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

IMC-001-201

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

2020-07-28

2024-07-30

2026-02-28

Active (not recruiting)

Early phase I

23

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}

2024-04-12