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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Nov 2019

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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

    • 06 Nov 2019 According to a Kiadis Pharma media release, new ATIR101 data will be discussed in an oral presentation exploring the effect of a single infusion of ATIR101 on survival outcomes in patients with blood cancer who underwent T-cell depleted haploidentical-hematopoietic stem cell transplantation (haplo-HSCT) from a pooled analysis of two Phase II trials (CR-AIR-007, NCT01794299; CR-AIR-008, NCT02500550) at the 59th Annual Meeting of the American Society of Hematology (ASH).
    • 28 Jun 2019 According to a Kiadis Pharma media release, the European Medicines Agency informed Kiadis that it will convene a Scientific Advisory Group (SAG) in September to assist EMA in arriving at a determination. With the SAG meeting now preceding the subsequent CAT and CHMP meetings as part of the EMA approval process, the company is changing its guidance to potential EU conditional approval in 2020.
    • 28 Jun 2019 According to a Kiadis Pharma media release, the company has received feedback from the European Medicines Agency (EMA) related to the marketing authorization application (MAA) seeking approval of ATIR101 in hematopoietic stem cell transplant.
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