Status:
ACTIVE_NOT_RECRUITING
A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
Lead Sponsor:
ImmuneOncia Therapeutics Inc.
Conditions:
Extranodal NK/T-cell Lymphoma, Nasal Type
Extranodal NK/T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- Adult age(as defined by respective country)
- The nature of the study and voluntarily sign an ICF
- ECOG 0 or1
- Adequate hematologic function, hepatic function, and renal function
Exclusion
- Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- Known presence of symptomatic CNS metastases
- Prior allogeneic HSCT or solid organ transplantation
- Any active autoimmune disease or a documented history of autoimmune disease
- Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus
- Pregnant or lactating
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2026
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04414163
Start Date
October 27 2020
End Date
February 28 2026
Last Update
June 18 2025
Active Locations (5)
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1
Chonnam National University Hwasun Hospital
Gwangju, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Samsung Medical Center
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea