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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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
Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China
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.
Time frame: 1 year
Objective response rate to ALPP-CART infusion
The number of patients experience objective response from anti-ALPP CAR-T cells treatment
Time frame: Eight weeks
Progression-free survival to ALPP-CART infusion
To evaluate the progression-free survival (PFS) of anti-ALPP CAR-T cells in patients with mesothelin-positive advanced ovarian carcinoma.
Time frame: 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
Time frame: 6 months
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