TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors
A Preliminary Clinical Study of TC-G203 for Patients With GPC3-Positive Recurrent/Metastatic Solid Tumors
Beijing GoBroad Hospital
30 participants
Dec 18, 2025
INTERVENTIONAL
Conditions
Summary
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-G203 in patients with GPC3-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Eligibility
Inclusion Criteria10
- Participants must voluntarily provide written informed consent.
- Aged 18-75 years (inclusive).
- Life expectancy ≥ 12 weeks.
- ECOG performance status 0-1.
- Failed or unsuitable for standard therapy.
- At least one measurable lesion per RECIST 1.1.
- GPC3-positive tumor confirmed by immunohistochemistry.
- Adequate organ and bone marrow function.
- Effective contraception required for participants of childbearing potential.
- Adequate venous access for leukapheresis.
Exclusion Criteria12
- Primary CNS malignancy or uncontrolled CNS metastases.
- Other malignancies within 5 years
- Active autoimmune disease or history of autoimmune disease.
- Immunodeficiency, including HIV positivity
- Bleeding disorders (inherited or acquired).
- Clinically significant cardiovascular disease.
- Active infection (including tuberculosis, hepatitis C, syphilis).
- Pregnant or breastfeeding women.
- Severe systemic or psychiatric illness.
- Prior cell or gene therapy.
- Severe drug hypersensitivity history.
- Investigator-assessed unsuitability for trial participation. -
Interventions
TC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07242417