Clinical Trials in China / NCT07242417
Recruiting
Early Phase 1
TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors
NCT07242417 · tracked via the Priya Life Science China tracker
Condition(s) studied
Solid CancerGPC3 Positive Hepatocellular Carcinoma
Investigational drug(s) / intervention(s)
TC-G203 cells treatment: TC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Study 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 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. -
Primary outcome measure(s)
- Incidence of Dose-Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) — Within 28 days after TC-G203 infusion
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).
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Gobroad Hospital | Beijing | Beijing Municipality | Recruiting |
| GoBroad Healthcare Group | Beijing | Beijing Municipality | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07242417 on ClinicalTrials.gov ↗ ← All trials in China