Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors

Inclusion Criteria:

1. The patient understands and voluntarily signs the informed consent form, and isexpected to complete the follow-up examination and treatment of the studyprocedures;

2. Age 18-75 years old, gender unlimited;

3. Tumor patients who have positive expression of CDH17 target in tumor tissuesmeasured by immunohistochemistry (IHC) in a laboratory approved by the partner, andhave no standard therapy or are ineffective or not suitable for standard treatment;

4. Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;

5. Estimated survival ≥ 12 weeks;

6. Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point;

7. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAEtoxicity grade < 2 (unless the abnormality is related to the tumor or is stable asjudged by the investigator and has little impact on safety or efficacy);

8. Venous access could be established; without contraindications of apheresis.

Exclusion Criteria:

1. Patients with prior or current other malignancies;

2. Presence of brain metastases and clinically significant central nervous systemdisease;

3. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targetedtherapy, epigenetic therapy, or investigational drug therapy within 14 days or atleast 5 half-lives, whichever is shorter;

4. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer ishigher than the lower limit of detection of the research institution; HCV antibodypositive; HIV antibody positive; CMV DNA titer is higher than the lower limit ofdetection of the research institution; EBV DNA titer is higher than the lower limitof detection of the research institution

5. Those who have a positive sputum smear and T-cell test for tuberculosis infection;

6. Patients with objective evidence of a history of pulmonary fibrosis, interstitialpneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severeimpairment of lung function, both past and present;

7. Patients have a severe allergic history;

8. Patients with severe heart disease or uncontrollable refractory hypertension;

9. Patients with severe liver and kidney dysfunction or consciousness disorders;

10. Active autoimmune or inflammatory diseases of the nervous system;

11. Uncontrolled infections that need antibiotics treatment;

12. Live attenuated vaccine within 4 weeks before screening;

13. Alcoholics or persons with a history of drug abuse;

14. Pregnant or Lactating Women; Patients and his or her spouse have a fertility planwithin two years after CAR-T cell infusion;

15. Any unsuitable to participate in this trial judged by the investigator.