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Clinical Trials in China / NCT07444281
Recruiting Phase 1

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

NCT07444281 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai AbelZeta Ltd.
Phase
Phase 1
Started
2024-12-25
Last updated
2026-03-03

Condition(s) studied

Squamous Cell Lung Cancer

Investigational drug(s) / intervention(s)

C-CAR031

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).

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * The left ventricular ejection fraction (LVEF) measured by echocardiography ≥50% and reported as non-impaired. * Sufficient pulmonary function * The laboratory testing results meet the study requirements * Female participants of childbearing potential must test negative for pregnancy in serum or urine. Non-sterilized participants (males and females) agree to take effective contraceptive measures for at least 12 months and until CAR-T below lower limit of detection (LLOD) by PCR which occurs last after C-CAR031 infusion. Exclusion Criteria: * 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 * Prior treatment with Any CAR-T therapy OR any therapy that is targeting GPC3 * Uncontrolled or intercurrent pulmonary disease * Clinically meaningful ascites * Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures * Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases * Received radiation therapy, local treatment, vaccine, blood transfusion, systemic treatment within certain period of apheresis required by study protocol * History of or with active diseases or conditions of that's defined in study protocol

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07444281 on ClinicalTrials.gov ↗ ← All trials in China