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Trial Title:
Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT06541444
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 will be calculated based on body weight
of subject. NK520 should be administered through intravenous infusion once a week, for a
total of four times.
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
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 subjects with 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 18 and 75 years;
2. Diagnostic Criteria:
Meet the 2016 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:
1. 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;
2. 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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
4. Expected survival of at least 12 weeks;
5. Normal Organ Function.
Exclusion Criteria:
1. Acute promyelocytic leukemia;
2. Severe bleeding tendency or coagulation disorders, or currently receiving
thrombolytic therapy;
3. Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB
within 1 year prior to the study;
4. HIV-infected individuals, or known active syphilis infection;
5. Use of immunosuppressive drugs within 1 week before the first dose, excluding
topical, inhaled, or other locally administered glucocorticoids, or physiologic
doses of systemic glucocorticoids (not exceeding 10 mg/day prednisone equivalent)
for allergic reactions or for managing respiratory distress from asthma, COPD, etc;
6. Receipt of live attenuated vaccines within 2 weeks before the first dose or planned
during the study;
7. Participation in another clinical trial and receipt of investigational drug within 4
weeks prior to the first dose;
8. Receipt of immune-modulating drugs (including thymosin, interferons, except for
local use to control pleural or ascitic fluid) within 2 weeks prior to the first
dose;
9. At screening, hepatitis B or C viral tests positive according to either:
- HBsAg positive with serum HBV-DNA titer ≥1×10^3 copies/mL or above normal
limits;
- HCV antibody positive;
10. Any other condition or situation in which the investigator deems the patient
unsuitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pudong Hospital
Address:
City:
Shanghai
Zip:
201202
Country:
China
Status:
Recruiting
Contact:
Last name:
Minghua Yu
Phone:
18017821601
Email:
minghuamd@fudan.edu.cn
Start date:
July 1, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Base Therapeutics (Shanghai) Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Shanghai Pudong Hospital
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/NCT06541444
