TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TC-G203 cells treatment.
- Who it may be relevant to
- Registry conditions: Solid Cancer, GPC3 Positive Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Preliminary Clinical Study of TC-G203 for Patients With GPC3-Positive Recurrent/Metastatic Solid Tumors
Overview
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.
Detailed description
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of TC-G203 therapy in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) TC-G203 infusion, and (5) post-infusion follow-up.
Interventions
- Biological TC-G203 cells treatment
TC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Primary outcome measures
- Incidence of Dose-Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) [Time frame: Within 28 days after TC-G203 infusion]
Secondary outcome measures (1)
- Tumor Response and Survival Outcomes [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Gobroad Hospital — Beijing
- GoBroad Healthcare Group — Beijing
Identifiers
NCT: NCT07242417 · G203-IIT-01