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En undersøgelse af IMC-001 i forsøgspersoner med recidiverende eller refraktær ekstranodal NK/T-cellelymfom, næsetype

21. september 2026 opdateret af: ImmuneOncia Therapeutics Inc.

Et åbent, enkeltarmet, globalt fase 2-studie for at undersøge effektiviteten og sikkerheden af ​​IMC-001 hos patienter med recidiverende eller refraktær ekstranodal NK/T-cellelymfom, nasal type

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

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
      • Gwangju, Sydkorea
        • Chonnam National University Hwasun Hospital
      • Seoul, Sydkorea
        • Asan Medical Center
      • Seoul, Sydkorea
        • Samsung Medical Center
      • Seoul, Sydkorea
        • Seoul National University Hospital
      • Ulsan, Sydkorea
        • Ulsan University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IMC-001

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

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

Andre navne:
  • Danburstotug

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of Objective Response Rate(ORR)
Tidsramme: through study completion, an average of 1 year

Lugano criteria with LYRIC modification
through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate safety of IMC-001
Tidsramme: through study completion, an average of 1 year

Terms, frequency, severity and seriousness of AEs and relationship of AEs to IMC-001
through study completion, an average of 1 year
Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate
Tidsramme: 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.

Complete Response (CR) rate, (Unit of Measure: Percentage of participants)

  1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
  2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
  3. based on response as determined by the investigator per the Lugano criteria
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)
Tidsramme: 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.

Disease Control Rate (DCR), (Unit of Measure: Percentage of participants)

  1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
  2. based on response as determined by the investigator per the Lugano criteria
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)
Tidsramme: 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.

Progression-Free Survival (PFS), (Unit of Measure: Months)

  1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
  2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
  3. based on response as determined by the investigator per the Lugano criteria
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)
Tidsramme: 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.

Duration of Response (DOR), (Unit of Measure: Months)

  1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
  2. based on response as determined by the investigator per the Lugano criteria
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 : Time to Progression (TTP)
Tidsramme: 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.

Time to Progression (TTP), (Unit of Measure: Months)

  1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
  2. based on response as determined by the investigator per the Lugano criteria
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 : Overall Response Rate (ORR)
Tidsramme: 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.

Overall Response Rate (ORR), (Unit of Measure: Percentage of participants)

  1. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
  2. based on response as determined by the investigator per the Lugano criteria
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 : Overall Survival (OS)
Tidsramme: through study completion, an average of 1 year

Overall Survival (OS), (Unit of Measure: Months)
through study completion, an average of 1 year
Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough
Tidsramme: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)

The trough level or trough concentration (Ctrough) of IMC-001 measured at specified time points.
Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)
Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax
Tidsramme: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)

The maximum observed serum concentration (Cmax) of IMC-001 observed during dosing interval.
Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)
Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA)
Tidsramme: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)

Incidence of anti-drug antibody (ADA) (including serum titers of anti-IMC-001 antibodies) The percentage of patients demonstrating anti-IMC-001 antibodies will be calculated.
Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)
Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity
Tidsramme: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)

Correlation Between ADA and Drug Exposure and Activity The Spearman nonparametric correlation coefficient will be calculated to quantify the relationship between titer of anti-IMC-001 antibodies and exposure and activity.
Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ImmuneOncia Therapeutics Inc.

Efterforskere

  • Ledende efterforsker: Won Seog Kim, Samsung Medical Center, Republic of Korea

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. oktober 2020

Primær færdiggørelse (Faktiske)

23. juli 2024

Studieafslutning (Anslået)

28. februar 2027

Datoer for studieregistrering

Først indsendt

26. maj 2020

Først indsendt, der opfyldte QC-kriterier

29. maj 2020

Først opslået (Faktiske)

4. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMC-001-201

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