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