TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors

Beijing GoBroad Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: GPC3 Positive Hepatocellular Carcinoma; Solid Cancer

Treatments: Biological: TC-G203 cells treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07242417

G203-IIT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

TC-G203 Cell Therapy

Experimental group

Description:

TC-G203 CAR-T Cells Following lymphodepletion chemotherapy, participants will receive TC-G203 CAR-T cell infusion.

Treatment:

Biological: TC-G203 cells treatment