Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia

Summary

This study will evaluate the safety and efficacy of NK520 in the treatment of relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.

Eligibility

Inclusion Criteria:

1. Participants must be between 18 and 75 years;
2. Diagnostic Criteria:

   Meet the 2016 World Health Organization (WHO) diagnostic criteria for AML, unsuitable for current treatments or patients with relapsed/refractory AML after ≥2 lines of therapy. The definition of relapsed/refractory acute myeloid leukemia is based on the 2017 Chinese Guidelines for Diagnosis and Treatment:
   1. Relapsed AML: Diagnosis is confirmed when leukemia cells reappear in the peripheral blood or bone marrow blast cells exceed 5% after complete remission (CR) (excluding reasons such as bone marrow regeneration post-consolidation chemotherapy) or there is extramedullary infiltration by leukemia cells;
   2. Refractory AML: Initial cases unresponsive after two cycles of standard regimen treatment; recurrence within 12 months after CR and consolidation therapy; recurrence beyond 12 months with ineffectiveness of conventional chemotherapy; those who have relapsed twice or more; or persistent extramedullary leukemia;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
4. Expected survival of at least 12 weeks;
5. Normal Organ Function.

Exclusion Criteria:

1. Acute promyelocytic leukemia;
2. Severe bleeding tendency or coagulation disorders, or currently receiving thrombolytic therapy;
3. Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB within 1 year prior to the study;
4. HIV-infected individuals, or known active syphilis infection;
5. Use of immunosuppressive drugs within 1 week before the first dose, excluding topical, inhaled, or other locally administered glucocorticoids, or physiologic doses of systemic glucocorticoids (not exceeding 10 mg/day prednisone equivalent) for allergic reactions or for managing respiratory distress from asthma, COPD, etc;
6. Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study;
7. Participation in another clinical trial and receipt of investigational drug within 4 weeks prior to the first dose;
8. Receipt of immune-modulating drugs (including thymosin, interferons, except for local use to control pleural or ascitic fluid) within 2 weeks prior to the first dose;
9. At screening, hepatitis B or C viral tests positive according to either:

   * HBsAg positive with serum HBV-DNA titer ≥1×10\^3 copies/mL or above normal limits;
   * HCV antibody positive;
10. Any other condition or situation in which the investigator deems the patient unsuitable for participation in this study.

Conditions2

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