial Database for Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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Trial Identification
Brief Title: Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Official Title: Protocol H125001: An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma
Study ID: NCT03430011
Conditions
Study Description
Brief Summary: This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose. The safety and tolerability of JCARH125 in subjects who receive prophylactic treatment with anakinra will be evaluated in a separate Phase 1 cohort. The antitumor activity of JCARH125 in subjects who have been previously treated with BCMA-directed therapy will be evaluated in separate Phase 2a cohorts.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 0006, Birmingham, Alabama, United States
Local Institution - 0007, Duarte, California, United States
Local Institution - 0059, Los Angeles, California, United States
Local Institution - 0010, San Francisco, California, United States
Local Institution - 0060, Denver, Colorado, United States
Local Institution - 0042, Atlanta, Georgia, United States
Local Institution - 0016, New Lenox, Illinois, United States
Local Institution - 0061, Indianapolis, Indiana, United States
Local Institution - 0053, Westwood, Kansas, United States
Local Institution - 0009, Baltimore, Maryland, United States
Local Institution - 0005, Boston, Massachusetts, United States
Local Institution - 0062, Detroit, Michigan, United States
Local Institution - 0054, Rochester, Minnesota, United States
Local Institution - 0038, Hackensack, New Jersey, United States
Local Institution - 0013, Buffalo, New York, United States
Local Institution - 0001, New York, New York, United States
Local Institution - 0058, Portland, Oregon, United States
Local Institution - 0023, Seattle, Washington, United States
Local Institution - 0018, Seattle, Washington, United States
Local Institution - 0055, Milwaukee, Wisconsin, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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