Multiple Myeloma Clinical Trial
Official title:
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
This protocol will enroll subjects with advanced hematologic malignancies who do not have a
suitable related or unrelated donor to undergo a Stem Cell Transplant.
In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the
cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent
to a laboratory in order to grow the T cells (from the cord blood) and increase the activity
of the cord blood T cells.
The purpose of this part of the study is to see if it is safe to give study subjects
activated T cells made from a small portion of their donor UCB unit immediately after the
UCB transplant. Activated T cells have been used safely in stem cell transplantation studies
in the past, but they have never been studied UCB transplantation.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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