Hematological Malignancies Clinical Trial
Official title:
An Open-Label Phase I/II, Pilot, Staggered Four-Cohort Safety and Proof-of-Concept Study of ApoGraft in the Prevention of Acute Graft Versus Host Disease (aGvHD)
Interventional, open label, Phase I/II, Safety and Proof-of-Concept Study, with a follow up period of 180 days after the transplantation of ApoGraft.
ApoGraft product is a mobilized peripheral blood cell product of a matched Related donor,
collected via apheresis, which is exposed to the apoptotic mediator Fas Ligand (CD95L) prior
to transplantation (Ex Vivo).
The study is designed to address the aspects of engraftment and Prevention of Acute Graft
versus Host Disease (aGvHD) rate and/or severity in 12 Patients
STUDY DESIGN:
This is a phase 1/2, open-label, proof-of-concept, staggered 4-cohort clinical study. Each
cohort will include 3 patients with hemato-oncology disorders eligible for allogeneic
HLA-matched HSCT. Patients in all cohorts will undergo similar study procedures and
evaluation. The cohorts will differ from each other in the amount of apoptotic mediator Fas
Ligand (APO010) to which the graft is exposed during incubation prior to ApoGraft
transplantation and HSCT, ranging from 10 ng/ml APO010 in Cohort 1, 25 ng/ml APO010 in Cohort
2, 50 ng/ml APO010 in Cohort 3 and 100 ng/ml APO010 in Cohort 4. APO010 is washed-out as part
of the ApoGraft process and only trace amounts of APO010 are present in the final ApoGraft
product
The study consists of a screening phase (subject and donor clinical assessment and screening
tests), transplantation of ApoGraft, and a follow-up period of 180 days during and after
hospitalization.
The study will progress from one cohort to the next based on an independent data safety
monitoring board (DSMB) review and analysis of safety data
;
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