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

Last updated: June 13, 2025
Sponsor: ImmuneOncia Therapeutics Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

T-cell Lymphoma

Lymphoproliferative Disorders

Non-hodgkin's Lymphoma

Treatment

IMC-001

Clinical Study ID

NCT04414163
IMC-001-201
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ENKTL diagnosis;
  • Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasaltype

  • At least 1 previous line of systemic therapy

  • Documented disease progression of last therapy

  1. Adult age(as defined by respective country)

  2. The nature of the study and voluntarily sign an ICF

  3. ECOG 0 or1

  4. Adequate hematologic function, hepatic function, and renal function

Exclusion

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 orhepatitis C virus

  6. Pregnant or lactating

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: IMC-001
Phase: 2
Study Start date:
October 27, 2020
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Chonnam National University Hwasun Hospital

    Hwasun, Chonnam
    Korea, Republic of

    Site Not Available

  • ChungBuk National University Hospital

    Cheonju, Chungbuk
    Korea, Republic of

    Site Not Available

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Site Not Available

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