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An open-label, first-in-human, dose-escalation/expansion study of SAR443579 administered as single agent by intravenous infusion in adult and pediatric 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)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508357-58-00
Acronym
TCD17197
Enrollment
57
Registered
2024-03-11
Start date
2022-07-04
Completion date
2025-03-12
Last updated
2025-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphocytic leukaemia- Acute myeloid leukaemia refractory - Myelodysplastic syndrome - Blastic plasmacytoid dendritic cell neoplasia

Brief summary

Escalation Part: Incidence of dose-limiting toxicity (DLT), Japan Cohort C: Incidence of DLT in Japanese participant, Expansion/Optimization part (Cohorts A1, A2 & D), AML: Proportion of participants who have a CR + CRh + CRi according to the modified AML IWG 2003 criteri, Expansion/Optimization part (Cohort B), MDS: Overall response rate (CR + CR equivalent + PR + CRL + CRh + HI) according to the IWG 2023 MDS response criteria

Detailed description

Expansion/Optimization part – Cohorts A, B and D: Recommended dose for expansion (RDE), Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Number of participants with TEAEs, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Ctrough, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Incidence of ADA, Escalation and Expansion/Optimization parts – Japan Cohort C, AML: Rate of CR + CRh + CRi per AML 2003 modified IWG response criteria, Escalation and expansion/Optimization parts – Japan Cohort C, MDS: CR rate and ORR rate per IWG 2023 MDS response criteria for escalation part and ORR rate per IWG 2023, Escalation and Expansion/Optimization parts – Japan Cohort C, B-ALL: Rate of CR + CRh + CRi as defined by National Comprehensive Cancer Network (NCCN), Expansion/Optimization part – Cohorts A and D: Overall response rate (ORR), Expansion/Optimization part – Cohorts A and D: Duration of CR + CRh + CRi (Duration of CRc), Expansion/Optimization part – Cohorts A and D: Duration of CR + CRi + CRh + PR + MLFS (Duration of overall response rate), Expansion/Optimization part – Cohorts A and D: Alternative CR rate, Expansion/Optimization part – Cohorts A and D: Duration of CR + CRh (Duration of alternative CR), Expansion/Optimization part – Cohorts A and D: Event-free survival (EFS), Expansion/Optimization part – Cohorts A and D: Overall survival (OS), Expansion/Optimization part – Cohorts A and D: Rate of hematopoietic stem cell transplantation (HSCT), Expansion/Optimization part – Cohorts A and D: Time to treatment failure (TTF), Expansion/Optimization part – Cohorts A and D: Rate of conversion from transfusion dependence, Expansion/Optimization part – Cohorts A and D: Rate of participants who are transfusion independent at baseline and remain independent during 56-day postbaseline period, Expansion/Optimization part – Cohort B: Alternative CR rate, Expansion/Optimization part – Cohort B: Duration of ORR, Expansion/Optimization part – Cohort B: Eventfree survival (EFS), Expansion/Optimization part – Cohort B: Overall survival (OS), Expansion/Optimization part – Cohort B: Rate of hematopoietic stem cell transplantation (HSCT), Expansion/Optimization part – Cohort B: Time to treatment failure (TTF), Expansion/Optimization part – Cohort B: Duration of alternative CR (CR + CR equivalent + CRL + CRh), Expansion/Optimization part – Cohort B: Progression free survival (PFS)

Interventions

DRUGDIPHENHYDRAMINE
DRUGCETIRIZINE
DRUGPARACETAMOL

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Escalation Part: Incidence of dose-limiting toxicity (DLT), Japan Cohort C: Incidence of DLT in Japanese participant, Expansion/Optimization part (Cohorts A1, A2 & D), AML: Proportion of participants who have a CR + CRh + CRi according to the modified AML IWG 2003 criteri, Expansion/Optimization part (Cohort B), MDS: Overall response rate (CR + CR equivalent + PR + CRL + CRh + HI) according to the IWG 2023 MDS response criteria

Secondary

MeasureTime frame
Expansion/Optimization part – Cohorts A, B and D: Recommended dose for expansion (RDE), Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Number of participants with TEAEs, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Ctrough, Escalation and Expansion/Optimization parts – Cohorts A, B, C and D: Incidence of ADA, Escalation and Expansion/Optimization parts – Japan Cohort C, AML: Rate of CR + CRh + CRi per AML 2003 modified IWG response criteria, Escalation and expansion/Optimization parts – Japan Cohort C, MDS: CR rate and ORR rate per IWG 2023 MDS response criteria for escalation part and ORR rate per IWG 2023, Escalation and Expansion/Optimization parts – Japan Cohort C, B-ALL: Rate of CR + CRh + CRi as defined by National Comprehensive Cancer Network (NCCN), Expansion/Optimization part – Cohorts A and D: Overall response rate (ORR), Expansion/Optimization part – Cohorts A and D: Duration of CR + CRh + CRi (Duration of CRc), Expansi

Countries

France, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026