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A New Study Evaluating the Activity of Modular CAR T for mYeloma — MCARTY  

Multiple Myeloma Clinical Trial

Official title:
An Open Label, Phase 1 Study Evaluating the Activity of Modular CAR T for mYeloma

Clinical Trial Summary

This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.

Clinical Trial Description

This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA CAR alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with triple refractory Multiple Myeloma. The first 3-6 patients will be treated at the lower dose of BCMA CAR T cells in cohort 1 (50 x 10^6 cells). If the lower dose is deemed tolerable, recruitment into cohort 1 at a higher dose (150 x 10^6 BCMA CAR T cells) and cohort 2 at a dose of 50 x 10^6 BCMA/CD19 cells will begin in parallel. - If the 50 x 10^6 cells BCMA/CD19 CAR dose in cohort 2 is deemed intolerable, then no further patients will be recruited to cohort 2. - If both 150 x 10^6 cells BCMA CAR (cohort 1) and 50 x 106 cells BCMA/CD19 CAR (cohort 2) are deemed tolerable then recruitment will begin to a higher BCMA/CD19 CAR dose of 150 x 10^6 cells. - If 150 x 10^6 cells BCMA CAR is intolerable and 50 x 10^6 cells BCMA/CD19 CAR is tolerable then no further patients will be recruited to cohorts 1 or 2. A Summary of dosing on trial is outlined below: Cohort 1 (BCMA CAR-T cells) - Dose level 1: 50x10^6 BCMA CAR-T cells - Dose level 2: 150x10^6 BCMA CAR-T cells Cohort 2 (BCMA/CD19 CAR-T cells) - Dose level 1: 50x10^6 BCMA/CD19 CAR-T cells - Dose level 2: 150x10^6 BCMA/CD19 CAR-T cells ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04795882
Study type Interventional
Source University College, London
Contact
Status Enrolling by invitation
Phase Phase 1
Start date April 22, 2022
Completion date December 31, 2035
View Details
See also
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