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| Name | Class |
|---|---|
| TCRCure Biopharma Ltd. | INDUSTRY |
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The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive Advanced Solid Tumors.
Primary Objectives:
To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells.
Secondary Objectives:
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with ALPP-positive patients.
The number and percent of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CART treatment | Experimental | Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retroviral vector-transduced autologous T cells to express anti-ALPP CARs | Drug | Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients suffering treatment-related AE | To evaluate the number of ALPP-positive participants with treatment-related adverse events as assessed by CTCAE v4.0 after infusion with anti-ALPP CAR-T cells. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate to ALPP-CART infusion | The number of patients experience objective response from anti-ALPP CAR-T cells treatment | Eight weeks |
| Progression-free survival to ALPP-CART infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Xinqiao Hospital | Chongqing | Chongqing Municipality | 400037 | China |
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To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma.
| 6 months |
| Number of peripheral CAR-T after infusion | The number of ALPP-CART cells in peripheral blood from ALPP-positive patients at 6 months after infusion | 6 months |