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| Name | Class |
|---|---|
| Beijing Geekgene Technology Co., LTD | INDUSTRY |
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This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GK01 injection | Experimental | Autologous tumor-reactive T cells injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK01 Injection | Drug | Autologous tumor-reactive T cells injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PK | Levels of T-cell Receptor copies | 2 years |
| Recurrence free survival(RFS) | RFS will will be assessed from radical surgery to death of any cause (evaluated according to the RECIST criteria). |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihui Hao | Contact | +86-02223340123 | haojihui@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Cancer Hospital Airport Hospital | Recruiting | Tianjin | China |
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| 2 years |
| Overall survival (OS ) | OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria) | 2 years |
| Patient Quality of Life | EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30) | 2 years |
| PD marker | Concentration levels of serum cytokines, tumor markers and other related markers. | 2 years |