Prevention of Acute Graft Versus Host Disease in Patients Undergoing Allogeneic ApoGraft Stem Cell Transplantation

Phase 1

• Conditions: Hematological Malignancies
• Interventions: Biological: Allogeneic MPBC transplantation from matched related donor

• Registration Number: NCT02828878
• Lead Sponsor: Cellect Biotechnology

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Study Start: 2017-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-24
• Last Update Posted: 2019-11-26
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ApoGraft	Allogeneic MPBC transplantation from matched related donor	ApoGraft is a mobilized peripheral blood cell (MPBC) product derived from peripheral blood. There will be 4 cohorts, each differ in the amount of apoptotic mediator Fas Ligand (APO010) to which the graft is exposed during incubation prior to ApoGraft transplant, 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

Primary Outcome Measures

Name	Time	Method
Overall incidence, frequency and severity of adverse events (AEs) potentially related to the product during the study	180 days from transplantation

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with progression free and overall survival	180 days from transplantation
Determination of the optimal dose of FasL concentration that facilitates the biological activity of the ApoGraft process	180 days from transplantation
Time of neutrophils engraftment determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3	28 days from transplantation
Rate of neutrophils engraftment determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3	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	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	180 days from transplantation
Incidence to development of aGvHD	180 days from transplantation
Time to development of aGvHD	180 days from transplantation
Non-relapse mortality	180 days from transplantation
Proportion of patients with disease relapse	180 days from transplantation

Trial Locations

Locations (2)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Hadassah Medical Center, Ein Kerem, Jerusalem; 🇮🇱 Jerusalem, Israel