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NCT05086315 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT05086315: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT05086315 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 101 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05086315, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.
Primary Outcome
The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs i
Interventions
- DRUG SAR443579
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2025-06-13 |
| Phase | Phase 1 |
Why NCT05086315 stopped before completion
NCT05086315 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 1 intervention - of which SAR443579 is the first listed.
NCT05086315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05086315 about?
NCT05086315 is a clinical study titled "First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)". This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.
What is the current status of trial NCT05086315?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2021-12-08. Estimated completion is 2025-06-13.
What interventions are being tested in trial NCT05086315?
The interventions under investigation include: SAR443579 (DRUG).
Who is sponsoring clinical trial NCT05086315?
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 NCT05086315's enrollment target sits among peer trials
101 546th of 2000 higher than 1,455 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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