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Trial Title:
Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT06541405
Condition:
Relapsed/Refractory Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Dose escalation study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NK520
Description:
The number of NK520 cell infused for each dosing should be calculated base on the body
weight of subject. NK520 will be administered through intravenous infusion.
Arm group label:
Group A(low-dose group)
Arm group label:
Group B(medium-dose group)
Arm group label:
Group C(high-dose group)
Other name:
genetic modified NK cell
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.
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. After infusion, the investigators will observe the
characteristics of dose limited toxicity (DLT), and determine the maximum tolerable
dose(MTD). To provide basis for the dosage and treatment plan of cell products in
follow-up clinical trials.
Criteria for 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 extramedullary leukemia;
3. For participants under 16 years old, Lansky performance status must be ≥50%; for
participants aged 16 or older, Karnofsky performance status must be ≥50%;
4. Expected survival of at least 12 weeks;
5. Normal Organ Function.
Exclusion Criteria:
1. Acute promyelocytic leukemia, chronic myeloid leukemia, acute mixed lineage
leukemia, or known central nervous system leukemia;
2. AML associated with congenital syndromes, such as Down syndrome, Fanconi anemia,
Bloom syndrome, Kostmann syndrome, or congenital aplastic anemia;
3. Severe bleeding tendency or coagulation disorders, or currently receiving
thrombolytic therapy;
4. HIV-infected individuals, or individuals with known active syphilis infection;
5. Receipt of live attenuated vaccines within 2 weeks before the first dose or planned
during the study period;
6. Participation in another clinical trial and receipt of investigational drug within 4
weeks prior to the first dose;
7. 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;
8. 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;
9. Any other condition or situation in which the investigator deems the patient
unsuitable for participation in this study.
Gender:
All
Minimum age:
6 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Children's Medical Center
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenting Hu
Phone:
13524836748
Email:
yanjun@basetherapeutics.com
Start date:
July 1, 2024
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Base Therapeutics (Shanghai) Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Shanghai Children's Medical Center
Agency class:
Other
Source:
Base Therapeutics (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541405
