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Safety/PK Study of Gene Modified Donor T Cell Infusion in Children With Recurrent Hem Malignancies After Allo Transplant
Sponsor: Bellicum Pharmaceuticals
Summary
Phase I, open-label, non-randomized study of safety, pharmacokinetics and efficacy of donor BPX-501 T cell infusion in children with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The study will consist of the Main Study and an optional Pharmacokinetics (PK) Sub-Study.
Official title: A Phase I Study Of Safety, Pharmacokinetics, And Efficacy Of Donor BPX-501 Cells and Rimiducid Infusion For Children With Recurrent Hematologic Malignancies or Minimal Residual Disease After Allogeneic Transplant
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2018-02-01
Completion Date
2035-09
Last Updated
2022-07-12
Healthy Volunteers
No
Conditions
Interventions
BPX-501 T cells
Biological: T cells transduced with CaspaCIDe® safety switch
rimiducid
administered to eliminate BPX-501 cells in the event of GVHD
Locations (3)
San Matteo Hospital
Pavia, Italy
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Italy
Ospedale Infantile Regina Margherita
Turin, Italy