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Активно (без набиране) Фаза 2 NCT04414163

A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Extranodal NK/T-cell Lymphoma, Nasal Type Extranodal NK/T-cell Lymphoma

Спонсор: ImmuneOncia Therapeutics Inc.

Налично на: БГ
Обобщение
This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type
Описание
IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.
Кой може да участва
Inclusion Criteria: 1. ENKTL diagnosis; * Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type * At least 1 previous line of systemic therapy * Documented disease progression of last therapy 2. Adult age(as defined by respective country) 3. The nature of the study and voluntarily sign an ICF 4. ECOG 0 or1 5. Adequate hematologic function, hepatic function, and renal function Exclusion Criteria: 1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody 2. Known presence of symptomatic CNS metastases 3. Prior allogeneic HSCT or solid organ transplantation 4. Any active autoimmune disease or a documented history of autoimmune disease 5. Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus 6. Pregnant or lactating
Интервенции
IMC-001
DRUG
Места на провеждане 5
Южна Корея (5)
Chonnam National University Hwasun Hospital
Gwangju
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Ulsan University Hospital
Ulsan
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
27.10.2020
Крайна дата
28.02.2027
Регистрационен номер
NCT04414163
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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