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

NCT05726682

WithdrawnPhase 2

Sponsor: Sanofi

Conditions: Allogenic Stem Cell Transplantation

Interventions: SAR445419

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.