CR-AIR-008
Research type
Research Study
Full title
An exploratory, open-label, multicenter study to evaluate the safety and efficacy of a two-dose regimen of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor
IRAS ID
189344
Contact name
Annelies Legters
Contact email
Sponsor organisation
Kiadis Pharma Netherlands BV
Eudract number
2015-002821-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
The study is being conducted to investigate if it is safe and effective to give a repeated dose of a preparation of white blood cells from a family donor whose cells do not fully match the patients', in addition to the bone marrow transplantation, which patients often undergo for blood cancer (leukemia). These donor cells are treated in the laboratory to take out those white blood cells which could attack the patient’s body and cause a condition called graft versus host disease (GvHD). This preparation of white blood cells is called ATIR101.
Patients and family-donors will first be screened to see whether they are eligible for the study. When a donor-patient pair is found to be eligible for the study both will undergo a procedure, called apheresis, to collect white blood cells for ATIR101 manufacturing. Additionally, stem cells will be collected from the donor for the bone marrow transplantation. In parallel, before the transplantation, the patient will be treated with extensive chemotherapy and irradiation.
ATIR101 will be administered twice to the patient, the first dose will be infused into the blood stream about 4 weeks after the bone marrow transplantation and the second dose will be infused about 6 weeks later. After the transplantation, weekly assessments will be performed until 16 weeks after the transplantation, monthly assessments will be performed up to 6 months after the transplantation, and every 3 months up to 12 months after the bone marrow transplantation.
The aim of the study is to assess the safety (none, or an acceptable rate of GvHD) and efficacy (less infections and relapses after the transplantation procedure and therefore, increased chances to survive) of ATIR101 when administered as repeat dose.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0584
Date of REC Opinion
21 Nov 2017
REC opinion
Favourable Opinion