This phase I trial studies the side effects and best dose of donor regulatory T cells in treating patients with graft-versus-host disease affecting the liver or gastrointestinal organs (visceral) within 100 days (acute) after undergoing a stem cell transplant. Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a type of immune cell that may be able to reduce the attack of the donor’s immune cells on the patient’s normal cells and help treat graft-vs-host disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02526329.
PRIMARY OBJECTIVES:
I. Determine the safety and feasibility of donor T regulatory (Treg) cell infusions in subjects with visceral acute graft-versus-host disease (aGVHD) and incidence of dose limiting toxicities (DLTs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE version 4 [v.4]) with a focus on infusion reactions within 24 hours, respiratory distress within 72 hours of infusion and all-cause mortality within 28 days of infusion.
SECONDARY OBJECTIVES:
I. Determine the quantitative blood Treg cell changes following the cell infusions.
II. Assess dosing requirements and treatment response rates to primary steroid, secondary and tertiary immunosuppressive therapy.
III. Post-transplant day +100 and day +180 survival.
IV. Post-transplant incidence of chronic graft-versus-host disease (GVHD) at day +180.
OUTLINE: This is a dose-escalation study.
Patients receive donor regulatory T lymphocytes intravenously (IV) over 5 minutes or less on day 0. Some patients receive a second infusion of frozen donor regulatory T lymphocytes 5-7 days after the initial infusion or 2 additional infusions separated by 5-7 days.
After completion of study treatment, patients are followed up weekly until day 28 and then on days 100 and 180.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorEverett Meyer
