Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Lung Cancer | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-CAR031 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- C-CAR031 Cohort 1
- description
- Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects
- interventionNames
- Drug: C-CAR031
- type
- EXPERIMENTAL
- label
- C-CAR031 Cohort 2
- description
- Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects
- interventionNames
- Drug: C-CAR031
- type
- EXPERIMENTAL
- label
- C-CAR031 Cohort 3
- description
- Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available