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

  • STATUS
    Recruiting
  • participants needed
    12
  • sponsor
    Sanofi
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Updated on 3 December 2024
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Accepts healthy volunteers

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.

Description

Participants will be followed for 28 days (for DLT evaluations) after administration of the first SAR445419 dose (Day 1) for the primary endpoint and for 1 year after the first SAR445419 dose for selected secondary endpoints.

Details
Condition Acute Myeloid Leukaemia
Age 18years or above
Treatment cytarabine, Fludarabine, SAR445419
Clinical Study IdentifierNCT05712278
SponsorSanofi
Last Modified on3 December 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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