Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GPC3 Positive Hepatocellular Carcinoma | — | UNRESOLVED | — |
| Solid Cancer | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TC-G203 cells treatment | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TC-G203 Cell Therapy
- description
- TC-G203 CAR-T Cells Following lymphodepletion chemotherapy, participants will receive TC-G203 CAR-T cell infusion.
- interventionNames
- Biological: TC-G203 cells treatment
Primary outcomes (1)
- measure
- Incidence of Dose-Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD)
- timeFrame
- Within 28 days after TC-G203 infusion
- description
- DLT is defined as any CAR-T cell-related adverse event graded per ASTCT 2019 CRS criteria and NCI CTCAE v5.0, including: ≥Grade 4 hematologic toxicity not recovering to ≤Grade 2 by Day 28, ≥Grade 4 CRS lasting ≥3 days, ≥Grade 3 ICANS, or ≥Grade 3 non-hematologic toxicity lasting \>7 days (excluding fever, fatigue, nausea/vomiting).
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must voluntarily provide written informed consent. 2. Aged 18-75 years (inclusive). 3. Life expectancy ≥ 12 weeks. 4. ECOG performance status 0-1. 5. Failed or unsuitable for standard therapy. 6. At least one measurable lesion per RECIST 1.1. 7. GPC3-positive tumor confirmed by immunohistochemistry. 8. Adequate organ and bone marrow function. 9. Effective contraception required for participants of childbearing potential. 10. Adequate venous access for leukapheresis. Exclusion Criteria: 1. Primary CNS malignancy or uncontrolled CNS metastases. 2. Other malignancies within 5 years 3. Active autoimmune disease or history of autoimmune disease. 4. Immunodeficiency, including HIV positivity 5. Bleeding disorders (inherited or acquired). 6. Clinically significant cardiovascular disease. 7. Active infection (including tuberculosis, hepatitis C, syphilis). 8. Pregnant or breastfeeding women. 9. Severe systemic or psychiatric illness. 10. Prior cell or gene therapy. 11. Severe drug hypersensitivity history. 12. Investigator-assessed unsuitability for trial participation. -
References
Publications (0)
Data not yet available