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This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCG101 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCG101 | Biological | Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). | Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria | Start of SCG101 infusion until disease progression or 12 months post infusion |
| The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). | Per mRECIST and iRECIST | Start of SCG101 infusion until disease progression or 12 months post infusion |
| Change in pharmacodynamics markers (PD) before and after SCG101 infusion | Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP | Start of SCG101 infusion until disease progression, an average of 24 months |
| Persistences of viral vector copy number (VCN) after SCG101 infusion | Start of SCG101 infusion until disease progression, an average of 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SCG Cell Therapy | Contact | 021-50339500 | clinicaltrials@scgcell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | Recruiting | Beijing | Beijing Municipality | 100020 | China | |
| Guangzhou |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Recruiting |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Zhengzhou | Recruiting | Zhengzhou | Henan | 450003 | China |
| Changchun | Recruiting | Changchun | Jilin | 130000 | China |
| Shenyang | Recruiting | Shenyang | Liaoning | 110000 | China |
| Ji'nan | Recruiting | Ji'nan | Shandong | 250000 | China |
| Shanghai | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |