Segurança e eficácia do NK520 para tratar leucemia mieloide aguda recidivante/refratária
Um estudo exploratório aberto e de centro único para avaliar a segurança e eficácia do NK520 para pacientes com leucemia mieloide aguda recidivante/refratária
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This open label, single-arm study aims to evaluate the efficacy and safety of allogenic natural killer (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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase inicial 1
Contactos e Locais
Locais de estudo
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 201202
- Shanghai Pudong Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Participants must be between 18 and 75 years;
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Diagnostic Criteria:
Meet the 2016 World Health Organization (WHO) diagnostic criteria for acute myelocytic leukemia (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;
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
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Expected survival of at least 12 weeks;
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Normal Organ Function.
Exclusion Criteria:
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Acute promyelocytic leukemia;
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Severe bleeding tendency or coagulation disorders, or currently receiving thrombolytic therapy;
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Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB within 1 year prior to the study;
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Human immunodeficiency virus (HIV)-infected individuals, or known active syphilis infection;
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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, chronic obstructive pulmonary disease (COPD), etc;
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Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study;
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Participation in another clinical trial and receipt of investigational drug within 4 weeks prior to the first dose;
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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;
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At screening, hepatitis B or C viral tests positive according to either:
- Hepatitis B surface antigen (HBsAg) positive with serum hepatitis B virus- deoxyribonucleic acid (HBV-DNA) titer ≥1×10^3 copies/mL or above normal limits;
- Hepatitis C virus (HCV) antibody positive;
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Any other condition or situation in which the investigator deems the patient unsuitable for participation in this study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group A(low-dose group)
NK520: 3×10^7NK/kg |
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.
Outros nomes:
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Experimental: Group B(medium-dose group)
NK520: 6×10^7NK/kg |
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.
Outros nomes:
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Experimental: Group C(high-dose group)
NK520: 9×10^7NK/kg |
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dose-Limiting Toxicity
Prazo: From the first dose of NK520 to 4 weeks after last infusion of NK520
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To evaluate the DLT during NK520 treatment |
From the first dose of NK520 to 4 weeks after last infusion of NK520
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Complete Response Rate (CRR)
Prazo: From the date of first infusion of NK520 up to 104 weeks.
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Effectiveness Metrics |
From the date of first infusion of NK520 up to 104 weeks.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Duration of Response (DOR)
Prazo: From the date of enrollment up to 104 weeks
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Effectiveness Metrics |
From the date of enrollment up to 104 weeks
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Overall response rate (ORR)
Prazo: From the date of first infusion of NK520 up to 104 weeks.
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Effectiveness Metrics |
From the date of first infusion of NK520 up to 104 weeks.
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Event-Free Survival (EFS)
Prazo: From date of enrollment up to 104 weeks, or date of progression, or date of death, whichever came first.
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Effectiveness Metrics |
From date of enrollment up to 104 weeks, or date of progression, or date of death, whichever came first.
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Overall Survival (OS)
Prazo: From date of enrollment up to 104 weeks or date of death, whichever came first.
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Effectiveness Metrics |
From date of enrollment up to 104 weeks or date of death, whichever came first.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: zhiguo Long, Shanghai Pudong Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NK520-02
Plano para dados de participantes individuais (IPD)
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