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

NCT05712278 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-09-12

No results posted yet for this study

Summary

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.

Conditions

  • Acute Myeloid Leukaemia

Interventions

DRUG

SAR445419

Cell suspension, by intraveneous (IV) injection

DRUG

fludarabine

Solution for injection , by IV injection

DRUG

cytarabine

Solution for injection, by IV injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2024-02-23
Completion
2024-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712278 on ClinicalTrials.gov