Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05712278 | Terminated | Acute Myeloid Leukaemia

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

Sanofi

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.

Condition or disease

Acute Myeloid Leukaemia

Intervention/treatment

SAR445419

fludarabine

cytarabine

Phase

Phase 1

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 7 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : 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)
Actual Study Start Date : June 16, 2023
Estimated Primary Completion Date : February 23, 2024
Estimated Study Completion Date : March 12, 2024
Arm Intervention/treatment

Experimental: SAR445419

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Nebraska

University of Nebraska Medical Center Site Number : 8400003

Omaha, Nebraska, United States, 68198-2168

Not yet recruiting

United States, New York

Albert Einstein College of Medicine Site Number : 8400001

Bronx, New York, United States, 10461

Not yet recruiting

United States, Texas

~MD Anderson Cancer Center Site Number : 8400002

Houston, Texas, United States, 77030