RecruitingPhase 1NCT07444281

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

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


Sponsor

Shanghai AbelZeta Ltd.

Enrollment

24 participants

Start Date

Dec 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase I study is testing a new CAR-T cell therapy called C-CAR031 — an experimental treatment where a patient's own immune cells are genetically modified to recognize and attack cancer cells — for people with advanced squamous cell lung cancer that expresses a protein called GPC3. This is an early safety and dosing study. **You may be eligible if...** - You have confirmed advanced or metastatic squamous cell lung cancer (stage IIIB, IIIC, or IV) that cannot be surgically removed - Your tumor tests positive for the GPC3 protein - You have received up to three prior lines of treatment for your lung cancer and either progressed or could not tolerate them - Your heart's pumping function is normal (ejection fraction 50% or above) - Your lung function and blood counts are adequate **You may NOT be eligible if...** - Your cancer has a targetable driver mutation for which a standard targeted drug is recommended (e.g., EGFR, ALK) - You have had a prior CAR-T cell therapy or any GPC3-targeting treatment - You have had a splenectomy or organ transplant - You have active, uncontrolled lung disease, significant fluid around the lungs or heart, or cancer spreading to the brain or spinal cord - You have known severe allergies to the CAR-T product or its components Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGC-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

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NCT07444281


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