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NCT05712278 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT05712278: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT05712278 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05712278, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and cytarabine conditioning for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). Adult participants with R/R AML will be eligible for treatment. The study is intended to assess the candidate dose(s) by the occurrence of dose-limiting toxicity (DLT) from start of chemotherapy until 28 days after the first administration of SAR445419. The duration of the study for a participant will include: * Screening period up to 21 days prior to initiating chemotherapy, * Treatment period of 5 days chemotherapy followed by SAR445419 administered for 2 weeks and end of treatment visit 56 days after first SAR445419 administration, * Survival follow-up period up to 1 year after the last participant has started treatment with SAR445419.
Interventions
- DRUG fludarabine
- DRUG cytarabine
- DRUG SAR445419
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2024-03-12 |
| Phase | Phase 1 |
Why NCT05712278 stopped before completion
NCT05712278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which fludarabine is the first listed.
NCT05712278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05712278 about?
NCT05712278 is a clinical study titled "A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia". This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and cytarabine conditioning for the treatment of relapsed or refractory acute myel...
What is the current status of trial NCT05712278?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2023-06-16. Estimated completion is 2024-03-12.
What interventions are being tested in trial NCT05712278?
The interventions under investigation include: fludarabine (DRUG), cytarabine (DRUG), SAR445419 (DRUG).
Who is sponsoring clinical trial NCT05712278?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05712278's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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