Finding a donor remains a challenge for patients in need of an urgent hematopoietic stem cell transplantation (HSCT). The ability to obtain half matched stem cells from any family member represents a significant breakthrough in the field. Haploidentical haplo-HSCT is characterized by the nearly uniform and immediate availability of a donor and the availability of the donor for post-transplant cellular immunotherapy. However, haplo-HSCT has a high risk of Graft versus Host Disease (GvHD) and poor immune reconstitution when GvHD is prevented by all existing methods of vigorous ex vivo or in vivo T-cell depletion. Different treatment approaches are currently being explored to mitigate complications such as graft rejection, severe GvHD, and prolonged immune suppression. Novel experimental utilization of T regulatory cells, alloreactive natural killer (NK) cells, and other T cell subsets hold great promise. Cellect Biotherapeutics' platform technology, ApoGraft, is based on the findings that GvHD can be prevented by Fas receptor mediated selective depletion of T cell subsets, ex vivo. The investigators hypothesize that the use of ApoGrafts for haplo-HSCT will be safe, and reduce rates of GVHD without affecting Graft-versus-Leukemia (GvL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
ApoGraft is a cell based product, manufactured with mobilized peripheral blood.
Washington University School of Medicine
St Louis, Missouri, United States
Safety and tolerability of ApoGraft as measured by adverse events related to ApoGraft product
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Time frame: From day 0 to 1 year post-transplantation of ApoGraft product
Cumulative incidence of graft failure
-Failure to engraft will be defined as failure to achieve absolute neutrophil count \> 500 for 3 days by Day 35
Time frame: 35 days post haplo-HCT
Treatment related mortality
-Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.
Time frame: Through 1 year post-transplantation of ApoGraft product
Time of neutrophil engraftment as determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3
Time frame: 35 days post haplo-HCT
Rate of neutrophil engraftment as determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3
Time frame: 35 days post haplo-HCT
Time of platelet engraftment determined by number of days for reaching first measurement of 3 consecutive measurements with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Time frame: 35 days post haplo-HCT
Rate of platelet engraftment determined by number of days for reaching first measurement of 3 consecutive measurements with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Time frame: 35 days post haplo-HCT
Incidence of Grade 2-4 acute GVHD
-Acute GVHD will be assessed using MAGIC criteria
Time frame: Day 180
Time to development of Grade 2-4 acute GVHD
-Acute GVHD will be assessed using MAGIC criteria
Time frame: Day 180
Incidence of Grade 3-4 acute GVHD
-Acute GVHD will be assessed using MAGIC criteria
Time frame: Day 180
Time to development of Grade 3-4 acute GVHD
-Acute GVHD will be assessed using MAGIC criteria
Time frame: Day 180
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