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Cell Therapy

arTreg for Liver Transplant (LITTMUS-UCSF Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of enrollment through completion of study participation (up to 1.8 years)
Awards & highlights

LITTMUS-UCSF Trial Summary

This trial is exploring whether a cell therapy can help people with liver transplants stop taking immunosuppressive drugs.

LITTMUS-UCSF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of enrollment through completion of study participation (up to 1.8 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of enrollment through completion of study participation (up to 1.8 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and Severity of Adverse Events (AEs) Attributed to Supportive Regimen: Leukapheresis, Cyclophosphamide or Mesna
Investigational New Drugs
Number of Operationally Tolerant Participants
Secondary outcome measures
Duration of Operational Tolerance
Incidence of ≥Grade 3 Infections Following arTreg Infusion
Number of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at Any Time After Alloantigen-Reactive Tregs (arTreg) Infusion
+4 more

LITTMUS-UCSF Trial Design

1Treatment groups
Experimental Treatment
Group I: arTregExperimental Treatment5 Interventions
arTreg: alloantigen-reactive T regulatory cells The investigational product is donor alloantigen-reactive regulatory T cells (arTreg). Supportive regimen for receipt of arTregs includes everolimus, leukapheresis, cyclophosphamide, and mesna. Note: Participants who receive at least the minimum Treg product (arTreg) dose of 30 to <90 x10^6 total cells will be included in intent-to-treat analysis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
leukapheresis
2004
Completed Phase 3
~230
Everolimus
FDA approved
Coenzyme M
FDA approved

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,277 Previous Clinical Trials
5,487,411 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
41 Previous Clinical Trials
13,579 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,947 Total Patients Enrolled
~10 spots leftby Jun 2025