Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

Phase 1/2 Completed 19 enrolled Kiadis Pharma

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related, haploidentical donor, in patients with severe hematologic malignancies.

Timeline

Start: 2005-01
Primary completion: 2008-10
Completion: 2013-04

Publications

Roy DC, Lachance S, Cohen S, Delisle JS, Kiss T, Sauvageau G, Busque L, Ahmad I, Bernard L, Bambace N, Boumedine RS, Guertin MC, Rezvani K, Mielke S, Perreault C, Roy J. Allodepleted T-cell immunotherapy after haploidentical haematopoietic stem cell transplantation without severe acute graft-versus-host disease (GVHD) in the absence of GVHD prophylaxis. Br J Haematol. 2019 Sep;186(5):754-766. doi: 10.1111/bjh.15970. Epub 2019 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ATIR101	Cell therapy	10000 cells/kg	Intravenous
Subject	ATIR101	Cell therapy	50000 cells/kg	Intravenous
Subject	ATIR101	Cell therapy	130000 cells/kg	Intravenous
Subject	ATIR101	Cell therapy	320000 cells/kg	Intravenous
Subject	ATIR101	Cell therapy	790000 cells/kg	Intravenous
Subject	ATIR101	Cell therapy	2e+06 cells/kg	Intravenous
Subject	ATIR101	Cell therapy	5e+06 cells/kg	Intravenous

Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

Summary

Timeline

Publications

Drugs

Indications