drugset / Trial / NCT07444281
An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This single-arm, open-label, multicenter, Phase I study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK)/pharmacodynamics (PD), biomarker, and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/metastatic squamous cell lung cancer, who are not amenable to curative therapy and have progressed or are intolerant to no more than 3 lines of prior systemic treatment including immune checkpoint inhibitors (CPIs) and platinum-based doublet chemotherapy, concurrently or sequentially.
Timeline
- Start
- 2024-12-25
- Primary completion
- 2027-04-30
- Completion
- 2028-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | C-CAR031 | Cell therapy | 750000 cells/kg | Other |
| Subject | C-CAR031 | Cell therapy | 1.5e+06 cells/kg | Other |
| Subject | C-CAR031 | Cell therapy | 4e+06 cells/kg | Other |