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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 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 7 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05712278
The ClinicalTrials.gov registry entry for NCT05712278 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which fludarabine is the first listed.
NCT05712278 reports 0 study locations.
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.
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