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Tests treatment safety and results for Relapsed/Refractory Acute Myeloid Leukemia
Official title Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06541444
What this study is testing
What is NK520?
NK520 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for relapsed/refractory acute myeloid leukemia.
Also referred to as genetic modified NK cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants must be between 18 and 75 years;
- Diagnostic Criteria: Meet the 2016 World Health Organization (WHO) diagnostic criteria for AML, unsuitable for current treatments or patients with...
- Relapsed AML: Diagnosis is confirmed when leukemia cells reappear in the peripheral blood or bone marrow blast cells exceed 5% after complete...
- Refractory AML: Initial cases unresponsive after two cycles of standard regimen treatment; recurrence within 12 months after CR and consolidation...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
You likely can't join if
- Acute promyelocytic leukemia;
- Severe bleeding tendency or coagulation disorders, or currently receiving thrombolytic therapy;
- Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB within 1 year prior to the study;
- HIV-infected individuals, or known active syphilis infection;
- Use of immunosuppressive drugs within 1 week before the first dose, excluding topical, inhaled, or other locally administered glucocorticoids, or...
- Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study;
See the full eligibility criteria
- Participants must be between 18 and 75 years;
- 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 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- Expected survival of at least 12 weeks;
- Normal Organ Function.
- Acute promyelocytic leukemia;
- Severe bleeding tendency or coagulation disorders, or currently receiving thrombolytic therapy;
- Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB within 1 year prior to the study;
- HIV-infected individuals, or known active syphilis infection;
- 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...
- Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study;
- Participation in another clinical trial and receipt of investigational drug within 4 weeks prior to the first dose;
- 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;
- 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;
- Any other condition or situation in which the investigator deems the patient unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.