For Healthcare Professionals

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

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About the study

This 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.
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Study Locations

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How to Apply


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Study’s details


Contition

Acute Myeloid Leukaemia

Age (in years)

18+

Phase

Phase 1

Participants needed

12

Est. Completion Date

Feb 21, 2025

Treatment type

Interventional


Sponsor

Sanofi

ClinicalTrials.gov identifier

NCT05712278

Study number

TED17749

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