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NCT04171843 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Precision BioSciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT04171843: Clinical Trial Phase 1 study, sponsored by Precision BioSciences.
NCT04171843 is a Phase 1 study that was terminated before completion, run by Precision BioSciences. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04171843, a Phase 1 study, was terminated before completion, sponsored by Precision BioSciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
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
Primary Outcome
To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Nirogacestat
- GENETIC PBCAR269A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-04-30 |
| Est. Completion | 2022-10-19 |
| Phase | Phase 1 |
Why NCT04171843 stopped before completion
NCT04171843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04171843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04171843 about?
NCT04171843 is a clinical study titled "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 sub...
What is the current status of trial NCT04171843?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-04-30. Estimated completion is 2022-10-19.
What interventions are being tested in trial NCT04171843?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Nirogacestat (DRUG), PBCAR269A (GENETIC).
Who is sponsoring clinical trial NCT04171843?
This trial is sponsored by Precision BioSciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04171843's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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