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

Primary Purpose

Extranodal NK/T-cell Lymphoma, Nasal Type, Extranodal NK/T-cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IMC-001
Sponsored by
ImmuneOncia Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type focused on measuring IMC-001, IMC-001-201, DISTINKT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun HospitalRecruiting
  • ChungBuk National University HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Ulsan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMC-001

Arm Description

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

Outcomes

Primary Outcome Measures

Occurrence of Objective Response Rate(ORR)
Lugano criteria with LYRIC modification

Secondary Outcome Measures

Full Information

First Posted
May 26, 2020
Last Updated
March 24, 2023
Sponsor
ImmuneOncia Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04414163
Brief Title
A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmuneOncia Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T-cell Lymphoma, Nasal Type, Extranodal NK/T-cell Lymphoma
Keywords
IMC-001, IMC-001-201, DISTINKT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMC-001
Arm Type
Experimental
Arm Description
Single Dose level (IMC-001 20mg/kg, every 2 weeks)
Intervention Type
Drug
Intervention Name(s)
IMC-001
Other Intervention Name(s)
Not confirm yet
Intervention Description
Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)
Primary Outcome Measure Information:
Title
Occurrence of Objective Response Rate(ORR)
Description
Lugano criteria with LYRIC modification
Time Frame
1 year (Not confirmed yet)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JiEun Oh
Phone
+82 31 707 8133
Email
IOCSO@immuneoncia.com
First Name & Middle Initial & Last Name or Official Title & Degree
MinYoung Son
Phone
+82 31 707 8133
Email
IOCSO@immuneoncia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JiEun Oh
Organizational Affiliation
ImmuneOncia Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Chonnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deok-Hwan Yang
Facility Name
ChungBuk National University Hospital
City
Cheonju
State/Province
Chungbuk
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihyun Kwon
Facility Name
Gyeongsang National University Hospital
City
Jinju
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyeong-Won Lee
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwai Han Yoo
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dok Hyun Yoon
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junshik Hong
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Cheol Jo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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