drugset / Trial / NCT04171843

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

NCT04171843

Phase 1 Terminated 48 enrolled Precision BioSciences, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

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. This study was terminated prior to beginning of Phase II due to lack of sufficient therapeutic effect

Timeline

Start
2020-04-30
Primary completion
2022-10-19
Completion
2022-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Nirogacestat Small molecule
Subject PBCAR269A Cell therapy 600000 cells/kg Intravenous
Subject PBCAR269A Cell therapy 2e+06 cells/kg Intravenous
Subject PBCAR269A Cell therapy 6e+06 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule