Clinical trial NCT05652920: Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: OriCell Therapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Maximum tolerated dose of Ori-C101
timeFrame: 1 year
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
References: