An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of ATIR, Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 26 Apr 2017
At a glance
- Drugs T cell replacement therapy TH 9402 (Primary)
- Indications Graft-versus-host disease
- Focus Registrational; Therapeutic Use
- Sponsors Kiadis Pharma
- 26 Apr 2017 According to a Kiadis Pharma media release, the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ATIR101™ as an adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for malignant disease. The application is based on data from this trial.
- 13 Mar 2017 Data will be presented at the International Society for Cellular Therapy (ISCT) 2017 Annual Meeting, according to a Kiadis Pharma media release.
- 11 Dec 2016 Planned End Date changed from 1 Oct 2016 to 1 Oct 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History