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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 is a Phase 1 study that was terminated before completion, run by Precision BioSciences. The registered enrollment target is 48 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04171843
The ClinicalTrials.gov registry entry for NCT04171843 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Precision BioSciences, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04171843 reports 0 study locations.
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.
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