A Phase 1/2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells After Partially Mismatched, Related, T Cell-Depleted HSCT (Hematopoietic Stem Cell Transplant)
This is a Phase1/2 dose escalation study evaluating the safety and feasibility of BPX-501
infused after partially mismatched, related (haploidentical), T cell-depleted HSCT. The
purpose of this clinical trial is to determine whether BPX-501 infusion can facilitate
engraftment, enhance immune reconstitution and potentially improve the graft versus leukemia
(GVL) effect, with the potential for reducing the severity and duration of severe acute
graft versus host disease (GvHD). The trial will evaluate the treatment of GvHD by the
infusion of dimerizer drug (AP1903) in those subjects who present with severe GvHD (Grades
III and IV) as well as those subjects with Grade I and II who progress or do not respond to
corticosteroid therapy within 4 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
BPX-501 dose that produces no more than 45% Grade II-IV aGVHD and no more than 17% Grade III-IV aGvHD
To determine the maximum dose of BPX-501 cells (up to 5 x 10E6 cells/kg) which results in an adjusted cumulative incidence by day 100 of no more than 45% Grade II-IV aGVHD and nor more than 17% Grade III-IV aGvHD. Adjusted cumulative incidence is the total aGvHD cumulative incidence minus the AP1903 GvHD response.
Hillard Lazarus, M.D.
University Hospitals of Cleveland
United States: Food and Drug Administration
|University Hospitals of Cleveland||Cleveland, Ohio 44106|
|Baylor Charles A Sammons Cancer Center||Dallas, Texas 75246|