NCT02118311

Treg Cells for AGVHD in Non-myeloablative UCB Transplant

T Regulatory Cell for Suppression of Acute Graft-vs-Host-Disease in Recipients of a Non-Myeloablative Umbilical Cord Blood Transplantation for Treatment of Hematological Malignancies

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	T Regulatory cells	Fixed dose of nTreg cells will be infused on day 0 of transplant after the umbilical cord blood cells
DRUG	Fludarabine	Fludarabine 30mg/m\^2 IV over 1 hour on days -6 through -2 from transplant
DRUG	Cyclophosphamide	Cyclophosphamide 50 mg/kg IV over 2 hours on day -6 from transplant
RADIATION	Total Body Irradiation	Total Body Irradiation (TBI) 200 cGy administered on day -1 in a single fraction will be given at a dose rate of 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2014-04-21
• Last updated: 2017-12-02

Locations

1 site across 1 country: United States