A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
Investigational Medication for Relapsed or Refractory Acute Myeloid Leukemia
Study Overview
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 Details
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Myeloid Leukaemia
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Age: 18 years or above
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Gender: All
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.
This study investigates the effects of an investigational medication given after specific chemotherapy drugs, fludarabine and cytarabine, for treating adults with relapsed or refractory acute myeloid leukemia (AML). Acute myeloid leukemia is a type of cancer that affects the blood and bone marrow. The study aims to find the right dose of the investigational medication by observing any dose-limiting toxicities, which are side effects that prevent a dose increase.
Participants will receive chemotherapy for 5 days, followed by the investigational medication for 2 weeks. The study includes a screening period, treatment, and follow-up visits. Researchers will monitor participants for safety and any anti-tumor activity of the medication. Participants will be checked for side effects and other health changes during and after treatment.
- Who can participate: Adults aged 18 and older with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia can participate. They must have previously received at least one line of therapy, weigh at least 42 kg, and meet other health criteria.
- Study details: Participants will undergo a screening period, followed by 5 days of chemotherapy and 2 weeks of the investigational medication. A placebo is not used in this study. Participants will be monitored closely for any side effects and their response to treatment.
- Study Timelines: The study will last 1 year.