Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBase Therapeutics (Shanghai) Co., Ltd.
About this trial
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 criteria
Qualifiers
Participants must be between 18 and 75 years;
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;
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;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
Disqualifiers
Acute promyelocytic leukemia;
Severe bleeding tendency or coagulation disorders, or currently receiving thrombolytic therapy;
Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB within 1 year prior to the study;
HIV-infected individuals, or known active syphilis infection;
Trial design
Treatments tested in this trial
- NK520
Treatment groups
9 Participants
are divided into 3 treatment groupsSponsors and collaborators
Base Therapeutics (Shanghai) Co., Ltd.
Lead sponsor
Shanghai Pudong Hospital
Collaborator
Source ClinicalTrials.gov