This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with CEA-positive advanced malignant solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12-24 subjects with CEA-positive advanced malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Administration method: intravenous infusion or intraperitoneal injection; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China
Incidence of Adverse events after CEA-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)
Time frame: 28 days
Obtain the maximum tolerated dose of CEA-CAR-T cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Time frame: 28 days
Disease control rate of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Disease control rate: including CR, PR and SD
Time frame: 3 months
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Changes in serum tumor markers:CEA、 CA199、 CA125
Time frame: 3 months
AUCS of CEA-CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 28 days and 90 days
Time frame: 1 years
CMAX of CEA-CAR-T cells [Cell dynamics]
CMAX is defined as the highest concentration of CEA-CAR-T cells expanded in peripheral blood
Time frame: 1 years
TMAX of CEA-CAR-T cells[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Time frame: 1 years
Pharmacodynamics of CEA-CAR-T cells[Cell dynamics]
The content of free CEA in peripheral blood at each time point measured by Chemiluminescence immunoassay
Time frame: 1 years
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