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

Inclusion Criteria:

• Age ≥ 1 year (including cut-off value), gender is not limited
• Expected survival time ≥ 3 months
• Karnofsky score (> 16 years) or Lansky score (≤ 16 years) > 60 points
• Meet the clinical diagnostic criteria and be diagnosed as recurrent / refractoryneuroblastoma. For first-line standard treatment, please refer to the consensus ofexperts in the diagnosis and treatment of Pediatric Neuroblastoma (Chinese Journal ofPediatric surgery, Volume 36, No. 1, 2015), the guidelines for the diagnosis andtreatment of Pediatric Neuroblastoma of 2019 by the Health Commission, and theconsensus of experts in the diagnosis and treatment of Pediatric Neuroblastoma (CCCG-NB-2021 Program) (Chinese Journal of Pediatric surgery, Volume 43, No. 7, 2022)

1. Recurrence is defined as the determination of recurrence after remission after atleast first-line standard treatment.
2. Refractory is defined as a person who is not in remission after at least 4 cyclesof chemotherapy (≥ 2 chemotherapeutic drugs, including alkylating agents andplatinum)

• The tumor tissue samples of the subjects were stained by immunohistochemistry (IHC) toshow that the expression intensity of B7-H3 on the surface of tumor cell membranes was 1+ or above, and the proportion of positive staining of tumor cell membranes was ≥1%
• At least one measurable lesion defined by RECISTv1.1 criteria, and at least one lesionthat can be irradiated (except bone marrow)
• Subjects with lesions only in the bone marrow may also be enrolled (withoutirradiation)
• Liver and kidney function, cardiopulmonary function must meet the followingrequirements:

1. Total bilirubin ≤ 3 × ULN;ALT and AST ≤ 5 × ULN
2. Creatinine≤2 ULN
3. Left ventricular ejection fraction ≥ 50%
4. Blood oxygen saturation ≥ 92%

• Patients and/or their guardians understand the trial and have signed informed consent

Exclusion Criteria:

• Patients who were judged by the investigator to require long-term immunosuppressivetherapy at the time of screening
• Cerebrovascular accident or seizure occurred within 6 months before signing theinformed 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 withinthe normal reference range; hepatitis C virus (HCV) antibody positive and peripheralblood 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, myocardialinfarction (within 6 months prior to screening), congestive heart failure (New YorkHeart Association [NYHA] classification ≥ grade III), severe arrhythmia
• Unstable systemic disease as judged by the investigator: including but not limited tosevere 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 urogenitaland upper respiratory tract infections)
• Pregnancy-capable female subjects who plan to become pregnant within 2 years of cellreinfusion; or male subjects whose partners plan to become pregnant within 2 years ofcell reinfusion
• Those who have received CAR-T therapy or other gene-modified cell therapy beforescreening
• 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 1/2of the liver
• According to the judgment of the investigators, it does not meet the situation of cellpreparation
• Other circumstances deemed inappropriate by investigators