TC-G203 treatment for GPC3-positive advanced solid tumors

A Preliminary Clinical Study of TC-G203 for Patients With GPC3-Positive Recurrent/Metastatic Solid Tumors

This trial will test a single-dose TC-G203 cell therapy to see if it is safe and helps adults with GPC3-positive recurrent or metastatic solid tumors who have already tried other treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing GoBroad Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07242417 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, early-phase dose-escalation trial of a one-time TC-G203 cell infusion for patients with GPC3-positive recurrent or metastatic solid tumors. The protocol includes screening, leukapheresis to collect peripheral blood mononuclear cells, lymphodepletion chemotherapy, TC-G203 infusion, and close post-infusion follow-up. Doses will be escalated to determine the maximum tolerated dose while monitoring safety, tolerability, and in vivo expansion and persistence of the infused cells. Secondary measures include preliminary anti-tumor activity by RECIST and correlative biomarker analyses.

Who should consider this trial

Good fit: Adults 18–75 years with GPC3-positive recurrent or metastatic solid tumors, ECOG 0–1, measurable disease, adequate organ and marrow function, who have failed or are unsuitable for standard therapy and can undergo leukapheresis and lymphodepletion.

Not a fit: Patients with GPC3-negative tumors, uncontrolled CNS metastases, active infections, autoimmune disease, significant cardiac disease, immunodeficiency, recent other malignancies, pregnancy, or inability to undergo leukapheresis or lymphodepletion are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, TC-G203 could provide a new cell-therapy option that produces durable tumor responses for patients with GPC3-positive tumors who have exhausted standard treatments.

How similar studies have performed: Early-phase trials of GPC3-targeted cellular therapies and other CAR-T approaches in hepatocellular carcinoma have shown limited but promising anti-tumor signals, though durable benefit in solid tumors remains unproven.

Eligibility criteria

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. -

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Gobroad Hospital — Beijing, Beijing Municipality, China (Recruiting)
• GoBroad Healthcare Group — Beijing, Beijing Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Changsong Qi

Conditions Solid Cancer; GPC3 Positive Hepatocellular Carcinoma; GPC3 positive hepatocellular carcinoma