Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention
Status:
Completed
Trial end date:
2020-10-06
Target enrollment:
Participant gender:
Summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential
participant.
T-cells are white blood cells that are important to the immune system. The T cells for this
study (called regulatory T-cells, or Tregs) will be from a donor who is not related to you.
Before the Tregs are given to you, they may be changed in the laboratory to make use of sugar
that is found in small amounts in blood cells through a process called fucosylation. They are
then called fucosylated Tregs. Adding more sugars to the Tregs in the laboratory is designed
to help the Tregs find their way faster to the bone marrow, which may help low blood counts
to recover faster.
The goal of this clinical research study is to learn if it is safe and practical to give
fucosylated Tregs to patients who will receive a matched related donor (MRD), a matched
unrelated donor (MUD), or cord blood transplant. Researchers also want to learn if these
Tregs may prevent or reduce the effects of graft-versus host disease (GVHD). GVHD can result
from a reaction of the transplanted cord blood cells against certain tissues in the body.
This is an investigational study. Fucosylation of Tregs is not an FDA-approved process. It is
currently being used for research purposes only. Fludarabine, melphalan, cyclophosphamide and
rituximab are FDA approved and commercially available to be given to patients with leukemia
or lymphoma having a cord blood transplant. Total body irradiation is delivered using
FDA-approved and commercially available methods.
Up to 47 patients will take part in this study. All will be enrolled at MD Anderson.
Phase:
Phase 1
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Cancer Prevention Research Institute of Texas National Cancer Institute (NCI) Targazyme, Inc.