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

An Open-label, Single-arm, Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

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

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.

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