C-CAR031 CAR T-cell infusion for GPC3-positive advanced squamous cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.