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An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
Sponsor: Shanghai AbelZeta Ltd.
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.
Official title: An Investigator-initiated Phase I Trial of an Armored and GPC3-targeted Autologous CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-12-25
Completion Date
2028-01-30
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
C-CAR031
C-CAR031 is an autologous CAR T-cell product that expresses a CAR specific for GPC3 and a dominant-negative transforming growth factor-beta receptor II (dnTGFβRII).
Locations (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China