NCT05726682

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

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	SAR445419	Pharmaceutical form: cell suspension Route of administration: Intravenous (IV) injection

Timeline

• Start date: 2024-10-08
• Primary completion: 2027-02-12
• Completion: 2027-10-11
• First posted: 2023-02-14
• Last updated: 2024-03-05

Regulatory

• FDA-regulated drug study