NCT07444281 An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
| NCT ID | NCT07444281 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai AbelZeta Ltd. |
| Condition | Squamous Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-12-25 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-12-25 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Shun Lu, MD
PRINCIPAL INVESTIGATOR
Shanghai Chest Hospital, China
Frequently Asked Questions
Who can join the NCT07444281 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Squamous Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07444281 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07444281 currently recruiting?
Yes, NCT07444281 is actively recruiting participants. Contact the research team at yinghua.shen@abelzeta.com for enrollment information.
Where is the NCT07444281 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07444281 clinical trial?
NCT07444281 is sponsored by Shanghai AbelZeta Ltd.. The principal investigator is Shun Lu, MD at Shanghai Chest Hospital, China. The trial plans to enroll 24 participants.
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