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NCT03502577: Phase 1 - BCMA-Specific CAR T-Cells Combined With Gamma Secretase Inhibitor (JSMD194)

Updated: May 28


NCT03502577: Phase 1 - BCMA-Specific CAR T-Cells Combined With a Gamma Secretase Inhibitor (JSMD194) to Treat Relapsed or Persistent Multiple Myeloma

This phase I trial determines the side effects and best dose of B-cell maturation antigen (BCMA)-chimeric antigen receptor (CAR) T-cells when combined with gamma-secretase inhibitor LY3039478 (JSMD194), cyclophosphamide, and fludarabine in treating participants with multiple myeloma that that has come back or remains despite treatment. Placing genes added in the laboratory into immune T-cells may make the T-cells recognize BCMA, a protein on the surface of cancer cells. JSMD194 may enhance the killing of cancer cells by increasing the BCMA expression on multiple myeloma cells, making the targeted BCMA CAR-T treatment more effective. JSMD194 also decreases the amount of BCMA found in the circulation (called soluble BCMA) that is not bound to the myeloma cells.


JSMD194 can therefore reduce the potential for soluble BCMA to act as a decoy. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BCMA CAR T therapy with JSMD194, cyclophosphamide, and fludarabine may work better in treating participants with relapsed or persistent multiple myeloma.


Sponsor

Fred Hutchinson Cancer Research Center


Collaborators

Juno Therapeutics, Inc.

The Leukemia and Lymphoma Society

 

ClinicalTrials.gov Identifier: NCT03502577

Official Title: A Phase I Study of B-Cell Maturation Antigen (BCMA)-Specific Chimeric Antigen Receptor T Cells in Combination With JSMD194, a Small Molecule Inhibitor of Gamma Secretase, in Patients With Relapsed or Persistent Multiple Myeloma

First Posted : April 18, 2018

Click here for details on ClinicalTrials.gov

 

Biological: BCMA-specific CAR-expressing T Lymphocytes

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: Gamma-Secretase Inhibitor LY3039478

JSMD194

LY 3039478

crenigacestat

 

653.Myeloma: Therapy, excluding Transplantation| November 13, 2019

Response to Bcma CAR-T Cells Correlates with Pretreatment Target Antigen Density and Is Improved By Small Molecule Inhibition of Gamma Secretase

https://doi.org/10.1182/blood-2019-129582


704.Cellular Immunotherapies: Clinical| November 5, 2021

Safety and Efficacy of Fully Human BCMA CAR T Cells in Combination with a Gamma Secretase Inhibitor to Increase BCMA Surface Expression in Patients with Relapsed or Refractory Multiple Myeloma

https://doi.org/10.1182/blood-2021-154170

 

Location

United States, Washington

Washington: Fred Hutchinson Cancer Center Seattle

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