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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 immune checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or refractory malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 antibody expressing CAR-T cells | Experimental | PD-1 antibody expressing mesothelin specific CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody expressing mesothelin specific CAR-T cells | Biological | Patients will receive an IV infusion of PD-1 antibody expressing mesothelin specific CAR engineered peripheral blood leukocyte. On day 21, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of infusion of autologous mesothelin specific CAR T cells | Safety of infusion of autologous mesothelin specific CAR T cells with PD-1 antibody expressing in patients with relapsed or refractory advanced solid malignancies using the NCI CTCAE V4.0 criteria | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| the response evaluation criteria of solid tumor | 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). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change of life quality after treatment | 2 years | |
| proliferation and persistence of mesothelin specific CAR T cells in patients after treatment | 6 months | |
| expression of PD-1 antibody in patients after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huajun Jin, PhD | Contact | 86-13162257545 | hj_jin@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qijun Qian, PhD | Shanghai Cell Therapy Engineering Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo No.5 Hospital (Ningbo Cancer Hospital) | Recruiting | Ningbo | Zhejiang | China |
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|
| progression free survival |
| 1 year |
| overall survival | 2 years |
| 6 months |