Clinical trial · Interventional
GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
NCT05352542CI-TRIAL-00079641terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): achieve the proof of concept
Summary
Brief summary (as posted)
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GPC3 Targeting CART Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GPC3 Targeting CART Cells
- description
- Each subject will receive GPC3 Targeting CART cells
- interventionNames
- Biological: GPC3 Targeting CART Cells
Primary outcomes (5)
- measure
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
- timeFrame
- Minimum 2 years after CART infusion (Day 1)
- description
- An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment
- measure
- Dose-limiting toxicity (DLT) rate
- timeFrame
- Minimum 2 years after CART infusion (Day 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent; 2. Age 18-75 years; 3. Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy; 4. GPC3 is detected positive by immunohistochemistry (IHC); 5. Child-Pugh score ≤ 7; 6. At least one assessable tumor lesion; 7. ECOG score: 0-1; 8. Expected survival ≥ 3 months; 9. Clinical laboratory values meet screening visit criteria Exclusion Criteria: 1. Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target; 2. Any previous GPC3 targeted therapy; 3. Prior antitumor therapy with insufficient washout period; 4. Brain metastases with central nervous system symptoms; 5. Pregnant or lactating women 6. HCV-Ab or/and HIV-Ab positive; active syphilis; 7. Severe underlying diseases 8. Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.