TC-G203 treatment for GPC3-positive advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Gobroad Hospital
  Beijing, Beijing Municipality, China Recruiting
• GoBroad Healthcare Group
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Changsong Qi
• Email: xiwangpku@126.com
• Phone: +8601050847838

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.