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재발성 또는 불응성 결절외 NK/T 세포 림프종, 비강 유형 환자에서 IMC-001에 대한 연구

2026년 9월 21일 업데이트: ImmuneOncia Therapeutics Inc.

재발성 또는 불응성 결절외 NK/T 세포 림프종, 비강 유형 환자에서 IMC-001의 효능 및 안전성을 조사하기 위한 공개 라벨, 단일군, 글로벌 2상 연구

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

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

23

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: IMC-001

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

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

다른 이름들:
  • 단버스토툭 (Danburstotug)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Occurrence of Objective Response Rate(ORR)
기간: through study completion, an average of 1 year

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

2차 결과 측정

결과 측정
측정값 설명
기간
Evaluate safety of IMC-001
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

ImmuneOncia Therapeutics Inc.

수사관

  • 수석 연구원: Won Seog Kim, Samsung Medical Center, Republic of Korea

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • 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.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 10월 27일

기본 완료 (실제)

2024년 7월 23일

연구 완료 (추정된)

2027년 2월 28일

연구 등록 날짜

최초 제출

2020년 5월 26일

QC 기준을 충족하는 최초 제출

2020년 5월 29일

처음 게시됨 (실제)

2020년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IMC-001-201

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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