Clinical trial · Interventional
Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma (HCC)
Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma
NCT03084380CI-TRIAL-00026523unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-GPC3 CAR-T
- description
- Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion
- interventionNames
- Biological: Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
- timeFrame
- 4 weeks
- description
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Secondary outcomes (2)
- measure
- Efficacy: Overall complete remission rate defined by the standard response criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Expected to survive more than 3 months * PS 0-2 * Immunohistochemistry was confirmed to be GPC3 positive hepatocellular carcinoma * Patients with no ability to receive TACE combined with sorafenib * WBC\>3.5×1e+9/L,Hb\>90g/L,PLT\>75×1e+9/L * HBV DNA copy number less than 100/ml * ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L * Understand this test and have signed informed consent Exclusion Criteria: * Hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial * Decompensated liver cirrhosis, liver function Child-pugh C grade * Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous * Long-term use of immunosuppressive agents after organ transplantation * Screening indicated that the target cell transfection rate was less than 30% * Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization * Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization * Pregnant or lactating subjects * In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration * Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study
References
Publications (0)
Data not yet available
No reference posted for this study.