Umbilical Cord Blood Transplant for Hematological Malignancies (UCB)
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.
|CML AML MDS ALL NHL Multiple Myeloma Hodgkin's Disease||Biological: Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells Other: Observation Arm||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Dose limiting toxicity (DLT) is defined as grade 4 acute GVHD within the first 90 days following infusion. [ Time Frame: 90 Days post Transplant ]
|Study Start Date:||January 2009|
|Study Completion Date:||May 2016|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Dose Escalation Arm
Subjects with cord blood stored in more than one fraction will be enrolled into Dose Escalation Arm. Subjects will receive Cord Blood Stem Cell Transplant followed by expanded Cord Blood T cells on Day 0.
Biological: Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells
Single infusion of Cord Blood Cells AND Single Infusion of ex vivo CD3/CD28 costimulated Umbilical Cord Blood T cells.
Table 6: Dose escalation (Dose level CD3+ cell dose)
Active Comparator: Observation Arm
Subjects with cord blood stored in one fraction will be enrolled into the Observation Arm. Subjects will receive Cord Blood Stem Cell Transplant on Day 0.
Other: Observation Arm
Single infusion of Cord Blood Cells
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891592
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||David Porter, MD||University of Pennsylvania|
|Principal Investigator:||Elizabeth Hexner, MD||University of Pennsylvania|