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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Rambam Health Care Campus
Haifa, Israel
RECRUITINGHadassah Medical Center, Ein Kerem, Jerusalem
Jerusalem, Israel
RECRUITINGOverall incidence, frequency and severity of adverse events (AEs) potentially related to the product during the study
Time frame: 180 days from transplantation
Determination of the optimal dose of FasL concentration that facilitates the biological activity of the ApoGraft process
Time frame: 180 days from transplantation
Time of neutrophils engraftment determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3
Time frame: 28 days from transplantation
Rate of neutrophils engraftment determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3
Time frame: 28 days from transplantation
Time of platelets engraftment determined by number of days for reaching first of 3 consecutive days with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Time frame: 180 days from transplantation
Rate of platelets engraftment determined by number of days for reaching first of 3 consecutive days with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Time frame: 180 days from transplantation
Incidence to development of aGvHD
Time frame: 180 days from transplantation
Time to development of aGvHD
Time frame: 180 days from transplantation
Non-relapse mortality
Time frame: 180 days from transplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Proportion of patients with disease relapse
Time frame: 180 days from transplantation
Proportion of patients with progression free and overall survival
Time frame: 180 days from transplantation