The efficacy and safety of ATIR (CR-AIR-004)

• Research type

  Research Study

• Full title

  An open-label, uncontrolled, multi-center, multinational study on the efficacy and safety of administration of donor lymphocytes depleted of allo-reactive T-cells (ATIR), through the use of TH9402 and light treatment in an ex vivo process, in patients receiving a CD34-selected peripheral blood stem cell graft from a related, haploidentical donor

• IRAS ID

  17896

• Contact name

  Katy/K Rezvani

• Sponsor organisation

  Kiadis Pharma Netherlands B.V.

• Eudract number

  2008-008198-73

• ISRCTN Number

  not issued

• Research summary

  For some forms of hematologic malignancies and for many relapsed hematologic malignancies allogeneic (from partially matching donor) stem cell transplantation (SCT) presents the only possibility for cure. In case no matched donor can be found in the family or in the unrelated donor bank, a haplo-identical family donor (50% match) is the only possibility. However, in a 50% mismatched donor, specific immunologic cells (T-cells) have to be depleted, as a subgroup of these T-cells will cause a condition called Graft-versus-Host-Disease (GvHD), which is fatal in many cases. Without the whole group of T-cells the patient is likely to die of infections shortly after the SCT as they do not have an immune system. With the treatment presented in this protocol, we will selectively deplete the T-cells that cause GvHD and reinfuse the remaining T-cells required for early immune reconstitution. This is done using a light-sensitive drug (TH9402) and light treatment. These modified cells are called ATIR. As a result of this treatment, the cells that defend the recipient's body against infection and fight his/her disease survive and the cells that could potentially attack the recipient's body (causing GvHD) are removed. It provides a completely new treatment option for patients for whom fairly no further treatment is available.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/39

• Date of REC Opinion

  2 Jul 2009

• REC opinion

  Further Information Favourable Opinion