The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple 4SCAR-T cell therapy which targets GD2, PSMA and CD276 surface antigens in patients with relapsed and refractory neuroblastoma (NB). Another goal of the study is to understand the function of the multi-CAR-T cells and their persistency in the patients.
Patients with tumors have received standard first-line therapy and been judged to be non-resectable, metastatic, progressive or recurrent.
The expression status of GD2, PSMA and CD276 antigens of the tumor will be determined for eligibility. Positive expression is defined by GD2, PMSA and CD276 antibody staining results based on immunohistochemistry or flow cytometry analyses.
Body weight greater than or equal to 10 kg.
Age: ≥1 year and ≤ 65 years of age at the time of enrollment.
Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity.
Untreated central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible.
Previous treatment with other genetically engineered GD2, PSMA and CD276 CART cells.
Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
Single group
GD2, PSMA and CD276 CAR-T cells
Biological/Vaccineinfusion, for 1x10\^6\~1x10\^7 cells/kg via IV
Number of patients with adverse events
Determine the toxicity profile the GD2, PSMA and CD276 4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0
Anti-tumor effects
Complete response/remission (CR), Very good partial response/remission (VGPR) will be assessed by the image scan
The expansion of CAR-T cells
The investigators will monitor the expansion of GD2, PSMA and CD276 CAR-T cells in the peripheral blood of patients and the correlation with antitumor effects.
The anti-tumor activity after CAR-T infusions
The anti-tumor activity of lymphocytes will be assessed
The cytokine secretion profile after CAR-T infusions
The cytokine secretion profile of lymphocytes will be assessed.
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This trial is not recruiting at the moment. You can still explore other options:
