This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC), glypican-3 (GPC3) and carcinoembryonic antigen (CEA).
Aged 18-70, regardless of gender;
Diagnosed as EphA2or Claudin18.2, TROP2, HER2, GCC, GPC-3, CEA positive advanced solid tumors, such as lung cancer, liver cancer, colorectal cancer, gastric cancer, etc; Note: Advanced solid tumors refer to locally advanced (stage III patients) and metastatic advanced (stage IV patients) TNM staging by the American Cancer Society (AJCC).
Immunohistochemical analysis of pathological tissue approves positive expression for one of the following antigens, including EphA2, Claudin18.2, TROP2, HER2, GCC, GPC-3 and CEA, with expression intensity ≥ 2+;
Failed response to standard treatment or unwilling/intolerant to all standard treatment regimens;
Pregnant and lactating women; (The pregnancy test results are included in the CRF)
The patient can not guarantee effective contraceptive measures (such as condoms or birth control pills) within one year after enrollment;
Patients with brain metastases exhibiting significant psychiatric and neurological symptoms;
Serious heart diseases such as arrhythmia;
Single group
CAR-DC treatment
Biological/VaccineThe patients will receive intravenous injection (iv) of 30 million CAR-DC for two rounds at an interval of 14 days.
To evaluate the objective response rate (ORR) of CAR-DC therapy
The ORR is evaluated according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST1.1) .
To evaluate the disease control rate (DCR) of CAR-DC therapy
The DCR is evaluated according to RECIST1.1 criteria.
The quality of life assessment of CAR-DC therapy
The quality of life is evaluated according to the Eastern Cooperative Oncology Group (ECOG).
To evaluate the cytokine release syndrome (CRS) of CAR-DC therapy
The CRS is evaluated according to National Cancer Institute - the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (NCI CTCAE5.0).
To evaluate the neurotoxicity of CAR-DC therapy
Neurotoxicity is evaluated according to NCI CTCAE5.0
To evaluate the survival time of CAR-DC in patient peripheral blood
The survival time of CAR-DC in patient peripheral blood is analysed by flow cytometry of patient blood samples.
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