Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC
NCT ID: NCT05652920
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2022-12-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ori-C101 ( GPC3-directed chimeric antigen receptor modified T cells )
Ori-C101
Hepatic arterial infusion
Interventions
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Ori-C101
Hepatic arterial infusion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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OriCell Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Hunan Cancer Hospital
Changsha, Hunan, China
The first hospital of Jilin University
Changchun, Jilin, China
West China Hospital
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
Zhongshan Hospital Fudan University
Shanghai, , China
Countries
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Facility Contacts
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Jian Zhou, MD
Role: backup
Other Identifiers
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Ori-C101-P1
Identifier Type: -
Identifier Source: org_study_id
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