NCT06455280 A Study of SIPLIZUMAB in AILD and LT Patients
| NCT ID | NCT06455280 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Elizabeth C. Verna |
| Condition | Autoimmune Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2024-09-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT. Up to eight (8) subjects will receive siplizumab 0.6 mg/kg/dose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses. All subjects will be followed in the study for 12 months post-LT.
Eligibility Criteria
Inclusion Criteria: 1. Able to provide informed consent 2. Age ≥ 18 years old 3. Clinical diagnosis of AIH and/or PSC 4. Listed for liver transplantation 5. Epstein-Barr virus (EBV) seropositive within 12 months of screening Exclusion Criteria: 1. Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven non-alcoholic steatohepatitis 2. Prior transplant 3. Listed for multiorgan transplant 4. Acute liver failure 5. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma 6. Other investigational products in the last 30 days or 5 half lives 7. Pregnant/lactating or unwilling to use contraception 8. Leukopenia (WBC less than 2,000/mm3 9. Absolute lymphocyte count \< 200/mm3 10. Sero-positive for HIV-1 11. Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening) 12. HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening) 13. Alcohol use exceeding 30g/day for men or 20g/day for women, and/or known phosphatidylethanol (PETH) level \>80 in the 3 months prior to LT 14. Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB) 15. Receipt of any live-attenuated vaccine within 2 months of transplant. ADDITIONAL exclusion criteria to be reviewed at the time of transplant 1. Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \< 30 at the time of LT 2. Model for end-stage liver disease (MELD)-Na score \>30 3. Donor features of Donation after Cardiac Death (DCD), HCV Ab or nucleic acid testing (NAT+), HBcAb or HBsAg+, or blood types A, B, and O incompatible organ
Contact & Investigator
Elizabeth Verna, MD
PRINCIPAL INVESTIGATOR
Columbia University Irving Medical Center/ New York Presbyterian Hospital
Frequently Asked Questions
Who can join the NCT06455280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06455280 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06455280 currently recruiting?
Yes, NCT06455280 is actively recruiting participants. Contact the research team at tt2103@cumc.columbia.edu for enrollment information.
Where is the NCT06455280 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06455280 clinical trial?
NCT06455280 is sponsored by Elizabeth C. Verna. The principal investigator is Elizabeth Verna, MD at Columbia University Irving Medical Center/ New York Presbyterian Hospital. The trial plans to enroll 8 participants.