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.
Histologically or cytologically confirmed unresectable Stage IIIB ,IIIC or IV squamous cell lung cancer
Confirmed to express GPC3, as assessed by immunohistochemistry at a central lab
Participants who have progressed or intolerant to no more than three lines of prior systemic therapies for advanced/metastatic squamous cell lung cancer
At least one measurable target lesion
known to harbor a driver mutation for which targeted standard therapy is recommended in accordance with local treatment guidelines.
Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO)
Contraindication to lymphodepleting agents, including fludarabine and/or cyclophosphamide.
History of splenectomy or organ transplantation