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SAR445419

A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia

Ensayo de Sanofi en Acute Myeloid Leukaemia (del registro, en inglés).

Fase

Fase 1

Estado

Interrumpido

Participantes

7

previstos

Centros

3

Fin del objetivo primario

feb 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jun 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor's decision».

Qué mide

Incidence of dose-limiting (DLT) toxicity (from Day 1 to Day 28) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and cytarabine conditioning for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). Adult participants with R/R AML will be eligible for treatment. The study is intended to assess the candidate dose(s) by the occurrence of dose-limiting toxicity (DLT) from start of chemotherapy until 28 days after the first administration of SAR445419. The duration of the study for a participant will include: * Screening period up to 21 days prior to initiating chemotherapy, * Treatment period of 5 days chemotherapy followed by SAR445419 administered for 2 weeks and end of treatment visit 56 days after first SAR445419 administration, * Survival follow-up period up to 1 year after the last participant has started treatment with SAR445419.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05712278), actualizada en jun 2026.