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CAR T-cell Therapy

PBCAR269A at Dose Level 1 (Cohort A) for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Precision BioSciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing a new drug, PBCAR269A, for safety and effectiveness in treating adults with relapsed or refractory myeloma. The trial is divided into two groups, with one group receiving PBCAR269A and nirogacestat, and the other group receiving just PBCAR269A. The goal is to see if PBCAR269A is safe and effective in treating myeloma.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of PBCAR269A
Secondary outcome measures
Number of Participants with Dose Limiting Toxicity(ies)
Objective Response Rate of Patients

Trial Design

6Treatment groups
Experimental Treatment
Group I: PBCAR269A at Dose Level 3 (Cohort B)Experimental Treatment4 Interventions
6 × 10\^6 CAR T cells/kg body weight.
Group II: PBCAR269A at Dose Level 3Experimental Treatment3 Interventions
6 × 10\^6 CAR T cells/kg body weight.
Group III: PBCAR269A at Dose Level 2 (Cohort B)Experimental Treatment4 Interventions
2 × 10\^6 CAR T cells/kg body weight.
Group IV: PBCAR269A at Dose Level 2Experimental Treatment3 Interventions
2 × 10\^6 CAR T cells/kg body weight.
Group V: PBCAR269A at Dose Level 1 (Cohort B)Experimental Treatment4 Interventions
6 x 10\^5 CAR T cells/kg body weight.
Group VI: PBCAR269A at Dose Level 1 (Cohort A)Experimental Treatment3 Interventions
The starting dose of PBCAR269A will be 6 x 10\^5 CAR T cells/kg body weight.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Find a Location

Who is running the clinical trial?

Precision BioSciences, Inc.Lead Sponsor
4 Previous Clinical Trials
235 Total Patients Enrolled
Monika Vainorius, MDStudy ChairPrecision BioSciences, Inc.
6 Previous Clinical Trials
504 Total Patients Enrolled
~9 spots leftby Sep 2025
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