CAR T-cell therapy for advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I/II clinical trial evaluates the safety and preliminary efficacy of Ori-C101, a chimeric antigen receptor modified T cell therapy targeting GPC3, in patients with advanced hepatocellular carcinoma (HCC). The study is open-label and multi-center, focusing on patients with unresectable HCC who have previously undergone systemic therapies. Participants will receive injections of Ori-C101 to assess how well the treatment works and its pharmacokinetics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Confirmed pathologic or radiologic diagnosis of HCC ;
2. Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for GPC3 expression test;
3. Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;
4. Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;
5. Child-Pugh A or B7, no history of hepatic encephalopathy;
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
7. Estimated life expectancy of minimum of 12 weeks;
8. Must have at least 1 target lesion

Exclusion Criteria:

1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
2. Prior bone marrow or organ transplantation;
3. Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ;
4. Active hepatitis B infection (If Hepatitis B surface antigen \[HBsAg\] or Hepatitis B core antibody \[HBcAb\] positive, then HBV-DNA must be \< 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral therapies as per the local guidelines);
5. Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
6. Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
7. Inadequate bone marrow reserve or organ function;
8. History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator, is not in the best interest of the patient to participate.
9. Pregnant or Breast-feeding women.

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• The first hospital of Jilin University
  Changchun, Jilin, China Recruiting
• West China Hospital
  Chengdu, Sichuan, China Recruiting
• Sir Run Run Shaw Hospital
  Hangzhou, Zhejiang, China Recruiting
• Lishui Central Hospital
  Lishui, Zhejiang, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GPC3-targeted CAR T cells armored with IL-15 and IL-21 for pediatric non‑CNS solid tumors

  This treatment will try personalized CAR T cells that target GPC3 and are engineered to make IL‑15 and IL‑21 in children and young adults with relapsed or refractory non‑CNS solid tumors that express GPC3.

  Recruiting Phase 1 Seattle Children's Hospital · Seattle, Washington · NCT07148050

• IL-15 and IL-21–armored GPC3-CAR T cell therapy for adults with GPC3-positive solid tumors

  This trial tests whether CAR T cells engineered to target GPC3 and fortified with IL-15 and IL-21 can treat adults with GPC3-positive liver and other solid tumors.

  Recruiting Phase 1 Baylor College of Medicine · Houston, Texas · NCT06198296

• CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults

  This observational study looks at adults who receive CAR-T cell therapy or bispecific antibodies to see which factors predict response and immune-related side effects.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07915102

• Natalizumab to help prevent brain-related side effects during CAR-T therapy in certain lymphoma patients

  This phase 2 study tests whether natalizumab can reduce severe ICANS in adults with recurrent or refractory DLBCL or MCL receiving CAR-T therapy.

  Recruiting Phase 2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07892027

• CD19 CAR-T Therapy for Kids with Refractory Childhood SLE

  This study tests whether a patient’s own CD19 CAR-T cells can help children and young adults with severe, hard-to-treat lupus.

  Recruiting Phase 1 Seoul National University Hospital · Seoul · NCT07855302

• InstaSure Non-Invasive Finger-Press Test for HCC

  This study tests a non-invasive finger-skin test to help identify hepatocellular carcinoma in adults.

  Recruiting Beijing Municipal Administration of Hospitals · Beijing, Beijing Municipality · NCT07848750

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.