An exploratory, open-label study to evaluate the safety and feasibility of ATIR201, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), as adjuvant treatment to a T-cell depleted haploidentical hematopoietic stem cell transplantation in patients with beta-thalassemia major

Trial Profile

An exploratory, open-label study to evaluate the safety and feasibility of ATIR201, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), as adjuvant treatment to a T-cell depleted haploidentical hematopoietic stem cell transplantation in patients with beta-thalassemia major

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 03 Apr 2017

At a glance

  • Drugs ATIR 201 (Primary)
  • Indications Thalassaemia
  • Focus Adverse reactions; First in man
  • Sponsors Kiadis Pharma
  • Most Recent Events

    • 03 Apr 2017 According to a Kiadis Pharma media release, the company has received regulatory approval from the national authority in Germany to initiate this phase I/II study in Germany.
    • 16 Mar 2017 According to a Kiadis Pharma media release, trial design will be presented at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).
    • 13 Mar 2017 According to a Kiadis Pharma media release, status changed from planning to recruiting.
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