NCT07444281RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- Dec 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07444281
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From Dec 2024 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- known to harbor a driver mutation for which targeted standard therapy is recommended in accordance with local treatment guidelines.
- Prior treatment with Any CAR-T therapy OR any therapy that is targeting GPC3
- Received radiation therapy, local treatment, vaccine, blood transfusion, systemic treatment within certain period of apheresis required by study protocol
Other illness
- Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO)
- History of splenectomy or organ transplantation
- Uncontrolled or intercurrent pulmonary disease
- Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases
- History of or with active diseases or conditions of that's defined in study protocol
Other
- Contraindication to lymphodepleting agents, including fludarabine and/or cyclophosphamide.
- Clinically meaningful ascites
- Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.