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Uno studio sull'IMC-001 in soggetti con linfoma extranodale a cellule NK/T recidivato o refrattario, tipo nasale

21 settembre 2026 aggiornato da: ImmuneOncia Therapeutics Inc.

Uno studio globale di fase 2 in aperto, a braccio singolo, per studiare l'efficacia e la sicurezza di IMC-001 in pazienti con linfoma extranodale a cellule NK/T recidivato o refrattario, tipo nasale

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

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

23

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea del Sud
      • Gwangju, Corea del Sud
        • Chonnam National University Hwasun Hospital
      • Seoul, Corea del Sud
        • Asan Medical Center
      • Seoul, Corea del Sud
        • Samsung Medical Center
      • Seoul, Corea del Sud
        • Seoul National University Hospital
      • Ulsan, Corea del Sud
        • Ulsan University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: IMC-001

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

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

Altri nomi:
  • Danburstotug

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Occurrence of Objective Response Rate(ORR)
Lasso di tempo: through study completion, an average of 1 year

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluate safety of IMC-001
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ImmuneOncia Therapeutics Inc.

Investigatori

  • Investigatore principale: Won Seog Kim, Samsung Medical Center, Republic of Korea

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 ottobre 2020

Completamento primario (Effettivo)

23 luglio 2024

Completamento dello studio (Stimato)

28 febbraio 2027

Date di iscrizione allo studio

Primo inviato

26 maggio 2020

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2020

Primo Inserito (Effettivo)

4 giugno 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IMC-001-201

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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