Sécurité et efficacité du NK520 pour traiter la leucémie myéloïde aiguë récidivante/réfractaire
Une étude exploratoire ouverte et monocentrique pour évaluer l'innocuité et l'efficacité du NK520 chez les patients atteints de leucémie myéloïde aiguë récidivante/réfractaire
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 201202
- Shanghai Pudong Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dose-Limiting Toxicity
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Duration of Response (DOR)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: zhiguo Long, Shanghai Pudong Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NK520-02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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