Clinical trial

A Phase 2, Single Arm, Multicohort, Open Label, Multicenter Trial of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Patients With High-risk Myeloid Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Name

ACT17550

Description

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).

Trial arms

Trial start

2024-10-08

Estimated PCD

2027-02-12

Trial end

2027-10-11

Status

Withdrawn

Phase

Early phase I

Treatment

SAR445419

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

Arms:

High risk AML and MDS

Primary endpoint

Rate of relapse free survival (RFS) post allogeneic hematopoietic stem cell transplantation (HSCT)

12 months post HSCT

Frequency of cytomegalovirus (CMV) reactivation/infection in CMV seronegative participants who receive a CMV seronegative HSCT graft

From baseline up to 2 years

Frequency of life-threatening (grade 4) infusion related reactions (IRR) or cytokine release syndrome (CRS) that does not resolve to grade 1 within 72 hours despite therapy

From baseline up to 2 years

Frequency of life threatening (grade 4) tumor lysis syndrome (TLS)

From baseline up to 2 years

Frequency of life-threatening (grade 4) immune cell-associated neurotoxicity syndrome (ICANS) that does not resolve to grade 1 within 72 hours despite therapy

From baseline up to 2 years

Frequency of grade 3-4 acute graft versus host disease (aGVHD)

From baseline up to 2 years

Frequency of non-relapse mortality (NRM)

100 days post HSCT

Frequency of graft failure

100 days post HSCT

Frequency of overall mortality

100 days post HSCT

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel multicohort, phase 2, single-arm study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-03-05

1 organization

1 product

1 indication

Organization

Sanofi

Product

SAR445419

Indication

Allogeneic Stem Cell Transplantation