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)

OriCell Therapeutics Co., Ltd.7 sites in 1 country105 target enrollmentDecember 15, 2022

ConditionsHepatocellular Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: OriCell Therapeutics Co., Ltd.
Enrollment: 105
Locations: 7
Primary Endpoint: Maximum tolerated dose of Ori-C101
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).

Registry

clinicaltrials.gov

Start Date

December 15, 2022

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

OriCell Therapeutics Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Confirmed pathologic or radiologic diagnosis of HCC ;
•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;
•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;
•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;
•Child-Pugh A or B7, no history of hepatic encephalopathy;
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
•Estimated life expectancy of minimum of 12 weeks;
•Must have at least 1 target lesion

Exclusion Criteria

•Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
•Prior bone marrow or organ transplantation;
•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;
•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);
•Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
•Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
•Inadequate bone marrow reserve or organ function;
•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.
•Pregnant or Breast-feeding women.