A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.
This is an open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; zevor-cel/CT053) in patients with relapsed and or refractory multiple myeloma. Phase 1b of the study will be dose escalation followed by an expansion cohort. After recommended Phase 2 dose is identified in Phase 1b, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (zevor-cel). Following manufacture of the drug product, subjects will receive lymphodepletion prior to zevor-cel infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving zevor-cel for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo a 15-year long-term follow-up study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion
Mayo Clinic Hospital
Phoenix, Arizona, United States
UCSF
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Incidence of Treatment Related adverse events (AEs)
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Time frame: Day 1 - Month 60
Identification of Maximum Tolerated Dose (MTD)
Incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 - Month 60
Objective response rate
Objective response rate (ORR) per IMWG by IRC read
Time frame: Day 1 - Month 60
Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM
Disease-specific response criteria including, but not limited to: complete response (CR), MRD, very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, Time to Response, Time to Progression, Progression Free Survival, best response and Overall Survival
Time frame: Day 1 - Month 60
Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment
ORR, DOR, FPS, OS, MRD, time to response, time to progression, best tumor response
Time frame: Day 1 - Month 60
Evaluate zevor-cel PK profile
CAR transgene copy number, peak value, AUC, in vivo persistence
Time frame: Day 1 - Month 60
Evaluate ADA profile
Percentage of patients with anti-zevor-cel drug antibodies
Time frame: Day 1 - Month 60
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Moffitt Cancer Center
Tampa, Florida, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
Mayo
Rochester, Minnesota, United States
TriStar CMC
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Methodist Hosptial
Houston, Texas, United States
...and 3 more locations
Evaluate HRQoL in patients with rrMM from baseline up to study completion
Change from baseline in HRQoL as measured by EORTC QLQ-C30 and QLQ-MY20
Time frame: Day 1 - Month 60
Evaluate utilization of hospital resources
Duration of hospitalization and ICU
Time frame: Day 1 - Month 60