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

Part of paid clinical trials in Duarte, California.

Sponsor
Sanofi
Study ID
NCT06508489
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAR443579 — BIOLOGICAL
    Pharmaceutical form: Powder for solution for infusion Route of administration: intravenous infusion
  • venetoclax — DRUG
    Pharmaceutical form :Film coated tablet Route of administration: oral
  • azacitidine — DRUG
    Pharmaceutical form: Lyophilized powder for suspension for injection Route of administration: intravenous or subcutaneous

Study Details

This is a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or adult participants with CD123 expressing hematological malignancies. This protocol is structured as a master protocol (containing common protocol elements). Individual sub-studies will explore SAR443579 with combination partners, which may include approved or investigational agents. Experimental sub-studies will be tested through 3 parts: Part 1: dose finding (such as dose escalation/ safety run-in). Part 2: dose optimization (when applicable). Part 3: dose expansion. In each sub-study, a dose escalation will identify preliminary recommended dose for expansion (pRDE) of SAR443579 and its respective combination partner. Following the determination of the preliminary RDE, additional participants will be enrolled in the dose expansion part, or if dose optimization needs to be further evaluated, additional participants will be enrolled in the "dose optimization/expansion" part. Dose optimization and dose expansion part could involve randomization depending on specific sub-study design. Study will consist of a screening period, treatment period, and follow-up period. Participants will receive study treatment until documented disease progression, unacceptable adverse events, participant's decision to stop study treatment, or completion of the maximum cycles allowed in the sub-studies, or the participant meets other criteria for discontinuation per study protocol (whichever occurs first).

Key Dates

Start date
Aug 13, 2024
Status verified
Aug 2025
Primary completion
Aug 8, 2025
Completion
Aug 8, 2025

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 01: SAR443579 + azacitidine + venetoclax
    Part 1: Safety run-in: SAR443579 treatment will begin with an identified starting dose. Safety run-in will proceed according to the incidence of DLTs.

Primary Outcome Measure

Number of participants with adverse events (AEs)/serious adverse events (SAEs)/adverse events of special interest (AESIs), laboratory abnormalities [ Time Frame: Day 1 to 30 days after the last administration of study treatment ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center- Site Number : 8400003DuarteCalifornia91010-
Montefiore Medical Center - Moses Campus- Site Number : 8400004The BronxNew York10467-
The Ohio State University Wexner Medical Center - Ohio State Outpatient Care Upper Arlington- Site Number : 8400001ColumbusOhio43221-
Oregon Health and Science University- Site Number : 8400006PortlandOregon97239-
The University of Texas MD Anderson Cancer Center- Site Number : 8400008HoustonTexas77030-

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City of Hope National Medical Center· Duarte, CAMontefiore Medical Center - Moses Campus· The Bronx, NYThe Ohio State University Wexner Medical Center - Ohio State Outpatient Care Upper Arlington· Columbus, OHOregon Health and Science University· Portland, ORThe University of Texas MD Anderson Cancer Center· Houston, TX

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