C-CAR031: C-CAR031 is an autologous CAR T-cell product that expresses a CAR specific for GPC3 and a dominant-negative transforming growth factor-beta receptor II (dnTGFβRII).
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
AE/SAE/AESI, DLT — From baseline to 28 days after treatment * To assess the safety and tolerability of C-CAR031 in participants
* To determine the RDE (Phase Ia)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.