Single-center, Open, One-arm Clinical Study of the Safety and Efficacy of Anti-CD56-CAR T Therapy in Relapsed Refractory NK/T Cell Lymphoma /NK Cell Leukemia
To evaluate the safety and efficacy of anti-CD56-CAR T in the treatment of relapsed refractory NK/T cell lymphoma /NK cell leukemia
• Patients or their legal guardians voluntarily participate and sign the informed consent;
• Male or female patients aged 18-70 years (including 18 and 70 years);
• The patient was diagnosed as NK/T cell lymphoma /NK cell leukemia by pathology or flow cytometry, and currently has no effective treatment options, such as relapse after chemotherapy or hematopoietic stem cell transplantation; Alternatively, patients voluntarily choose to administer anti-CD56-CAR T cells as salvage therapy.
• The following two categories are included:(1)NK/T cell lymphoma;(2) NK cell leukemia.
• Subject:
⁃ (1)There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable; (2)Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable; (3)Patients with high risk factors; (4)Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
⁃ 6\. Measurable or evaluable lesions;
⁃ 7\. The patient's main tissues and organs function well:
• Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
• Renal function: creatinine \< 220 μmol/L;
• Lung function: indoor oxygen saturation ≥95%;
• Cardiac function: left ventricular ejection fraction (LVEF) ≥40%.
⁃ 8\. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss);
⁃ 9\. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion;
⁃ 10\. Patients with ECOG score ≤2 and expected survival time ≥3 months.