A Study on the Efficacy of GD2-CAR T Cells in the Treatment of Neuroblastoma

Inclusion Criteria:

1. All cases were diagnosed as neuroblastoma with positive expression of GD2 antigen intumor cells. Informed consent of patient or guardian.

2. Diagnosis of recurrent/refractory neuroblastoma.

3. At least 2 weeks or 5 half-lives (whichever is shorter) from the beginning ofpreconditioning chemotherapy after prior systemic treatment.

4. Toxic reactions caused by previous antitumor therapy must be stabilized and restoredto ≤ grade 1.

5. Over 1 years old, under 18 years old.

6. Physical strength score 0-3 (ECOG standard).

7. No obvious active infection.

8. Expected survival ≥3 months

9. Adequate kidney, liver, lung and heart function, defined as creatinine clearance (estimated by the Cockcroft Gault formula) > 60 mL/min; Serum ALT/AST ≤ 2.5 ULN;Total bilirubin ≤1.5 ULN, excluding subjects with Gilbert's syndrome; Cardiacejection fraction ≥ 50%, echocardiography confirmed centropericardial effusion, andECG showed no clinically significant abnormal findings. There was no clinicallysignificant pleural effusion. Baseline blood oxygen saturation under indoorventilation was > 92%.

10. The serum pregnancy test results of fertile women must be negative (women who haveundergone surgical sterilization or at least 2 years after menopause are consideredto be infertile).

Exclusion Criteria:

1. The subject has had other malignancies, non-melanoma skin tumors, carcinoma in situ (e.g. Cervix, bladder, breast), unless disease-free survival of at least 3 years.

2. There is an uncontrollable infection, including fungal, bacterial, viral or other.

3. Known human immunodeficiency virus (HIV) infection.

4. Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibodypositive). Subjects with latent or prehepatitis B infection (defined as HBcAbpositive and HBsAg negative) can be enrolled only if PCR tests for HBV DNA arenegative. In addition, these subjects were required to undergo a monthly PCR testfor HBV DNA. Participants who are serologically positive for HCV antibodies can alsobe enrolled if their PCR test results for HCV RNA are negative.

5. Existing or past CNS disease, such as seizures, cerebrovascular ischemia/bleeding,dementia, cerebellar disease, or any CNS-related autoimmune disease.

6. Serious heart disease, such as uncontrolled or symptomatic arrhythmia, congestiveheart failure, or myocardial infarction within 6 months prior to screening, or anygrade 3 (moderate) or 4 (severe) heart disease (according to the New York HeartSociety Functional Grading Method NYHA).

7. A history of myocardial infarction, angioplasty or stent placement, unstable anginapectoris, or other clinically significant heart disease in the 12 months prior toenrollment.

8. Any medical condition that may affect the evaluation of safety or efficacy.

9. Have had severe rapid hypersensitivity reactions to any of the drugs to be used inthis study.

10. Live vaccine should be administered within ≤6 weeks before starting the pretreatmentregimen.

11. Pregnant or lactating female subjects.

12. Male or female subjects who do not consent to effective contraception from the timethey sign informed consent until 6 months after completing immune cell therapy.

13. Subjects judged by the investigator had difficulty in completing all visits orprocedures required by the study protocol (including follow-up visits), or were notcompliant enough to participate in the study.