Cellular Therapy for Liver Transplant Recipients
(LITTMUS-MGH Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment using special cells to help liver transplant patients stop taking anti-rejection drugs. It targets liver transplant recipients and aims to help their immune systems accept the new liver naturally. Recent studies have shown benefits of combining these special cells with minimal medication to promote acceptance and potentially regeneration.

Research Team

James F. Markmann, MD, PhD

Principal Investigator

University of Pennsylvania Medical Center: Transplantation

Eligibility Criteria

This trial is for liver transplant recipients with a positive Epstein-Barr virus test, who've completed treatment for HCV if applicable. Living donors must meet specific eligibility and manufacturing requirements. Contraception use is required, and vaccinations should be up to date. Exclusions include contraindications to certain drugs, chronic conditions that can't pause anticoagulation or immunosuppression, significant heart disease not cleared by a cardiologist, high-risk malignancies, and any factors affecting study compliance.

Inclusion Criteria

Recipient:

I understand the study and can give my consent.

Agreement to use contraception

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Exclusion Criteria

I am allergic or react badly to cyclophosphamide or Mesna.

I don't have CMV antibodies, but my donor does.

Factors potentially hampering compliance with the study protocol and follow-up visit schedule

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Treatment Details

Interventions

arTreg-CSB (Cell Therapy)
Cyclophosphamide (Chemotherapy)
Everolimus (mTOR inhibitor)
Mesna (Chemotherapy)

Trial OverviewThe trial tests cellular therapy aiming to reduce the need for immunosuppression in liver transplant patients using everolimus (a drug), arTreg-CSB (modified T cells), leukapheresis (a procedure to collect white blood cells), cyclophosphamide and mesna (chemotherapy agents). It's an open-label study at MGH where participants are openly given these interventions without randomization.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: arTreg-CSBExperimental Treatment5 Interventions

arTreg CSB: alloantigen-reactive T regulatory cells costimulatory blockade per protocol. The investigational product is donor alloantigen-specific T regulatory cells (arTreg-CSB). Supportive regimen for receipt of arTregs-CSB includes everolimus, leukapheresis, cyclophosphamide, and mesna. Participants will receive a single dose of Treg product (arTreg-CSB). The target dose is 2.5 to 125 x 10\^6 total cells. arTreg-CSB will be administered as a single peripheral intravenous (IV) infusion over approximately 15 to 30 minutes. Note: Participants who receive at least the minimum Treg product (arTreg-CSB) dose of 1 to \< 2.5 x 10\^6 cells will be included in intent-to-treat analysis.