CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection

This early-phase clinical trial will assess the use of ex vivo CRISPR-Cas9 genome editing on donor liver grafts to reduce immunogenicity before transplantation. Donor livers will have HLA-A and HLA-B genes knocked out, and HLA class II expression disabled (by targeting the CIITA transactivator gene), aiming to create a "hypoimmunogenic" organ less prone to rejection. The edited liver is then transplanted into patients with end-stage liver disease. The primary focus is on safety and feasibility - determining whether a CRISPR-edited liver can be transplanted successfully and function normally -

Trial Details

NCT ID

NCT07053488

Phase

PHASE1 / PHASE2

Sponsor

AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC

Status

RECRUITING

Cancer Type

Liver Cancer

Interventions

Ex Vivo CRISPR-Cas9 Gene Editing of Donor Liver

Locations (sample)

Beijing, Changping, China|39.9075,116.39723

Key Eligibility Criteria

Adults aged 16-85 (inclusive) with end-stage liver disease or acute liver failure who are eligible for liver transplantation.
Require a liver transplant and have been allocated a donor liver graft (from a deceased donor) that will be used in the study after gene editing.
No immediately available fully HLA-matched donor (since the study targets patients who would otherwise receive an HLA-mismatched organ; standard al…
Medically suitable for transplant surgery and able to tolerate standard immunosuppressive therapy (no contraindications to transplant such as uncon…

For full eligibility, visit ClinicalTrials.gov.

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