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

Early Phase 1RecruitingNCT07242417

Beijing GoBroad Hospital30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Cancer GPC3 Positive Hepatocellular Carcinoma

Interventions

TC-G203 cells treatmentBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. -

Locations (2)

Beijing Gobroad Hospital

Beijing, Beijing Municipality, China

RECRUITING

GoBroad Healthcare Group

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Within 28 days after TC-G203 infusion

Secondary Outcomes

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

Time frame: Up to 24 months

Central Contacts

Changsong Qi

CONTACT

+8601050847838 xiwangpku@126.com

Data from ClinicalTrials.gov

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