Leukemia Clinical Trials

∙ According to the WHO disease classification, patients with relapsed/refractory T - lymphoma and acute myeloid leukemia:

• Voluntarily participate in this study and sign the informed consent form;

• Aged between 18-75 years old, both male and female are eligible;

• Relapsed/refractory T cell lymphoma is defined as: relapsed/refractory after having received at least two or more lines of previous treatment (patients with anaplastic large -cell lymphoma must have been exposed and resistant to Brentuximab vedotin). The celluar subtypes of T-cell lymphoma include: angioimmunoblastic T-cell lymphoma; peripheral T - cell lymphoma not otherwise specified; ALK-negative anaplastic large - cell lymphoma; Relapsed/refractory AML is defined as: leukemia cells reappear in the peripheral blood after complete remission or the blasts in the bone marrow ≥ 5% or the extramedullary leukemia infiltration outside. Or newly diagnosed cases did not achieve a CR after two courses of standard regimens; those who relapse within 12 months after CR after consolidation and intensification treatment; those who relapse after 12 months and have not responded to conventional chemotherapy; those who relapse two or more times; those with persistent extramedullary leukemia;

• The expected survival period ≥ 12 weeks;

• CD70 expression is positive in tumor tissue puncture sections/tumor cells detected by flow cytometry, and the number of CD70 - positive cells detected by immunohistochemistry ≥ 20% (++ or more);

• ECOG score is 0 - 2;

• Adequate organ function reserve:

‣ Alanine aminotransferase and aspartate aminotransferase ≤ 2.5× UNL;

⁃ Creatinine clearance rate (Cockcroft - Gault method) ≥ 60 mL/min;

⁃ Serum total bilirubin and alkaline phosphatase ≤ 1.5× UNL;

⁃ Glomerular filtration rate \> 50 ml/min;

⁃ Cardiac ejection fraction ≥ 45%;

⁃ Under indoor natural air environment, the basic oxygen saturation \> 92%;

⁃ Routine blood test: absolute neutrophil count \> 1000/mm3, platelet count ≥ 45×109, hemoglobin ≥ 8.0g/dl (the standard for AML patients is ≥ 7.0g/dl; blood transfusion is allowed);

• Previous autologous hematopoietic stem cell transplantation is allowed once;

• Patients who have previously received CAR - T cell therapy and were evaluated as ineffective after 3 months or relapsed after CR are allowed;

⁃ Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial period;

⁃ No active lung infection, and indoor air blood oxygen saturation ≥ 92%;

⁃ Before the study drug is used, approved anti - tumor treatment methods, such as systemic chemotherapy, whole - body radiotherapy, and immunotherapy, have been completed for at least 3 weeks; the wash - out period for targeted drug regimens without chemotherapy is 2 weeks;

⁃ Two negative tests for COVID - 19 or influenza A.