Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia

NCT06541444 | Recruiting Early Phase 1

• 1 other identifier: NK520-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity

  To evaluate the DLT during NK520 treatment

  From the first dose of NK520 to 4 weeks after last infusion of NK520

• Complete Response Rate (CRR)

  Effectiveness Metrics

  From the date of first infusion of NK520 up to 104 weeks.

Secondary Outcomes (4)

• Overall response rate (ORR)

  From the date of first infusion of NK520 up to 104 weeks.

• Event-Free Survival (EFS)

  From date of enrollment up to 104 weeks, or date of progression, or date of death, whichever came first.

• Overall Survival (OS)

  From date of enrollment up to 104 weeks or date of death, whichever came first.

• Duration of Response (DOR)

  From the date of enrollment up to 104 weeks

Study Arms (3)

Group A(low-dose group)

EXPERIMENTAL

NK520: 3×10\^7NK/kg

Drug: NK520

Group B(medium-dose group)

EXPERIMENTAL

NK520: 6×10\^7NK/kg

Drug: NK520

Group C(high-dose group)

EXPERIMENTAL

NK520: 9×10\^7NK/kg

Drug: NK520

Interventions

NK520 DRUG

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.

Also known as: genetic modified NK cell

Group A(low-dose group); Group B(medium-dose group); Group C(high-dose group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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/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:
• 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;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
• Expected survival of at least 12 weeks;
• Normal Organ Function.

You may not qualify 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 physiologic doses of systemic glucocorticoids (not exceeding 10 mg/day prednisone equivalent) for allergic reactions or for managing respiratory distress from asthma, COPD, etc;
• 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.

Sponsors & Collaborators

• Base Therapeutics (Shanghai) Co., Ltd.: lead
• Shanghai Pudong Hospital: collaborator

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201202, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• zhiguo Long

  Shanghai Pudong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yan

CONTACT

13817651474; yanjun@basetherapeutics.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation study

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: August 7, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)