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

NCT07242417 | Recruiting Early Phase 1

• 1 other identifier: G203-IIT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Cancer; GPC3 Positive Hepatocellular Carcinoma

Keywords

Solid Cancer; GPC3 positive hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD)

  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).

  Within 28 days after TC-G203 infusion

Secondary Outcomes (1)

• Tumor Response and Survival Outcomes

  Up to 24 months

Other Outcomes (2)

• Duration of Persistence of TC-G203 in Peripheral Blood

  Up to 24 months

• Concentration of Pro-inflammatory Cytokines and Tumor Markers in Peripheral Blood

  Up to 24 months

Study Arms (1)

TC-G203 Cell Therapy

EXPERIMENTAL

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

Biological: TC-G203 cells treatment

Interventions

TC-G203 cells treatment BIOLOGICAL

TC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.

Also known as: Cyclophosphamide, Fludarabine

TC-G203 Cell Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (2)

Beijing Gobroad Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

GoBroad Healthcare Group

Beijing, Beijing Municipality, 102206, China

NOT YET RECRUITING

MeSH Terms

Interventions

Cyclophosphamide; fludarabine

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Changsong Qi

CONTACT

+8601050847838; xiwangpku@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)