Status:
RECRUITING
Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Base Therapeutics (Shanghai) Co., Ltd.
Collaborating Sponsors:
Shanghai Children's Medical Center
Conditions:
Relapsed/Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
6-18 years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
This open label, single-arm study aims to evaluate the efficacy and safety of allogenic NK cells in pediatric relapsed/refractory acute myeloid leukemia. Allogenic NK cells will be infused once a week...
Eligibility Criteria
Inclusion
- Participants must be between 6 and 18 years;
- Diagnostic Criteria: Meet the 2022 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: a. 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; b. 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;
- For participants under 16 years old, Lansky performance status must be ≥50%; for participants aged 16 or older, Karnofsky performance status must be ≥50%;
- Expected survival of at least 12 weeks;
- Normal Organ Function.
Exclusion
- 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 tendency or coagulation disorders, or currently receiving thrombolytic therapy;
- HIV-infected individuals, or individuals with known active syphilis infection;
- Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study period;
- Participation in another clinical trial and receipt of investigational drug within 4 weeks prior to the first dose;
- Receipt of immune-modulatory drugs (including thymosin, interferons, except for local use to manage conditions like pleural or ascites fluid) within 2 weeks before the first dose;
- At screening, positive hepatitis B or C viral markers as follows:
- HBsAg positive with serum HBV-DNA level ≥1×10\^3 copies/mL or above normal range;
- Positive for HCV antibodies;
- Any other condition or situation in which the investigator deems the patient unsuitable for participation in this study.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06541405
Start Date
July 1 2024
End Date
June 1 2025
Last Update
August 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127