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| Name | Class |
|---|---|
| Cells & Genes Biotech | UNKNOWN |
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This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate but uneffective systemic standard treatments.
This study is a single-centre, open-label, dose-escalation exploratory clinical trial. Its objective is to evaluate the safety, tolerability, recommended dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C infused in participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate systemic standard treatments. The study will be carried out in accordance with the protocol. Due to the early-stage of the exploratory clinical research,, the anticipated sample size for the three dose groups is 7-12 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG-102-12C | Biological | Chimeric Antigen Receptor Autologous T-cell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | Describe the adverse events of limiting further increases in the dose of CG-102-12C | Within 28 days of CG-102-12C infusion |
| Treatment-emergent adverse events (TEAEs) | Describe adverse events (AEs) and serious adverse events (SAEs) that are related to the study treatment during the treatment period. | Within 24 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate by RECIST 1.1. | From treatment of the first subject to completion of follow-up of the last subject (up to 5 years) |
| Disease control rate (DCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Immune cell subsets endpoint | The proportion of peripheral blood immune cells at different sampling points before and after the reinfusion of CG-102-12C injection. | Within 28 days of CG-102-12C infusion |
| Cytokine / inflammation related protein endpoint |
Inclusion Criteria:
Exclusion Criteria:
Note: This time requirement (i.e., within 5 years) does not apply to patients with adequately treated carcinoma in situ of the cervix, localized squamous cell carcinoma of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma \
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Zhang, Professor | Contact | 0571-87233418 | 086-1381913711 | qi.zhang@zju.edu.cn |
| Fan Yang | Contact | +86 18811588022 | 18811588022@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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The proportion of patients whose disease is controlled, which includes those who achieve a complete response (CR), partial response (PR), or stable disease (SD), out of the total number of evaluable patients.
| within 1 year after the last subject was treated |
| Duration of remission (DOR) | Duration of response by RECIST 1.1 | From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years) |
| Time to remission (TTR) | Time to remission by RECIST 1.1 | From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years) |
| Progression free survival (PFS) | Progression-free survival by RECIST 1.1 | From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years) |
| Overall survival (OS) | Overall survival by RECIST 1.1. | From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years) |
| CAR-T Cmax | Describe the peak concentration of CG-102-12C in vivo | Within 28 days of CG-102-12C infusion |
| CAR-T Tmax | Describe the time from infusion to reaching peak concentration of CG-102-12C in vivo | Within 28 days of CG-102-12C infusion |
IL-2, IL-2 and IL-2 before and after reinfusion of CG-102-12C injection The concentration levels of IL-6, IL-15, IL-21, IFN-γ, TNF α, C-reactive protein, ferritin.
| Within 28 days of CG-102-12C infusion |
| First Affiliated Hospital, Medical College of Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
|