Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
Recruiting now · Early Phase 1
Conditions studied: Relapsed/Refractory Acute Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT06541444
- Run by
- Base Therapeutics (Shanghai) Co., Ltd.
- People needed
- 9
- Starts
- 2024-07-01
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2024-08-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must be between 18 and 75 years;
- 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:
- 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;
- Expected survival of at least 12 weeks;
- Normal Organ Function.
You may not qualify if…
- 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;
- 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;
- Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study;
- Participation in another clinical trial and receipt of investigational drug within 4 weeks prior to the first dose;
- 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;
- 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;
- Any other condition or situation in which the investigator deems the patient unsuitable for participation in this study.
Where it is running
- Shanghai Pudong Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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