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

NCT05712278 | Terminated Phase 1 FDA Drug

• 2 other identifiers: TED17749U1111-1279-2948
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting (DLT) toxicity

  from Day 1 to Day 28

• Incidence of DLT from start of chemotherapy

  From Day -6 to Day 28

Secondary Outcomes (13)

• Number of participants with adverse events (AEs)

  From baseline up to 1 year

• Median time to neutrophil and platelet count recovery

  From Day -6 up to 1 year

• Rate of HSCT

  From baseline up to 1 year

• Number of participants with infection

  From baseline up to 1 year

• Number of participants by type of infection

  From baseline up to 1 year

Study Arms (1)

SAR445419

EXPERIMENTAL

Treatment consists of chemotherapy with fludarabine 30mg/m2/day and cytarabine 2g/m2/day administered for 5 days (Day -6 to Day -2), followed by 6 doses of SAR445419 given thrice weekly for 2 weeks beginning Day 1.

Drug: SAR445419; Drug: fludarabine; Drug: cytarabine

Interventions

SAR445419 DRUG

Cell suspension, by intraveneous (IV) injection

SAR445419

fludarabine DRUG

Solution for injection , by IV injection

Also known as: fludara

SAR445419

cytarabine DRUG

Solution for injection, by IV injection

Also known as: cytosar-U

SAR445419

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 years of age inclusive
• Participants with confirmed diagnosis of relapsed or primary refractory acute myeloid leukemia (AML), according to World Health Organization (WHO) classification, including:
• Participants with relapsed AML after allogeneic stem cells transplantation, including those who have received donor lymphocyte infusions,
• Isolated central nervous system (CNS) or extramedullary disease,
• At least 1 prior line of therapy which includes chemotherapy, hypomethylating agents, venetoclax or targeted therapy.
• Participants with a weight ≥42 kg.

You may not qualify if:

• Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
• Known acquired immunodeficiency syndrome (AIDS-related illnesses) or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or having active hepatitis B or C infection, or symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
• Pregnant or breast-feeding women, female participants of childbearing potential, and male participants with female partners of childbearing potential who are not willing to avoid pregnancy by using a highly effective method of contraception (2 barrier method or 1 barrier method with a spermicide, intrauterine device, or hormonal contraception with inhibition of ovulation, for 2 weeks prior to the first dose of SAR445419, during treatment, and 6 months after the last dose of fludarabine). A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile.
• History of solid organ transplant, including corneal transplant.
• Receiving at the time of first SAR445419 administration corticosteroid as a concomitant medication with corticosteroid dose \>10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray, or ophthalmic solution
• Known contraindication to any of the non-investigational medicinal products (NIMPs) (fludarabine, cytarabine, acetaminophen and diphenhydramine).
• Concurrent treatment with other investigational drugs
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

University of Nebraska Medical Center Site Number : 8400003

Omaha, Nebraska, 68198-2168, United States

Location

Albert Einstein College of Medicine Site Number : 8400001

The Bronx, New York, 10461, United States

Location

~MD Anderson Cancer Center Site Number : 8400002

Houston, Texas, 77030, United States

Location

Related Links

• TED17749 Plain Language Results Summary

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabine; fludarabine phosphate; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 3, 2023
• Study Start: June 16, 2023
• Primary Completion: February 23, 2024
• Study Completion: March 12, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3)