NCT02526329

Donor Regulatory T Cells in Treating Patients With Visceral Acute Graft-versus-Host Disease After Stem Cell Transplant

A Phase 1 Single Center Safety and Feasibility Study of Primary T Regulatory Cell Therapy to Treat Visceral Acute Graft-versus-Host Disease Following Hematopoietic Cell Transplantation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Everett Meyer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	donor regulatory T lymphocytes	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-08-06
• Primary completion: 2022-11-01
• Completion: 2023-06-01
• First posted: 2015-08-18
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study