Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/refractory Acute Myeloid Leukemia (AML)or Blastic Plasmacytoid Dendritic Cell Neoplasm(BPDCN)
This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed/refractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.
⁃ Patients of any gender, aged between 18 and 75 years (inclusive);
⁃ Positive expression of CD123 on tumor cells detected by flow cytometry;
⁃ Patients with a confirmed diagnosis of CD123-positive relapsed/refractory AML or BPDCN:
• (1) For AML patients：
• Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemic cell infiltration outside the marrow;
• Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and consolidation/intensification therapy; patients who have relapsed after 12 months but have not responded to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;
• (2) For BPDCN patients: Patients who have not responded to or cannot tolerate the recommended salvage treatment according to guidelines, and have persistent or recurrent disease in any of the following: peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other sites.
• 4\. Expected survival time of more than 12 weeks;
• 5\. ECOG score of 0-2 (Appendix 2);
• 6\. No severe mental disorders;
• 7\. Basic normal function of important organs:
‣ Blood routine: white blood cells \>1.0×109/L, neutrophils \>0.5×109/L, lymphocytes \>0.5×109/L, platelets \>50×109/L;
‣ Cardiac function: echocardiography indicates a left ventricular ejection fraction ≥50%, and no significant abnormalities on electrocardiogram;
‣ Renal function: serum creatinine ≤2.0×ULN;
‣ Liver function: ALT and AST ≤3.0×ULN (for patients with liver invasion
∙ 5.0×ULN);
‣ Total bilirubin ≤2.0×ULN (for patients with Gilbert's syndrome ≤3.0×ULN);
‣ Blood oxygen saturation \>92%. 8. The patient or their legal guardian agrees to participate in this clinical trial and signs the ICF, indicating their understanding of the purpose and procedures of the clinical trial and willingness to participate in the study.