Clinical Study on the Safety and Efficacy of B7H3 CAR T Cells in Patients With B7H3 Positive Solid Tumors

Inclusion Criteria:

1. The patient fully understands the study procedures and voluntarily signs theinformed consent form.

2. Patients diagnosed with tumors that demonstrate positive B7H3 expression in tumortissues as confirmed by immunohistochemistry (IHC).

3. Presence of at least one extracranial lesion that is measurable according to theRECIST 1.1 criteria;

4. Estimated survival duration of ≥12 weeks;

5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1 atbaseline;

6. Recovery from prior treatment-related toxicities to a level below Grade 2.

7. Adequate hematopoietic and organ function without severe impairment;

8. Availability of suitable venous access for leukapheresis, with no contraindicationsto the collection of white blood cells.

Exclusion Criteria:

1. Patients with a history of or currently diagnosed with other malignant tumors;

2. Presence of brain metastases or clinically significant central nervous system (CNS)disorders;

3. Prior treatment within 14 days or five half-lives (whichever is longer) before bloodcollection for CAR-T preparation that may interfere with lymphocyte expansion;

4. HIV+，HBV，HCV，EBV，CMV.

5. Positive T-cell interferon-gamma release assay or sputum smear for tuberculosis;

6. Documented history or current evidence of pulmonary fibrosis, interstitialpneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, orsignificant pulmonary dysfunction;

7. History of severe allergic reactions or known hypersensitivity to any component ofthe investigational drugs used in the study;

8. Severe cardiovascular disease or uncontrolled refractory hypertension, unless deemedstable and non-interfering with the study by the investigator;

9. Severe hepatic or renal dysfunction, or presence of altered mental status;

10. Active autoimmune or inflammatory neurological disorders;

11. Presence of uncontrolled infections requiring systemic antibiotic, antifungal, orantiviral therapy;

12. Receipt of (attenuated) live vaccines within 4 weeks prior to screening;

13. Individuals with a history of alcohol dependence or substance abuse;

14. Pregnant or lactating women.