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)
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Phase
Phase 1/2
Status
Terminated
Study type
Interventional
Design
Na · None · Treatment
Enrollment
101actual
Sites
23
Countries
Australia, China, France +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-12-08 | actual | When the study began enrolling |
| Primary completion | 2025-06-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-13 | actual | The whole study's end, after follow-up |
| First posted | 2021-10-20 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-06 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Lymphocytic Leukaemia
- Acute Myeloid Leukaemia Refractory
- Myelodysplastic Syndromes
- Blastic Plasmacytoid Dendritic Cell Neoplasia
Intervention
- Drug: SAR443579
Primary outcomes
what the primary-completion date above is the date OFDose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
measured Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Escalation (Cohort C): Number of Participants With Dose Limiting Toxicities
measured Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Expansion (Cohorts A1, A2 and D): Composite Complete Remission (CRc) Rate
measured Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohort B): Overall Response Rate (ORR)
measured Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-07-23 · 2.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-07-23 · 615 KB · SAP_001.pdf
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