This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, preliminary efficacy, pharmacokinetics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with relapsed/refractory Neuroblastoma.
Aged 1-12 years with weight≥10kg, male or female;
The child and/or guardian has signed the informed consent form (ICF) and has the ability to comply with the study requirements.
Relapsed neuroblastoma: New lesions appear at the primary site or other locations 4 weeks after achieving complete remission through first-line standard treatment.
Refractory neuroblastoma: Failure to achieve complete remission after standard treatment protocols, which include induction chemotherapy, surgery, and radiotherapy targeting the primary tumor and residual metastatic sites;
Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and / or radical resection of carcinoma in situ.
Participants with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination.
Participants with MIBG non-avid disease.
Participants with a history of organ transplantation（excluding stem cell transplantation）;
Nanjing Children's Hospital
Lead sponsor
Nanjing Medical University
Sponsor institution