Actively Recruiting
Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
Led by Base Therapeutics (Shanghai) Co., Ltd. · Updated on 2024-08-07
9
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
B
Base Therapeutics (Shanghai) Co., Ltd.
Lead Sponsor
S
Shanghai Pudong Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 18 and 75 years
- Meet 2016 WHO diagnostic criteria for AML and be unsuitable for current treatments or have relapsed/refractory AML after at least two lines of therapy
- Relapsed AML defined as leukemia cells reappearing in blood or bone marrow blasts over 5% after remission, or extramedullary leukemia
- Refractory AML defined as no response after two cycles of standard treatment, or recurrence within 12 months after remission and consolidation, or multiple relapses, or persistent extramedullary leukemia
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival of at least 12 weeks
- Normal organ function
You will not qualify if you...
- Acute promyelocytic leukemia diagnosis
- Severe bleeding tendency or coagulation disorders, or current thrombolytic therapy
- Active tuberculosis or anti-TB treatment within 1 year
- HIV infection or active syphilis
- Use of immunosuppressive drugs within 1 week before first dose, except certain glucocorticoids
- Receipt of live attenuated vaccines within 2 weeks before first dose or planned during study
- Participation in another clinical trial and receipt of investigational drug within 4 weeks before first dose
- Use of immune-modulating drugs within 2 weeks prior to first dose, except local treatments for pleural or ascitic fluid
- Positive hepatitis B (HBsAg positive with high HBV-DNA) or hepatitis C tests
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, China, 201202
Actively Recruiting
Research Team
J
Jun Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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