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Active (not recruiting) Phase 2 NCT04414163

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

Phase 2 – studying effectiveness and dosage
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type Extranodal NK/T-cell Lymphoma

Sponsor: ImmuneOncia Therapeutics Inc.

trial.available_in: БГ
Overview
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
Description
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.
Who can participate
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
Interventions
IMC-001
DRUG
Locations 5
South Korea (5)
Chonnam National University Hwasun Hospital
Gwangju
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Ulsan University Hospital
Ulsan
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
27.10.2020
Completion date
28.02.2027
Registry ID
NCT04414163
Source
clinicaltrials.gov
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