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A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies

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NCT06508489

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase
Phase 1/2
Status
Terminated
Study type
Interventional
Design
Na · None · Treatment
Enrollment
7actual
Sites
7
Countries
Australia, United States

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
DateFiledBasisWhat it is
Start2024-08-13actualWhen the study began enrolling
Primary completion2025-08-08actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-08-08actualThe whole study's end, after follow-up
First posted2024-07-18actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-08-22actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Acute Myeloid Leukemia

Interventions

  • Biological: SAR443579
  • Drug: venetoclax — also filed as VENCLYXTO / VENCLEXTA
  • Drug: azacitidine

Primary outcomes

what the primary-completion date above is the date OF
Number of participants with adverse events (AEs)/serious adverse events (SAEs)/adverse events of special interest (AESIs), laboratory abnormalities
measured Day 1 to 30 days after the last administration of study treatment
Substudy 01: Incidence of dose limiting toxicities (DLTs) (escalation part)
measured Day 1 to Day 28
Substudy 01: Complete Remission (CR) rate (optimization part)
measured Day 1 to 30 days after the last administration of study treatment
Substudy 01: Complete Remission (CR) rate (expansion part)
measured Day 1 up to 6 months

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