A Phase I, Single-arm, Open Label, Dose Escalation, Multicenter Study of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

TED17749

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.

2023-06-16

2024-02-23

2024-03-12

Terminated

Early phase I

7

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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2024-04-12