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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 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 101 participants.
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.
Interventions
- DRUG SAR443579
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2025-06-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05086315
The ClinicalTrials.gov registry entry for NCT05086315 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 101 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 1 intervention - of which SAR443579 is the first listed.
NCT05086315 reports 0 study locations.
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.
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