A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor cells (HSPC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Human leukocyte antigen (HLA) matched umbilical cord blood
Expanded cord blood stem cells and engineered human endothelial cells
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of Colorado Cancer Center University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4
Time frame: 24 hours
Graft failure defined as survival to day 42 without absolute neutrophil count greater than or equal to 500/mm3
Time frame: 42 days
Time to neutrophil engraftment
Time frame: 42 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Time frame: 42 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Time frame: 100 days
Cumulative incidence of sustained donor-derived neutrophil engraftment
Time frame: 180 days
Incidence of engraftment syndrome
Time frame: 28 days
Cumulative incidence of graft failure
Time frame: 43 days
Cumulative incidence of graft failure
Time frame: 180 days
Presence of post-transplant phenotype in hematopoietic cells of donor origin
Time frame: 180 days
Cumulative incidence of grade II - IV acute graft versus host disease (aGVHD)
Time frame: 100 days
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Cumulative incidence of grade II - IV acute graft versus host disease (GVHD)
Time frame: 180 days
Cumulative incidence of chronic GVHD
Time frame: 100 days
Cumulative incidence of chronic GVHD
Time frame: 180 days
Time to lymphoid recovery
Time frame: 180 days
Cumulative incidence of transplant related mortality (TRM)
Time frame: 100 days
Cumulative incidence of transplant related mortality (TRM)
Time frame: 180 days
Overall survival (OS)
Time frame: 100 days
Overall survival (OS)
Time frame: 180 days
Disease Free Survival (DFS)
Time frame: 100 days
Disease Free Survival (DFS)
Time frame: 180 days