A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

NCT ID: NCT05726682

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2027-10-11

Brief Summary

This is a multicenter, parallel multicohort, phase 2, single-arm study for adjunctive treatment in participants with high-risk myeloid malignancies undergoing allogeneic HSCT. The purpose of this study is to assess the safety and preliminary efficacy of off-the-shelf (OTS) ex vivo expanded NK cells (SAR445419) in improving relapse free survival (RFS).

Detailed Description

The expected duration of the study for a participant is about 2 years.

Conditions

Allogenic Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High risk AML and MDS

Participants with high risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic HSCT will receive 3 doses of SAR445419. A myeloablative conditioning (MAC) and a reduced intensity conditioning (RIC) cohort will be included.

Group Type: EXPERIMENTAL

SAR445419

Intervention Type: DRUG

Pharmaceutical form: cell suspension Route of administration: Intravenous (IV) injection

Interventions

SAR445419

Pharmaceutical form: cell suspension Route of administration: Intravenous (IV) injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-65 (Cohort A - MAC) or 18-75 (Cohort B - RIC)
• Participants with high-risk AML/MDS who are scheduled to undergo stem cell transplantation with matched sibling donor (MSD), matched unrelated donor (MUD) or haploidentical donor sourced HSCT
• Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) ≤ 3 (cohort A / MAC participants only)
• Adequate major non-hematopoietic organ system function
• Karnofsky performance score ≥70%
• Body weight ≥45 kg

Exclusion Criteria

• AML beyond CR1
• Presence of FLT3 mutations
• Uncontrolled bacterial, viral, or fungal infections at time of enrollment
• Positive test for human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)
• Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection
• Diagnosis of prior immunodeficiency or organ transplantation requiring immunosuppressive therapy
• Active or chronic autoimmune condition requiring systemic immunosuppressive or immunomodulatory therapy
• Prior allogeneic transplantation
• HSCT graft DSA ≥3000 MFI
• Current use of systemic corticosteroids at physiologic doses ≤ 0.2 mg/kg/day of prednisone or equivalent
• Use of checkpoint inhibitor therapy within 4 weeks prior to the start of HSCT conditioning regimen The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

U1111-1275-1345

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACT17550

Identifier Type: -

Identifier Source: org_study_id