Phase 2 Liver Cancer Trial, Recruiting NCT07053488 Sponsor: AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC Condition: Liver Cancer
Back to Liver Cancer

Phase 2 Liver Cancer Trial, Recruiting

NCT07053488
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between 16 and 85 years old who have severe liver disease or sudden liver failure and have been assessed as needing a liver transplant.
  • A donor liver from a deceased donor has been allocated and is available to be used in the study after the gene editing process.
  • No perfectly tissue-matched (HLA-matched) donor liver is immediately available — as the trial is designed for people receiving a liver that is not a perfect tissue match, most people waiting for a transplant are likely to meet this condition (confirm with trial site).
  • The person has been assessed as medically suitable for transplant surgery and able to tolerate the standard anti-rejection medicines used after a transplant.
  • The person is able to understand that this is an investigational (research) trial and is willing to sign a written consent form, including agreeing to receive a genetically modified organ and to be followed up long-term with regular blood tests and tissue samples.
  • The person is willing and able to attend all required study visits and follow-up appointments for the full duration of the trial.

Who may not be able to join:

  • People with a serious, uncontrolled infection — such as blood poisoning (sepsis) or active tuberculosis — that would increase the risks of transplant surgery or affect how results are measured.
  • People with HIV or other ongoing viral infections that are not well managed. People with hepatitis B or C may still be considered if their infection is well controlled, but active, replicating virus at the time of transplant would be a concern (confirm with trial site).
  • People who need more than just a liver transplant — for example, someone who needs both a liver and a kidney transplant at the same time — as the trial is only looking at liver transplants on their own.
  • People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test before the transplant and must agree to use reliable contraception, as the effects of a gene-edited organ and anti-rejection medicines on a pregnancy or infant are not known.
  • People with a serious illness unrelated to their liver disease that is expected to severely limit their life expectancy or make them unsuitable for surgery — for example, advanced heart failure or poorly controlled diabetes with complications.
  • People with a known severe allergic reaction to any of the substances used in the gene editing process (confirm with trial site for specific details).
  • People who are unable to follow the trial's strict monitoring schedule due to mental health, personal, or practical reasons — for example, having no reliable way to travel to appointments or no support network to help them attend.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +1 (302) 615-8388

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
18 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of Grade ≥3 Treatment-Emergent Adverse Events (TEAEs); Feasibility of Ex Vivo HLA Gene Editing; Graft Failure Rate at Day 90

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov