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

Trial Profile

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

Completed
Phase of Trial: Phase II

Latest Information Update: 28 Mar 2018

At a glance

  • Drugs T cell replacement therapy TH 9402 (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Kiadis Pharma
  • Most Recent Events

    • 28 Mar 2018 According to a Kiadis Pharma media release, company has submitted all the Day 120 List of Questions for its lead product ATIR101 to the European Medicines Agency's (EMA) within the timeline. company expects to obtain a positive CHMP opinion for ATIR101 in Q4 2018 and (conditional) approval from the European Commission in Q1 2019 and launch in H2 2019.
    • 12 Mar 2018 According to a Kiadis Pharma media release, the company is on track for potential (conditional) Marketing Authorization Application (MAA) approval in Q4 2018 and launch in H2 2019.
    • 16 Nov 2017 Status changed from active, no longer recruiting to completed.
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