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

Sanofi

Status and phase: Withdrawn; Phase 2

Conditions: Allogenic Stem Cell Transplantation

Treatments: Drug: SAR445419

Study type: Interventional

Funder types: Industry

Identifiers

NCT05726682

ACT17550

U1111-1275-1345 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

High risk AML and MDS

Experimental group

Description:

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.

Treatment:

Drug: SAR445419