Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC

Launched by ORICELL THERAPEUTICS CO., LTD. · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for hepatocellular carcinoma (HCC), which is a type of liver cancer. The treatment being tested is called Ori-C101, a special type of immune cell therapy that uses modified T cells to target a protein called GPC3 found in some liver cancer tumors. This study aims to find out how safe this treatment is and whether it can help patients with advanced stages of HCC who have not responded to previous therapies.

To be eligible for this trial, participants need to have a confirmed diagnosis of HCC and show that their tumor expresses the GPC3 protein. They should have advanced cancer that cannot be surgically removed and have already tried at least two different treatments without success. Participants must also be in fairly good health, with a life expectancy of at least 12 weeks. Throughout the trial, patients will receive the treatment and be closely monitored for any side effects or benefits. This trial is currently recruiting participants of all genders aged 18 and older. If you're interested in learning more about joining the trial, your healthcare provider can provide additional information.

Gender

ALL

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.