James Markman, MD, PhD | Massachusetts General Hospital | Boston, MA

Sandy Feng, MD, PhD | University of California San Francisco | San Francisco, CA

Massachusetts General Hospital | Boston, MA

University of California San Francisco | San Francisco, CA

LITTMUS is comprised of two single-center, prospective, open-label, non-randomized clinical trials exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients. One of the trials will take place at Massachusetts General Hospital in Boston, MA and the other will take place at UCSF in San Fransico, CA.

The primary objective of the LITTMUS studies is to evaluate the safety and efficacy of a single IV dose of autologous, donor alloantigen-specific T regulatory cell (arTreg) product to induce operational tolerance following living or deceased donor liver transplantation.

LITTMUS will test a new approach to achieve transplant tolerance using the liver transplant recipient’s own T regulatory cells (Tregs) to produce donor alloantigen-specific Tregs. Donor alloantigen-specific Tregs are the primary investigational product in this study. Participants who successfully recieve arTregs and who successfully withdraw from immunosuppression will be closely followed for 2 years in order to monitor for any signs of transplant rejection.

You may be eligible to participate in the LITTMUS study if you:

• Are 18 years of age or older
• Are a candidate for a liver transplant
• Have not received a previous organ, tissue, or cell transplant
• Do not have active hepatitis C (HCV) or a history of Human Immunodeficiency Virus (HIV)