A Phase 1 Dose Escalation Study of Infusion of ex Vivo cd3/cd28 Costimulated Umbilical Cord Blood-derived t Cells in Adults Undergoing Transplantation for Advanced Hematologic Malignancies
The main study intervention includes CD3/CD28 ex vivo costimulated T cells derived from a
thawed umbilical cord blood unit, co-infused following a myeloablative conditioning regimen.
Activated T cells are T cells that have been activated in the laboratory by exposure to 2
compounds or molecules called CD3 and CD28; when T cells are exposed to both of these
compounds at the same time, they become activated or "stimulated" and may be more effective
in fighting infections, cancer cells, and promoting the recovery of red cells, white cells,
and platelets after transplantation. At the Hospital of the University of Pennsylvania,
activated T cells are prepared at the Clinical Cell and Vaccine Production Facility, also
known as the CVPF.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicity (DLT) is defined as grade 4 acute GVHD within the first 90 days following infusion.
90 Days post Transplant
David Porter, MD
University of Pennsylvania
United States: Food and Drug Administration
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