Phase
Condition
Neuroblastoma
Neoplasms
Treatment
GT201
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 1.Voluntarily enrolled in the study, signed an informed consent form, and willingand able to comply with the study protocol.
2.At least one lesion (preferably superficial lymph nodes) that has not been treatedwith radiation, has not received other local therapies, has access to tumor tissue,and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion sourceor multiple lesions combined) for the preparation of autologous tumor-infiltratinglymphocytes.
3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
Exclusion
Exclusion Criteria:
- 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression isnot eligible for enrollment.
2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Riskof major bleeding as assessed by investigators. 4.Have interstitial pneumonia orclinically significant active pneumonia at screening, or other respiratory diseasethat severely affects lung function.
5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy,history of autoimmune disease, or disease requiring systemic steroid hormone orimmunosuppressive drug therapy .
6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes,cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serumalbumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;
Study Design
Connect with a study center
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
ChinaActive - Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai 200072
ChinaSite Not Available

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