Status:
SUSPENDED
GPC3-CAR-T Cells for the Hepatocellular Carcinoma
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Collaborating Sponsors:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma.
Detailed Description
GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3. Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously inf...
Eligibility Criteria
Inclusion
- Age ≧18years, gender unlimited.
- Failure or intolerance after at least first-line treatment.
- GPC3 positive(IHC)
- Patients must have at least one target lesion available for evaluation.
- BCLC B or C.
- Child-Pugh grade A or B
- ECOG is 0 or 1 (one week before enrollment.)
- Estimated life expectancy ≥ 3 months.
- Functioning of major organs are normal.
- Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
- Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
Exclusion
- There are uncontrollable active infections that need systemic treatment.
- HIV antibody is positive or syphilis antibody is positive.
- Pregnant or lactating women.
- hepatic encephalopathy.
- patients with organ failure:
- Heart: NYHA heart function grade IV;
- Liver: Grade C that achieves Child-Turcotte liver function grading;
- Kidney: kidney failure and uremia;
- Lung: symptoms of respiratory failure;
- Brain: a person with a disability.
- It is undergoing systemic hormones therapy.
- Impact results show that over 50% of the liver is occupied by tumor .
- Patients who are still in the observation stage of other antitumor drugs 30 days before blood collection.
- Patients were received other gene therapy products, or are participating in other clinical trials within 4 weeks prior to cell infusion.
- Abnormal thyroid function ≧Level 3.
- Active autoimmune diseases require systemic treatment during the first two years of screening.
- Patients have mental illness or history of drug abuse.
- Patients are participating in other clinical studies.
- The researchers found that it was unsuitable for the recipients to be enrolled.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04506983
Start Date
June 10 2022
End Date
October 10 2023
Last Update
February 14 2022
Active Locations (1)
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1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China