An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-CAR031.
- Who it may be relevant to
- Registry conditions: Squamous Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug 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).
Primary outcome measures
- AE/SAE/AESI, DLT [Time frame: From baseline to 28 days after treatment]
Secondary outcome measures (9)
- ORR (Objective Response Rate) [Time frame: From baseline until disease progression likely at 12 months]
- CK Parameter and Quantification of CAR copies/μg DNA of C-CAR031 [Time frame: From baseline until 15 years of infusion as longest]
- Presence of RCL [Time frame: From baseline until 15 years of infusion as longest]
- DCR (Disease Control Rate) [Time frame: From baseline until disease progression likely at 12 months after treatment]
- DoR (Duration of Response) [Time frame: From baseline until disease progression likely at 12 months after treatment]
- DRR (Durable Response Rate) [Time frame: From baseline until disease progression likely at 12 months after treatment]
- TTR (Time to Response) [Time frame: From baseline until disease progression likely at 12 months after treatment]
- PFS (Progression-free Survival) [Time frame: From baseline until disease progression likely at 12 months after treatment]
- Change in tumor size [Time frame: From baseline until disease progression likely at 12 months after treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07444281 · 0926-045