CR-AIR-007
Research type
Research Study
Full title
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
IRAS ID
169241
Contact name
Eduardo Olavarria
Contact email
Sponsor organisation
Kiadis Pharma Netherlands B.V.
Eudract number
2012-004461-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
The study is being conducted to investigate if it is safe and effective to give a preparation of white blood cells from a
family donor whose cells do not fully match the patient’s, 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 ATIR.
Patients and familydonors
will first be screened to see whether they are eligible for the study. When a donorpatient
pair is found to be eligible for the study both will undergo a procedure, called apheresis, to collect white blood cells for
ATIR 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.
ATIR will be administered to the patient as a single infusion into the blood stream about 4 weeks after the bone
marrow transplantation. Assessments will be performed at weekly visits from the day of ATIR infusion until 8 weeks
after ATIR infusion, at monthly visits from 3 until 6 months after the bone marrow transplantation, every 2 months from 6
until 12 months after the bone marrow transplantation, and every 6 months from 12 until 24 months after the bone marrow transplantation.
The aim of the study is to assess the safety of ATIR (none, or an acceptable rate of GvHD) and efficacy of ATIR (less
infections and relapses after the transplantation procedure and therefore, increased chances to survive)REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0585
Date of REC Opinion
21 Nov 2017
REC opinion
Favourable Opinion