Treg Cells for AGVHD in Non-myeloablative UCB Transplant
Status:
Withdrawn
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
This is a Simon's optimal two-stage phase II trial designed to estimate grade II-IV acute
graft-versus-host disease (GVHD) after infusion of T regulatory (nTreg) in a fixed dose ratio
to the combined CD3+ cell count of the two graft units in recipients of double UCB
transplantation. The nTreg cells (manufactured from a 3rd cord blood unit) are infused on day
0 at least 1 hour after the 2nd unit of the double umbilical cord blood (UCB) transplant.
The nTreg cells require an 18 day (±2 days) lead time based on the planned transplant day.
The combined CD3+ cell content from the two graft UCB units is enumerated upon thaw (day 0).
The patient then receives the number of nTregs cells from the 3rd cord product to achieve a
Treg:CD3+ cells ratio of 5:1. The nTreg cell dose depends on the CD3+ cell content of the two
graft UCB graft units, but it will not exceed the highest dose level safely tested in the
ongoing University of Minnesota phase I Treg dose escalation study MT 2006-01.
Phase:
Phase 2
Details
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborators:
National Cancer Institute (NCI) National Institutes of Health (NIH)