Trial of Regulatory T-cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

August 31, 2017

Study Completion Date

December 31, 2025

Conditions
Chronic Graft Versus Host DiseaseChronic GVHDComplications of Organ Transplant Stem Cells
Interventions
OTHER

Treg-enriched infusion

Treg-enriched Cell Dose: Participants will be targeted to a defined dose of donor Treg-enriched total nucleated cells. Initial enrollment will be at target dose-level A. Subsequent cohorts will be dose escalated/de-escalated per the schema

DRUG

Interleukin-2

Interleukin-2: Starting the day of Treg-enriched cell infusion, each participant will receive daily subcutaneous IL-2 for self-administration for 8 weeks, followed by a 4-week hiatus. IL-2 will be administered on an outpatient basis. Expected toxicities and potential risks as well as dose modifications are described in Section 6 (Expected Toxicities and Dosing Delays/Dose Modification).

Trial Locations (2)

02215

Brigham and Women's Hospital, Boston

Dana-Farber Cancer Insitute, Boston

All Listed Sponsors
collaborator

Miltenyi Biomedicine GmbH

INDUSTRY

collaborator

Iovance Biotherapeutics, Inc.

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Dana-Farber Cancer Institute

OTHER