Actively Recruiting
Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
Led by Base Therapeutics (Shanghai) Co., Ltd. · Updated on 2024-08-07
9
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
B
Base Therapeutics (Shanghai) Co., Ltd.
Lead Sponsor
S
Shanghai Children's Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the safety and efficacy of NK520 in the treatment of pediatric 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 Pediatric Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 6 and 18 years
- Diagnosed with acute myeloid leukemia (AML) according to 2022 WHO criteria, relapsed or refractory after at least two prior therapies
- For participants under 16 years, Lansky performance status of 50% or higher; for those 16 or older, Karnofsky performance status of 50% or higher
- Expected survival of at least 12 weeks
- Normal organ function
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia, chronic myeloid leukemia, acute mixed lineage leukemia, or known central nervous system leukemia
- AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome, or congenital aplastic anemia
- Severe bleeding or coagulation disorders or currently receiving thrombolytic therapy
- HIV infection or known active syphilis infection
- Received live attenuated vaccines within 2 weeks before first dose or planned during study
- Participation in another clinical trial with investigational drug within 4 weeks before first dose
- Received immune-modulatory drugs (e.g., thymosin, interferons except local use) within 2 weeks before first dose
- Positive hepatitis B or C viral markers with specific viral load criteria
- 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 Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here