Umbilical Cord Blood Transplant for Hematological Malignancies
Summary
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.
Timeline
- Start
- 2009-01
- Primary completion
- 2011-11
- Completion
- 2016-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells | Cell therapy | 100000 cells/kg | — |
| Subject | Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells | Cell therapy | 2e+06 cells/kg | — |
| Subject | Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells | Cell therapy | 3e+07 cells/kg | — |
| Subject | Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells | Cell therapy | 4e+08 cells/kg | — |