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Clinical Trials in China / NCT05652920
Recruiting Phase 1/2

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

NCT05652920 · tracked via the Priya Life Science China tracker
Sponsor
OriCell Therapeutics Co., Ltd.
Phase
Phase 1/2
Started
2022-12-15
Last updated
2024-04-03

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Ori-C101

Ori-C101: Hepatic arterial infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (7)

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

More OriCell Therapeutics Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05652920 on ClinicalTrials.gov ↗ ← All trials in China