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| Name | Class |
|---|---|
| Marino Biotechnology Co., Ltd. | INDUSTRY |
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A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or metastatic malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSR T cells | Experimental | A dose escalation clinical study aimed to assess the safety and efficacy of CSR T cells in patients with PD-L1 positive tumors. CSR T dosage ranging from: 5×10^4 /kg to 1×10^7 /kg will be tested. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous CSR T | Biological | Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, a prescribed dose of CSR T cells will be intravenously infused to patient in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0. | safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| treatment response rate of CSR T cell infusion | defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD). | 4 weeks |
| overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shidong Wei, MD | Contact | +86-13146634751 | liqinghe9644679@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinwen Sun, MD | China Meitan General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Meitan General Hospital | Recruiting | Beijing | 100028 | China |
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|
| 2 years |
| progression-free survival | 6 months |
| proliferation of CSR T cells in patients | 2 years |
| Persistence of CSR T cells in patients | 2 years |