Using NK520 to treat difficult cases of acute myeloid leukemia

An Open, Single Center Exploratory Study to Evaluate Safety and Efficacy of NK520 for Patients With Relapsed/Refractory Acute Myeloid Leukemia

This study is testing a new treatment using NK520 cells to see if it can help people with tough cases of relapsed or refractory acute myeloid leukemia feel better.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Base Therapeutics (Shanghai) Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06541444 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm study evaluates the safety and efficacy of allogenic NK520 cells administered via intravenous injection in patients with relapsed or refractory acute myeloid leukemia (AML). Participants will receive weekly infusions of NK520, and the study will monitor for dose-limiting toxicity and determine the maximum tolerable dose. The findings aim to inform future clinical trials regarding dosage and treatment plans for this innovative therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory acute myeloid leukemia who have failed at least two lines of therapy.

Not a fit: Patients with acute myeloid leukemia who are not relapsed or refractory, or those who have not undergone prior treatments, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory acute myeloid leukemia.

How similar studies have performed: While the use of NK cells in cancer treatment is a growing field, this specific approach with NK520 is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Pudong Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: zhiguo Long — Shanghai Pudong Hospital
• Study coordinator: Jun Yan

Conditions: Relapsed/Refractory Acute Myeloid Leukemia