Last updated on April 2020

Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma

Brief description of study

A phase 1b, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.

Detailed Study Description

This is an open label, multi-center, phase 1b clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; CT053) in patients with relapsed and or refractory multiple myeloma.

Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT053). Following manufacture of the drug product, subjects will receive lymphodepletion prior to CT053 infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving CT053 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.

Clinical Study Identifier: NCT03915184

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Moffitt Cancer Center

Tampa, FL United States
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Dana Farber Cancer Center

Boston, MA United States
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Rochester, MN United States
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MD Anderson

Houston, TX United States
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Mayo Clinic Hospital

Phoenix, AZ United States
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University of Michigan

Ann Arbor, MI United States
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