A Phase I Study of CD8 Memory T-Cell Donor Lymphocyte Infusion for Relapse of Hematolymphoid Malignancies Following Matched Related Donor Allogeneic Hematopoietic Cell Transplantation
I. To determine the feasibility of purifying allogeneic CD8+ memory T-cells suitable for
clinical application and to determine the safety and maximum tolerated dose (MTD) of these
cells in patients with recurrent or refractory hematolymphoid malignancies following
allogeneic hematopoietic cell transplant (HCT).
I. To determine disease response, time to disease progression, event-free survival, and
overall survival following treatment with allogeneic CD8+ memory T-cells.
II. To assess donor specific chimerism before and at designated time points after treatment
with allogeneic CD8+ memory T-cells.
OUTLINE: This is a dose-escalation study.
Patients undergo CD8+ memory T-cell infusion over 10-20 minutes.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurence (individual listings and summary) of dose-limiting toxicities
60 days following CD8+ memory T-cell infusion
United States: Food and Drug Administration
|Stanford University||Stanford, California 94305|