NCT06541405 Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
| NCT ID | NCT06541405 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Base Therapeutics (Shanghai) Co., Ltd. |
| Condition | Relapsed/Refractory Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-06-01 |
Trial Parameters
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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 efficacy of this treatment will be evaluated.
Eligibility Criteria
Inclusion Criteria: 1. Participants must be between 6 and 18 years; 2. 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 extrame
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