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| Name | Class |
|---|---|
| Marino Biotechnology Co., Ltd. | INDUSTRY |
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This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or metastatic malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-mesothelin CAR T cells | Experimental | Dose escalation study aimed to assess the safety and efficacy of anti-mesothelin CAR T cells. CAR T dosage ranging from 5×10^4 /kg to 1×10^7 /kg will be tested . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-mesothelin CAR T cells | 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, patients are intravenously infused with anti-mesothelin CAR T cells in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%). |
| Measure | Description | Time Frame |
|---|---|---|
| safety of infusion of autologous anti-mesothelin CAR T cells as assessed by the incidents of treatment related adverse events per NCI CTCAE V4.0 | incidents of treatment related adverse events per NCI CTCAE V4.0 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| treatment response rate of anti-mesothelin CAR T cells | Defined as the overall response rate (ORR), the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on the response evaluation criteria in solid tumor version 1.1 (RECIST1.1). | 4 weeks |
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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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|
| progression free survival |
| 6 months |
| overall survival | 2 years |
| proliferation of anti-mesothelin CAR T cells in patients | measured by quantitative PCR and flow cytometry | 6 months |
| activation of anti-mesothelin CAR T cells in patients | measured by blood cytokine levels after CAR T cell infusion | 6 months |
| persistence of anti-mesothelin CAR T cells in patients | measured by quantitative PCR and flow cytometry | 1 year |