Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer

Inclusion Criteria:

1. No gender limitation, age 18-75 years old (including boundary value);
2. Late, metastatic, or recurrent malignant tumors that have received at least first-linestandard treatment failure (progressive or intolerable disease, such as surgery,chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment, andthe tumor CEA positive expression (tumor CEA positive or serum CEA level> 50ng / mlconfirmed by histology or pathology);
3. There are measurable and assessable lesions: the diameter of the lesion under CT orMRI scan is greater than 0.5cm;
4. The expected survival time is more than 12 weeks;
5. KPS≥60 ;
6. No serious mental disorders;
7. The functions of important organs are basically normal:
8. Blood routine: white blood cells> 2.0 × 10^9 / L, neutrophils> 0.8 × 10^9 / L,lymphocytes> 0.5 × 10^9 / L, platelets> 50 × 10^9 / L, hemoglobin> 90g / L;
9. Cardiac function: cardiac ultrasound indicates that the cardiac ejection fractionis ≥50%, and there is no obvious abnormality on the electrocardiogram;
10. Renal function: serum creatinine and urea nitrogen ≤3.0 × ULN;
11. Liver function: ALT and AST ≤5.0 × ULN; total bilirubin ≤3.0 × ULN;
12. Blood oxygen saturation> 92%.
13. There are no other serious diseases that conflict with this plan (such as autoimmunediseases, immunodeficiency, organ transplantation);
14. There are no contraindications for apheresis or intravenous blood collection or othercell collection;
15. The patient or his guardian agrees to participate in this clinical trial and sign theICF, indicating that he understands the purpose and procedures of this clinical trialand is willing to participate in the study.

Exclusion Criteria:

1. Have received CAR-T treatment or other genetically modified cell treatment beforescreening;
2. Participated in other clinical studies within 1 month before screening;
3. Received the following anti-tumor treatment before screening: received chemotherapy,targeted therapy or other experimental drug treatment within 4 weeks, except for thosewho have confirmed disease progression after treatment;
4. Have received live attenuated vaccine within 4 weeks before screening;
5. Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
6. Suffering from any of the following heart diseases:
7. New York Heart Association (NYHA) stage III or IV congestive heart failure;
8. Myocardial infarction occurred or received coronary artery bypass graft (CABG) ≤6months before enrollment;
9. Clinically significant ventricular arrhythmias, or history of syncope of unknowncause (except for conditions caused by vasovagal or dehydration);
10. Severe cardiac insufficiency, severe heart valve disease and other cardiovascularsystem diseases;
11. There are active infections or uncontrollable infections requiring systemic treatmentwithin 2 weeks before screening;
12. Active autoimmune diseases;
13. Suffering from chronic enteritis and / or intestinal obstruction;
14. Suffering from other malignant tumors, in addition to fully treated cervical carcinomain situ, basal cell or squamous cell skin cancer, local prostate cancer after radicalresection, and ductal carcinoma in situ after radical resection;
15. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive andperipheral blood hepatitis B virus (HBV) DNA titer detection is greater than thenormal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitisC Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
16. Women who are pregnant or breastfeeding;
17. The situation that other researchers think is not suitable for participating in thestudy.