An Early Phase 1 interventional study of TC-G203 cells treatment in Solid Cancer and GPC3 Positive Hepatocellular Carcinoma, sponsored by Beijing GoBroad Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Beijing GoBroad Hospital · Early Phase 1, Interventional, and Treatment
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.
Beijing GoBroad Hospital is the lead sponsor of 35 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Cyclophosphamide, Fludarabine
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
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
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 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
Time frame: Up to 24 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing GoBroad Hospital