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| Name | Class |
|---|---|
| Shanghai 10th People's Hospital | OTHER |
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This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .
Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U87 CAR-T cells | Experimental | The Patients are enrolled into 2 dose level cohorts in sequence |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U87 CAR-T | Drug | Subjects will be pretreated with cyclophosphamide 250~500 mg/m2( body surface area) for 3 days prior to Intravenous injection of U87, followed by intraartery of U87 14 days later with intravenous IL-2. Researchers can perform intratumoral injection based on their judgment.This study will explore two dose of dose 1 (DL-1): 1×106 (±20%) to dose 2 (DL-2): 1×107 (±20%),each group was enrolled in 3~6 patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability] | Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Dose-limiting toxicity after U87 CAR-T cells infusion. | 28 days post administration of CAR-T-cells |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness] | Disease control rate: including CR, PR and SD(Assessed based on RECIST 1.1 criteria) | 2 years post CAR T cell infusion |
| Objective response rate (ORR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maoquan Li, doctor | Contact | 021-66300114*3506 | cjr.limaoquan@vip.163.com | |
| Shilong Han, doctor | Contact | 021-66303247 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Shanghai 10th People's Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Objective response rate includes:CR、PR(Assessed based on RECIST1.1 criteria) |
| 2 years post CAR T cell infusion |
| Duration of Response (DOR) of U87 CAR-T cells treatment in advanced solid tumot[Effectiveness] | DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause | 2 years post CAR T cell infusion |
| Progress-free survival(PFS) of U87 CAR-T cells treatment in advanced solid tumor[Effectiveness] | PFS will be assessed from the first U87 CAR-T cells infusion to death from any cause or the first assessment of progression(Assessed based on RECIST1.1 ) criteria) | 2 years post CAR T cell infusion |
| Overall survival(OS) of U87 CAR-T cells treatment in advanced solid tumor [Effectiveness] | OS will be assessed from the first U87 CAR-T cells infusion to death from any cause (Assessed based on RECIST 1.1 criteria) | 2 years post CAR T cell infusion |
| Pharmacokinetics of U87 CAR-T cells | Peak value of eripheral blood (Cmax) | 2 years post CAR T cell infusion |
| Pharmacokinetics of U87 CAR-T cells | Area under the eripheral blood concentration versus time curve (AUC) | 2 years post CAR T cell infusion |
| Pharmacokinetics of U87 CAR-T cells | Time of peak value | 2 years post CAR T cell infusion |
| Pharmacodynamics of U87 CAR-T cells | Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, IL-2, TNFα, ferritin and CRP at each time point | 2 years post CAR T cell infusion |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |