C-CAR031 CAR T-cell infusion for GPC3-positive advanced 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
This trial will test a CAR T-cell infusion called C-CAR031 in adults with GPC3-positive advanced or metastatic squamous cell lung cancer who have progressed on or cannot tolerate up to three prior systemic treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai AbelZeta Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T, radiation, cyclophosphamide, fludarabine, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07444281 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label, multicenter Phase I trial that gives participants an infusion of C-CAR031 and follows them for safety, tolerability, anti-tumor activity, pharmacokinetics/pharmacodynamics, biomarker changes, and immunogenicity. Eligible adults have unresectable stage IIIB–IIIC or IV squamous cell lung cancer with tumors centrally confirmed to express GPC3, at least one measurable lesion, adequate cardiac and pulmonary function, and no more than three prior lines of systemic therapy. The primary focus is on characterizing safety and tolerability and identifying any preliminary signs of clinical benefit; secondary objectives include PK/PD, biomarker analyses, and immune response monitoring. Participants must agree to contraception requirements and receive care at participating investigational centers.
Who should consider this trial
Good fit: Adults with unresectable or metastatic squamous cell lung cancer whose tumors test positive for GPC3, who have at least one measurable lesion, adequate heart and lung function, and who have progressed on or cannot tolerate up to three prior systemic therapies are eligible.
Not a fit: Patients whose tumors do not express GPC3, who have received more than three prior systemic regimens, have significant organ dysfunction, or have actionable driver mutations with approved therapies are unlikely to benefit from this CAR-T approach.
Why it matters
Potential benefit: If successful, C-CAR031 could shrink tumors or control disease in GPC3-positive squamous cell lung cancer patients who have exhausted standard options.
How similar studies have performed: CAR T-cell therapies have had major success in blood cancers but limited, early-phase activity in solid tumors; GPC3-targeted CAR-T has shown preliminary signals in liver cancer but remains largely unproven in squamous cell lung cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shun Lu, MD — Shanghai Chest Hospital, China
- Study coordinator: Yinghua Shen
- Email: yinghua.shen@abelzeta.com
- Phone: +86-18616644879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.