NCT04171843: Phase 1/2: Allogeneic anti-BCMA CAR T cells PBCAR269A With or Without Nirogacestat RRMM

NCT04171843: Phase 1/2: PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma

allogeneic anti-BCMA CAR T cells PBCAR269A

A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma

This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A, with or without nirogacestat, in adults with r/r MM.

Study subjects in Cohort A will receive PBCAR269A and study subjects in Cohort B will receive PBCAR269A and nirogacestat. At each dose level, study subjects in Cohort A and Cohort B will receive the same dose of PBCAR269A. In Cohort B, all study subjects will follow the same dosing regimen of nirogacestat.

Sponsor

Precision BioSciences, Inc

Multiple Locations

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ClinicalTrials.gov Identifier: NCT04171843

Official Title: A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma

First Posted : November 21, 2019

Click here for details on ClinicalTrials.gov

Click here for details on Cancer.gov

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PBCAR269A

allogeneic anti-BCMA-CAR T cells PBCAR269A

Allogeneic Anti-BCMA-CAR T-cells PBCAR269A (Code C171066)

Allogeneic Anti-BCMA-CAR T-cells PBCAR269A

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Genetic: PBCAR269A

allogeneic anti-BCMA-CAR T cells PBCAR269A

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: Nirogacestat

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Nirogacestat

Nirogacestat (Code C82383)

Nirogacestat

NIROGACESTAT

PF-03084014

gamma secretase inhibitor PF-03084014

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- California: University of California San Francisco

- California: City of Hope Duarte

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- Texas: The University of Texas MD Anderson Cancer Center Houston

- New York: Columbia University Medical Center New York

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Locations

United States, California

United States, Massachusetts

United States, New York

United States, Texas