Acute Myeloid Leukemia Clinical Trial
Official title:
Optimization of the T Regulatory Cell and T Effector Cell Doses in Recipients of Double UCB Transplantation for Treatment of Hematological Malignancies
This is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB)
Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible
without conferring grade II-IV acute graft-versus-host disease (GVHD).
In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two
TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible
without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit
the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell
recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged
pharmacologic immunosuppression.
Based on prior studies, the first patient will start at lowest dose combination (3 x 10^6/kg
of Treg and 3 x 10^6/kg of CD3+ Teff cells).
One patient will be entered at each level with a minimum of 35 days to observe the patient
prior to moving to the next dose level. (1) If GVHD does not occur, a "successful step", then
the CD3+ Teff cell dose will increase to the next higher level for the next patient; (2) If
GVHD occurs, a "failed step", then Treg dose will increase to the next higher level for the
next patient. It would take a minimum of 5 (if no GVHD) and maximum of 9 patients (if GVHD is
observed at each level) to complete all Treg:CD3+ Teff cell combinations.
An additional 10 patients will be enrolled to verify that this reflects the optimal
combination and evaluate its safety profile.
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