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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
China Shanghai 10th People's Hospital
Shanghai, China
RECRUITINGIncidence 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.
Time frame: 28 days post administration of CAR-T-cells
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)
Time frame: 2 years post CAR T cell infusion
Objective response rate (ORR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
Objective response rate includes:CR、PR(Assessed based on RECIST1.1 criteria)
Time frame: 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
Time frame: 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)
Time frame: 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)
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Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Peak value of eripheral blood (Cmax)
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Area under the eripheral blood concentration versus time curve (AUC)
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Time of peak value
Time frame: 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
Time frame: 2 years post CAR T cell infusion