MedTrace Logo

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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-09-21

No results posted yet for this study

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

Conditions

Interventions

GENETIC

PBCAR269A

Allogeneic anti-BCMA CAR T-cell

DRUG

Fludarabine

Fludarabine is used for lymphodepletion.

DRUG

Cyclophosphamide

Cyclophosphamide is used for lymphodepletion.

DRUG

Nirogacestat

Allogeneic anti-BCMA CAR T-cell

Sponsors & Collaborators

  • Precision BioSciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Monika Vainorius, MD · Precision BioSciences, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2022-10-19
Completion
2022-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171843 on ClinicalTrials.gov