CAR T-cell therapy for advanced liver cancer

A Phase Ib/II, Open-Label, Multi-Center Study to Investigate the Safety, PK, and Efficacy of Ori-C101 in Advanced Hepatocellular Carcinoma (HCC) Patients (BEACON)

This study is testing a new type of immune therapy called Ori-C101 to see if it can help people with advanced liver cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: OriCell Therapeutics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, chemotherapy, immunotherapy, chimeric antigen receptor
• Locations: 7 sites (Beijing, Beijing Municipality and 6 other locations)
• Trial ID: NCT05652920 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with confirmed advanced hepatocellular carcinoma expressing GPC3 who have received at least two prior systemic therapies.

Not a fit: Patients with resectable HCC or those who have not progressed after initial therapies may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who have limited treatment alternatives.

How similar studies have performed: While CAR T-cell therapies have shown promise in other cancers, this specific approach targeting GPC3 in HCC is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 6 other locations

• 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)
• Zhongshan Hospital Fudan University — Shanghai, China (Recruiting)

Conditions Hepatocellular Carcinoma