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: 27 Sep 2017
At a glance
- Drugs T cell replacement therapy TH 9402 (Primary)
- Indications Graft-versus-host disease
- Focus Registrational; Therapeutic Use
- Sponsors Kiadis Pharma
- 27 Sep 2017 According to a Kiadis Pharma media release,the company has received and reviewed the Day 120 List of Questions (LoQs) for its lead product ATIR101 from the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT). The company expects that it will be able to address all questions within the six months response time that has been agreed with EMA.
- 19 Sep 2017 According to a Kiadis Pharma media release, results from this trial were presented at the 4th Cell and Gene Therapy Conference.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History