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

ConditionRelapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBase Therapeutics (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be between 18 and 75 years;

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: Group A(low-dose group)Experimental treatment 1 intervention
Group B: Group B(medium-dose group)Experimental treatment 1 intervention
Group C: Group C(high-dose group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity

To evaluate the DLT during NK520 treatment

Time frame
From the first dose of NK520 to 4 weeks after last infusion of NK520
2

Complete Response Rate (CRR)

Effectiveness Metrics

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

Secondary outcomes

1

Overall response rate (ORR)

Effectiveness Metrics

Time frame
From the date of first infusion of NK520 up to 104 weeks.
2

Event-Free Survival (EFS)

Effectiveness Metrics

Time frame
From date of enrollment up to 104 weeks, or date of progression, or date of death, whichever came first.
3

Overall Survival (OS)

Effectiveness Metrics

Time frame
From date of enrollment up to 104 weeks or date of death, whichever came first.
4

Duration of Response (DOR)

Effectiveness Metrics

Time frame
From the date of enrollment up to 104 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Base Therapeutics (Shanghai) Co., Ltd.

Lead sponsor

Shanghai Pudong Hospital

Collaborator

Source ClinicalTrials.gov
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