TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing GoBroad Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must voluntarily provide written informed consent.
Aged 18-75 years (inclusive).
Life expectancy ≥ 12 weeks.
ECOG performance status 0-1.
Disqualifiers
Primary CNS malignancy or uncontrolled CNS metastases.
Other malignancies within 5 years
Active autoimmune disease or history of autoimmune disease.
Immunodeficiency, including HIV positivity
Trial design
Design model
Single group
Treatments tested in this trial
TC-G203 cells treatment
Biological/VaccineTC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TC-G203 Cell TherapyExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Within 28 days after TC-G203 infusionSecondary outcomes
1
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 monthsOther outcomes
1
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
Time frame
Up to 24 months2
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
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov