25
Participants
Start Date
November 30, 2013
Primary Completion Date
August 31, 2017
Study Completion Date
December 31, 2025
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
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).
Brigham and Women's Hospital, Boston
Dana-Farber Cancer Insitute, Boston
Collaborators (2)
Miltenyi Biomedicine GmbH
INDUSTRY
Iovance Biotherapeutics, Inc.
INDUSTRY
National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER