TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma

Exclusion Criteria

• •Patients who were judged by the investigator to require long-term immunosuppressive therapy at the time of screening
• •Cerebrovascular accident or seizure occurred within 6 months before signing the informed consent
• •Malignant tumors other than neuroblastoma, excluding carcinoma in situ
• •Hepatitis B surface antigen (HBsAg) positive; hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood type C Hepatitis virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive
• •Serious cardiac disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade III), severe arrhythmia
• •Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy
• •Presence of chronic progressive neurological disease
• •Patients who have not recovered from acute toxic effects of prior treatment
• •Active or uncontrolled infection requiring systemic treatment (except mild urogenital and upper respiratory tract infections)
• •Pregnancy-capable female subjects who plan to become pregnant within 2 years of cell reinfusion; or male subjects whose partners plan to become pregnant within 2 years of cell reinfusion
• •Those who have received CAR-T therapy or other gene-modified cell therapy before screening
• •Participated in other clinical studies within 1 month before screening
• •Subjects screened for evidence of central nervous system involvement
• •For patients with liver metastases, the distribution of liver metastases exceeds 1/2 of the liver
• •According to the judgment of the investigators, it does not meet the situation of cell preparation
• •Other circumstances deemed inappropriate by investigators