NCT04414163

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
10mo left

Started Oct 2020

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Oct 2020Feb 2027

First Submitted

Initial submission to the registry

May 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2024

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Expected
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

May 26, 2020

Last Update Submit

April 21, 2026

Conditions

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

Keywords

IMC-001IMC-001-201DISTINKT

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Objective Response Rate(ORR)

    Lugano criteria with LYRIC modification

    through study completion, an average of 1 year

Secondary Outcomes (12)

  • Evaluate safety of IMC-001

    through study completion, an average of 1 year

  • Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate

    The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

  • Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)

    The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

  • Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)

    The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

  • Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)

    The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.

  • +7 more secondary outcomes

Study Arms (1)

IMC-001

EXPERIMENTAL

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

Drug: IMC-001

Interventions

IMC-001DRUG

Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)

Also known as: Danburstotug
IMC-001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chonnam National University Hwasun Hospital

Gwangju, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (8)

  • W.S.Kim, et al. AI-Based Membrane Specific PD-L1 and Tumor Immune Microenvironment as Predictive Biomarkers for Danburstotug in Relapsed or Refractory Extranodal NK/T cell Lymphoma (R/R ENKTL): Insights from A Phase II Trial (DISTINKT). ICKSH; 2026; Seoul, Korea; AK-0083.

    BACKGROUND

  • W.S.Kim, et al. AI-based membrane specific PD-L1 and tumor immune microenvironment (TIME) subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). T-cell lymphoma forum; 2026; San Diego, California, USA; TCLF38.

    BACKGROUND

  • W.S.Kim, et al. Artificial intelligence (AI)-based membrane specific PD-L1 and immune subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). ASH; 2025; Orlando, USA; 5426.

    BACKGROUND

  • T.W.Sung, et al. Optimizing IMC-001 Dosage Regimens Using Target Mediated Drug Disposition Model: Enhancing Therapeutic Efficacy and Safety in Cancer Treatment. PAGE; 2024; Rome, Italy; Abstract 10927.

    BACKGROUND

  • W.S.Kim, et al. ENHANCED EFFICACY AND SAFETY FROM PHASE 2 STUDY OF IMC-001, ANTI-PD-L1 ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY EXTRANODAL NK/T CELL LYMPHOMA (R/R ENKTL), NASAL TYPE: DISTINKT STUDY. EHA; 2024; Madrid, Spain; P1213.

    BACKGROUND

  • J.H.Jeon, et al. Exposure-response (E-R) relationship between PD-L1 recombinant monoclonal antibody IMC-001 in relapsed or refractory extranodal NK/T cell lymphoma nasal type patients. ACoP; 2024; Phoenix, Arizona, USA; T-058.

    BACKGROUND

  • W.S.Kim, et al. Phase 2 study to investigate the efficacy and safety of IMC-001, anti-PD-L1 antibody, in Patients with relapsed or refractory extranodal NK/T Cell lymphoma, nasal Type: DISTINKT Study. ICML; 2023; Lugano, Switzerland; Abstract 433.

    BACKGROUND

  • W.S.Kim, et al. Efficacy and Safety of IMC-001, anti-PD-L1 antibody, in Patients with Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type (R/R ENKTL). ESMO; 2022; Singapore, Republic of Singapore; Abstract 494.

    BACKGROUND

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

IMC-001

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Won Seog Kim

    Samsung Medical Center, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 4, 2020

Study Start

October 27, 2020

Primary Completion

July 23, 2024

Study Completion (Estimated)

February 28, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(5)