A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, and Initial Efficacy of a GPC3-targeted Chimeric Antigen Receptor Autologous T Cell Injection (OriC902) in GPC3-positive Advanced Hepatocellular Carcinoma (HCC) Subjects

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a Phase I clinical study evaluating the safety, pharmacokinetics, and initial efficacy of a GPC3-targeted chimeric antigen receptor autologous T cell injection (OriC902) in GPC3-positive advanced hepatocellular carcinoma (HCC) subjects

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Understand and voluntarily sign an informed consent form (ICF) prior to conducting any assessment/procedure related to the study;

• Ages 18 to 75 at the time of signing the ICF (including 18 and 75);

• HCC was diagnosed according to the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 edition);

• Samples of liver tumor tissue or extrahepatic metastases within 1 year of signing the pre-screening informed consent were 1+ or more positive by immunohistochemical detection of GPC3 in tumor cells of at least 5% (dose escalation phase) or 10% (dose expansion phase);

• BCLC stage B HCC or BCLC stage C HCC that are not suitable for local therapy or relapse after local therapy and cannot be cured;

• Failure of standard treatment (including but not limited to targeted therapy, immunotherapy, or chemotherapy), which is determined by imaging as disease progression;

• Child-Pugh A or B7 without hepatic encephalopathy;

• An ECOG score of 0 or 1;

• The expected survival is not less than 12 weeks;

⁃ According to RECIST 1.1, subjects have at least one measurable lesion (lesions that have received local treatment such as radiotherapy need to be identified by imaging for definite progression), and the longest diameter at baseline for CT or MRI imaging evaluation must be ≥10 mm (except lymph nodes, whose short diameter must be ≥15 mm);

⁃ Can carry out normal venous blood collection and machine simple collection, can establish the necessary venous access for collection, no contraindications for white blood cell collection;

⁃ The researchers judged that lymphocyte clearance therapy could be performed;

⁃ Fertile men and women of childbearing age must consent to the use of effective contraception from the signing of the master informed consent until 2 years after the study drug use. Women of reproductive age include women before menopause and women within 2 years after menopause. Blood pregnancy tests for women of childbearing age must be negative at the time of screening.

Locations
Other Locations
China
Beijing GoBroad Hospital
RECRUITING
Beijing
Peking University Cancer Hospital & Institute
NOT_YET_RECRUITING
Beijing
Contact Information
Primary
Changsong Qi
xiwangpku@126.com
13811394004
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 44
Treatments
Experimental: OriC902
OriC902 injection, dosage is divided into 1E6/Kg, 3E6/ Kg, 6E6/Kg, 1E7/Kg
Related Therapeutic Areas
Sponsors
Collaborators: OriCell Therapeutics Co., Ltd.
Leads: Peking University

This content was sourced from clinicaltrials.gov

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