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

Sponsor
ImmuneOncia Therapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04414163
Collaborator
(none)
20
Enrollment
3
Locations
1
Arm
71.1
Anticipated Duration (Months)
6.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Single-arm, Global 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
Actual Study Start Date :
Jul 28, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: IMC-001

Single Dose level (IMC-001 20mg/kg, every 2 weeks)

Drug: IMC-001
Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)
Other Names:
  • Not confirm yet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of Objective Response Rate(ORR) [1 year (Not confirmed yet)]

      Lugano criteria with LYRIC modification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonnam National University Hwasun Hospital Hwasun Chonnam Korea, Republic of
    2 Asan Medical Center Seoul Korea, Republic of
    3 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • ImmuneOncia Therapeutics Inc.

    Investigators

    • Study Director: Ji Hye Lee, ImmuneOncia Therapeutics Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ImmuneOncia Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT04414163
    Other Study ID Numbers:
    • IMC-001-201
    First Posted:
    Jun 4, 2020
    Last Update Posted:
    Oct 27, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ImmuneOncia Therapeutics Inc.
    IMC-001
    IMC-001-201
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Lymphoma, Extranodal NK-T-Cell

    Study Results

    No Results Posted as of Oct 27, 2020