Actively Recruiting
An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
Led by Shanghai AbelZeta Ltd. · Updated on 2026-03-03
24
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable Stage IIIB, IIIC, or IV squamous cell lung cancer
- Confirmed GPC3 expression by immunohistochemistry at a central lab
- Progressed or intolerant to no more than three prior systemic therapies for advanced/metastatic squamous cell lung cancer
- At least one measurable target lesion
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography
- Sufficient pulmonary function
- Laboratory test results meeting study requirements
- Female participants of childbearing potential must test negative for pregnancy
- Non-sterilized participants agree to use effective contraception for at least 12 months and until CAR-T is undetectable by PCR after infusion
You will not qualify if you...
- Known driver mutation for which targeted standard therapy is recommended
- Life-threatening allergies, hypersensitivity, or intolerance to CAR-T product or its components including DMSO
- Contraindications to lymphodepleting agents such as fludarabine or cyclophosphamide
- History of splenectomy or organ transplantation
- Prior treatment with any CAR-T therapy or GPC3-targeted therapy
- Uncontrolled or intercurrent pulmonary disease
- Clinically meaningful ascites
- Uncontrolled pleural or pericardial effusion requiring frequent drainage
- Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases
- Recent radiation, local treatment, vaccine, blood transfusion, or systemic treatment within protocol-specified periods
- History of or active diseases or conditions as defined by study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yinghua Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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