Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CAR031 Cohort 1 | Experimental | Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects |
|
| C-CAR031 Cohort 2 | Experimental | Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects |
|
| C-CAR031 Cohort 3 | Experimental | Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-CAR031 | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| AE/SAE/AESI, DLT |
| From baseline to 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective Response Rate) | To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer | From baseline until disease progression likely at 12 months |
| CK Parameter and Quantification of CAR copies/μg DNA of C-CAR031 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yinghua Shen | Contact | +86-18616644879 | yinghua.shen@abelzeta.com |
| Name | Affiliation | Role |
|---|---|---|
| Shun Lu, MD | Shanghai Chest Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2024 | Feb 9, 2026 | Prot_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the CK of C-CAR031 |
| From baseline until 15 years of infusion as longest |
| Presence of RCL | To assess the safety of C-CAR031 | From baseline until 15 years of infusion as longest |
| DCR (Disease Control Rate) | To estimate the anti-tumor activity of C-CAR031 in participants with GPC3+ advanced/metastatic squamous cell lung cancer | From baseline until disease progression likely at 12 months after treatment |
| DoR (Duration of Response) | From baseline until disease progression likely at 12 months after treatment |
| DRR (Durable Response Rate) | From baseline until disease progression likely at 12 months after treatment |
| TTR (Time to Response) | From baseline until disease progression likely at 12 months after treatment |
| PFS (Progression-free Survival) | From baseline until disease progression likely at 12 months after treatment |
| Change in tumor size | From baseline until disease progression likely at 12 months after treatment |