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