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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Cancer; GPC3 Positive Hepatocellular Carcinoma
• Intervention / Treatment: Biological: TC-G203 cells treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Changsong Qi; Phone Number: +8601050847838; Email: xiwangpku@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Beijing GoBroad Hospital
      • Contact: Qi Changsong Beijing Goabroad Hospital; Email: xiwangpku@126.com
    • Beijing, Beijing Municipality, China, 102206
      • Not yet recruiting
      • GoBroad Healthcare Group
      • Contact: Changsong Qi; Phone Number: +8601050847838; Email: xiwangpku@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TC-G203 Cell Therapy; TC-G203 CAR-T Cells Following lymphodepletion chemotherapy, participants will receive TC-G203 CAR-T cell infusion.	Biological: TC-G203 cells treatment; TC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.; Other Names: Cyclophosphamide; Fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response and Survival Outcomes	Objective Response Rate (ORR): Number of participants with complete response (CR) or partial response (PR) Duration of Response (DOR): Time from first documented response to disease progression or death Progression-Free Survival (PFS): Time from TC-G203 infusion to disease progression or death Overall Survival (OS): Time from TC-G203 infusion to death from any cause	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Persistence of TC-G203 in Peripheral Blood	Persistence of TC-G203 CAR-T cells in peripheral blood over time measured by qPCR and flow cytometry	Up to 24 months
Concentration of Pro-inflammatory Cytokines and Tumor Markers in Peripheral Blood	Serum levels of IL-6, TNF-α, IL-8, IFN-γ, CRP, AFP, and sGPC3 at specified time points	Up to 24 months

Collaborators and Investigators

• Sponsor: Beijing GoBroad Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Solid Cancer; GPC3 positive hepatocellular carcinoma
• Additional Relevant MeSH Terms: Simpson-Golabi-Behmel syndrome; Organic Chemicals; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclophosphamide; fludarabine
• Other Study ID Numbers: G203-IIT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No