An Investigator-initiated Phase I Trial of an Armored and GPC3-targeted Autologous CAR T-cell Infusion C-CAR031 in Participants With GPC3 AdvancedMetastatic Squamous Cell Lung Cancer

What this Trial Is About

Researchers are evaluating C-CAR031, an autologous CAR T-cell therapy targeting GPC3, in adults with advanced or metastatic squamous cell lung cancer that cannot be cured and has progressed despite prior treatments. This Phase I, open-label, multicenter trial focuses on assessing the safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics, biomarkers, and immune response in patients who have had up to three prior lines of systemic therapy including immune checkpoint inhibitors and platinum-based chemotherapy. Participants will receive one of three dose levels of C-CAR031 infused into their bodies 0.75 million, 1.5 million, or 4.0 million CAR T-cells per kilogram. The study is non-randomized with no placebo group, and all participants receive the investigational treatment. The study includes monitoring for adverse events and dose-limiting toxicities within 28 days after treatment, with longer-term assessments continuing up to 15 years for some measures. Throughout the trial, participants will undergo regular evaluations including tumor assessments, laboratory tests, heart function checks, and monitoring of immune markers. Researchers will measure treatment safety, response rates, duration and control of disease, and changes in tumor size over about 12 months. Long-term follow-up for CAR T-cell presence and replication-competent lentivirus will continue for up to 15 years. The total participation time depends on individual treatment response and follow-up schedules.

An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer