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GEN3013, 재발성, 진행성 또는 불응성 B세포 림프종 EPCORE™ NHL-1 환자를 대상으로 한 엡코리타맙 임상시험 (EPCORE™ NHL-1)

2026년 11월 2일 업데이트: Genmab

재발성, 진행성 또는 불응성 B세포 림프종 EPCORE™NHL-1 환자를 대상으로 한 GEN3013의 1/2상, 공개 라벨 안전성 시험

The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):

  • The dose schedule for epcoritamab
  • The side effects seen with epcoritamab
  • What the body does with epcoritamab once it is administered
  • What epcoritamab does to the body once it is administered
  • How well epcoritamab works against relapsed and/or refractory B-cell lymphoma

The trial consists of 3 parts:

  • a dose-escalation part (Phase 1, first-in-human [FIH])
  • an expansion part (Phase 2a)
  • a dose-optimization part (OPT) (Phase 2a)

The trial time for each participant depends on which trial part the participant enters:

  • For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
  • For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).

Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.

All participants will receive active drug, and no participants will be given placebo.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as to establish the safety profile of epcoritamab in participants with relapsed or refractory B-cell lymphoma.

In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

The dose-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma (MCL)

All participants will receive epcoritamab at the RP2D.

연구 유형

중재적

등록 (실제)

666

단계

  • 2 단계
  • 1단계

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연락처 및 위치

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

연구 장소

  • 네덜란드
      • Amsterdam, 네덜란드
        • VU University Medical Center
      • Maastricht, 네덜란드, 6229 HX
        • Maastricht University Medical Center
      • Rotterdam, 네덜란드
        • Erasmus MC Cancer Institute
      • Utrecht, 네덜란드
        • Universitair Medisch Centrum Utrecht
  • 대한민국
      • Busan, 대한민국
        • Dong-A University Hospital
      • Daegu, 대한민국
        • Keimyung University Dongsan Medical Center
      • Goyang-si, 대한민국
        • National Cancer Center
      • Jeonju, 대한민국
        • Chonbuk National University Hospital
      • Seongnam-si, 대한민국
        • Seoul National University Bundang Hospital
      • Seoul, 대한민국
        • Asan Medical Center
      • Seoul, 대한민국
        • Samsung Medical Center
      • Seoul, 대한민국
        • Seoul National University Hospital
      • Seoul, 대한민국
        • Severance Hospital, Yonsei University
  • 덴마크
      • Copenhagen, 덴마크
        • Rigshospitalet
      • Odense, 덴마크, 5000 C
        • Odense University Hospital
      • Vejle, 덴마크
        • Vejle Hospital
  • 독일
      • Berlin, 독일
        • Charite - Universitaetsmedizin Berlin
      • Berlin, 독일
        • Klinik fur Innere Medizin Hamatologie and Onkologie
      • Cologne, 독일
        • Universitaetsklinikum Koeln
      • Essen, 독일
        • Universitaetsklinikum Essen
      • Mainz, 독일
        • Johannes Gutenberg University
      • München, 독일
        • Der Universität Munchen Medizinische Klinik III LMU
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85054
        • Arizona Mayo Clinic
    • California
      • San Francisco, California, 미국, 94117
        • University of California at San Francisco
    • Colorado
      • Denver, Colorado, 미국, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • Tampa, Florida, 미국, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Iowa
      • Iowa City, Iowa, 미국, 52242
        • University of Iowa Hospital and Clinics
    • Louisiana
      • New Orleans, Louisiana, 미국, 70121
        • Ochsner Medical Center
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan
      • Detroit, Michigan, 미국, 48334
        • Barbara Ann Karmanos Cancer Institute
    • Nebraska
      • Omaha, Nebraska, 미국, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • Hackensack Meridian Health
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • The Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, 미국, 97210
        • OHSU Knight Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15232
        • Hillman Cancer Center
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, 미국, 75390
        • UT Southwestern
      • Houston, Texas, 미국, 77030
        • MD Anderson Cancer Center
  • 스웨덴
      • Lund, 스웨덴
        • Skåne University Hospital
      • Stockholm, 스웨덴
        • Karolinska University Hospital Huddinge
      • Uppsala, 스웨덴
        • Akademiska sjukhuset Uppsala University Hospital
  • 스페인
      • Badalona, 스페인
        • Hospital Germans Trias i Pujol
      • Barcelona, 스페인
        • Institut Catala de Oncologia
      • Barcelona, 스페인
        • Hospital Universitario Vall dHebron
      • Madrid, 스페인
        • Hospital Universitario Fundacin Jimnez Daz
    • Navarre
      • Pamplona, Navarre, 스페인, 31008
        • Clinica Universidad de Navarra
  • 싱가포르
      • Singapore, 싱가포르
        • National University Hospital
      • Singapore, 싱가포르
        • Singapore General Hospital
  • 영국
      • Manchester, 영국
        • The Christie NHS Foundation Trust
      • Plymouth, 영국
        • Plymouth University School of Medicine- Derriford Hospital
      • Southampton, 영국
        • University Hospital Southampton NHS Foundation Trust
      • Sutton, 영국
        • Royal Marsden NHS Foundation Trust
  • 이탈리아
      • Alessandria, 이탈리아
        • Ao Ss Antonio E Biagio Alessandria
      • Bologna, 이탈리아
        • Policlinico S. Orsola-Ematologia LA Seragnoli
      • Candiolo, 이탈리아
        • Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia
      • Meldola, 이탈리아
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, 이탈리아
        • IRCCS Ospedale San Raffaele
  • 캐나다
      • Calgary, 캐나다
        • Tom Baker Cancer Care
      • Toronto, 캐나다
        • Toronto-Sunnybrook Regional Cancer Ctr
  • 폴란드
      • Bydgoszcz, 폴란드
        • Szpital Uniwersytecki nr 2 im dr. Jana Biziela
      • Gdansk, 폴란드
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, 폴란드
        • Pratia-McM
      • Słupsk, 폴란드
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
      • Warsaw, 폴란드
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute
      • Wroclaw, 폴란드
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • 프랑스
      • Créteil, 프랑스
        • Hopital Henri Mondor
      • Montpellier, 프랑스
        • CHU Montpellier
      • Paris, 프랑스
        • Hospital Saint-Louis
      • Pierre-Bénite, 프랑스
        • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
      • Rouen, 프랑스
        • Centre Henri Becquerel
      • Tours, 프랑스
        • CHU de Tours-Hopital Bretonneau
  • 핀란드
      • Helsinki, 핀란드
        • Helsinki University Hospital
      • Kuopio, 핀란드
        • Kuopio University Hospital
      • Tampere, 핀란드
        • Tampere University Hospital
  • 호주
      • Clayton, 호주
        • Monash Health
      • Concord, 호주
        • Concord Hospital
      • Fitzroy, 호주
        • St. Vincent Hospital
      • Herston, 호주
        • Royal Brisbane and Women's Hospital
      • Hobart, 호주
        • Royal Hobart Hospital RHH
      • Kogarah, 호주
        • St. George Hospital
      • Malvern, 호주
        • Cabrini Hospital
      • Nedlands, 호주
        • Sir Charles Gairdner Hospital
      • Southport, 호주
        • Gold Coast Hospital
      • Sydney, 호주
        • Westmead 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

Main Inclusion Criteria - Escalation Part (recruitment completed)

  • Documented CD20+ mature B-cell neoplasm

    1. DLBCL - de novo or transformed
    2. HGBCL
    3. PMBCL
    4. FL
    5. MCL
    6. SLL
    7. MZL (nodal, extranodal or mucosa associated)

  • Relapsed and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.

  • Participants must have measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or Positron emission tomography-Computed tomography (PET-CT) scan

  • Acceptable renal function.

  • Acceptable liver function.

Main Inclusion Criteria - Expansion & Dose-OPT Parts

  • Documented CD20 positive mature B cell neoplasm or CD20+ MCL.
  • DLBCL, de novo or transformed (including double hit or triple hit).
  • PMBCL
  • FL grade 3B
  • Histologic confirmed FL
  • MZL
  • SLL
  • MCL (prior Bruton's tyrosine kinase inhibitor [BTKi] or intolerant to BTKi)
  • At least 2 therapies including an anti-CD20 monoclonal antibody containing chemotherapy combination regimen.
  • Either failed prior autologous hematopoietic stem cell transplantation (HSCT) or ineligible for autologous stem cell transplantation due to age or comorbidities.
  • At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes.

Main Exclusion Criteria - All Parts

  • Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
  • Known past or current malignancy other than inclusion diagnosis.
  • Aspartate aminotransferase (AST), and/or alanine transaminase (ALT) >3 × upper limit of normal.
  • Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
  • Estimated Creatinine clearance (CrCl) <45 milliliters (mL)/min.
  • Known clinically significant cardiovascular disease.
  • Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past coronavirus disease 2019 (COVID-19) infection may be a risk factor.
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics).
  • Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20.
  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration.
  • Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue.
  • Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation.
  • Active hepatitis B (deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]-positive) or hepatitis C (ribonucleic acid [RNA] PCR-positive infection). Participants with evidence of prior hepatitis B (HBV) but who are PCR-negative are permitted in
  • Known human immunodeficiency virus (HIV) infection.
  • Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed consent form (ICF).
  • Pregnancy or breast feeding.
  • Participant is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the participant.
  • Contraindication to all uric acid lowering agents.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Epcoritamab

Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
생물학적: Epcoritamab

Administered as specified in the treatment arm.

다른 이름들:
  • GEN3013
  • 듀오바디®-CD3xCD20
  • 에프킨리™

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Dose-Escalation: Dose Limiting Toxicity (DLT)
기간: During the first cycle (28 days)

To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
During the first cycle (28 days)
Dose-Escalation: Number of Participants with Adverse Events (AEs)
기간: From first dose until the end of the safety follow-up period (Up to 1 year)

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
From first dose until the end of the safety follow-up period (Up to 1 year)
Expansion: Overall Response Rate (ORR)
기간: Up to 1.5 years

ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
Up to 1.5 years
Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
기간: From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)

CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)

2차 결과 측정

결과 측정
측정값 설명
기간
용량 에스컬레이션 및 복용량 -OPT DLBCL, FL 및 MCL : Epcoritamab의 사전 복용량 값
기간: 각 사이클의 여러 시계 (사이클 길이 = 28 일)에서 사전 로스 및 우편 발사, 최대 약 1.5 년
각 사이클의 여러 시계 (사이클 길이 = 28 일)에서 사전 로스 및 우편 발사, 최대 약 1.5 년
모든 부분 : 혈장에서 Epcoritamab의 전체 신체 제거 (CL)
기간: 각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
모든 부품 : Epcoritamab의 곡선 아래 (AUC)
기간: 각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
모든 부분 : Epcoritamab의 최대 (피크) 혈장 농도 (CMAX)
기간: 각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
모든 부분 : Epcoritamab의 Cmax에 도달 할 시간
기간: 각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
모든 부분 : Epcoritamab의 반 수명 (T1/2)
기간: 각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
각 사이클의 다중 시계 (사이클 길이 = 28 일)에서 미리 및 사후 복용, 용량-대분은 1 년까지; 확장 및 복용량 -OPT 부분 : 최대 1.5 년
팽창 : Epcoritamab의 최저 농도
기간: 최대 1.5 년
최대 1.5 년
Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
기간: Up to 1 year

Anti-lymphoma activity will be evaluated as number of participants with resolution of constitutional symptoms, reduction in tumor size, objective, and best response (ORR, CR and PR).
Up to 1 year
Dose-Escalation: Duration of Response (DOR)
기간: Up to 1 year

DOR is defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurs earlier as assessed by the investigator.
Up to 1 year
Expansion: DOR
기간: Up to 1.5 years

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria.
Up to 1.5 years
Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
기간: Up to 1.5 year

Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.
Up to 1.5 year
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
기간: Up to 1.5 years

CRS will be graded based on ASTCT criteria.
Up to 1.5 years
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
기간: Up to 1.5 years

CRS will be graded based on ASTCT criteria.
Up to 1.5 years
Dose-OPT DLBCL and FL: ORR
기간: Up to 1.5 years

ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: CR Rate
기간: Up to 1.5 years

CR rate is defined as the percentage of participants with CR assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: Duration of CR (DoCR)
기간: Up to 1.5 years

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
기간: Up to 1.5 years

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: DLT
기간: During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)

To determine the MTD and/or RP2D to be studied in the expansion part. DLT will be graded according to NCI-CTCAE version 5.0.
During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
Dose-OPT DLBCL, FL and MCL: DOR
기간: Up to 1.5 years

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by investigator.
Up to 1.5 years
Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS
기간: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on Lugano criteria.
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years
Expansion and Dose-OPT MCL: CR Rate
기간: Up to 1.5 years

CR rate is defined as the percentage of participants with CR based on Lugano criteria.
Up to 1.5 years
Expansion and Dose-OPT MCL: DoCR
기간: Up to 1.5 years

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on Lugano criteria.
Up to 1.5 years
Expansion and Dose-OPT MCL: ORR
기간: Up to 1.5 years

ORR is defined as the percentage of participants achieving CR or PR based on LYRIC.
Up to 1.5 years
Expansion: Time to Response (TTR)
기간: Up to 1.5 years

TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on Lugano criteria.
Up to 1.5 years
Expansion and Dose-OPT MCL: CR Rate
기간: Up to 1.5 years

CR rate is defined as the percentage of participants with CR based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT MCL: PFS
기간: Up to 1.5 years

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT MCL: DOR
기간: Up to 1.5 years

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT MCL: DoCR
기간: Up to 1.5 years

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT: TTR
기간: Up to 1.5 years

TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs
기간: Up to 7 years and 6 months

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Up to 7 years and 6 months
Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity
기간: Up to 1.5 years

MRD is defined as percentage of participants with at least 1 MRD negative result.
Up to 1.5 years
All Parts: Number of Participants with CRS Events
기간: Up to Day 1 of Cycle 12 (Cycle length=28 days)

CRS will be graded based on ASTCT criteria.
Up to Day 1 of Cycle 12 (Cycle length=28 days)
All Parts: Number of Participants with Anti-drug Antibody (ADA)
기간: Up to 7 years and 6 months

Plasma samples will be screened for antibodies binding to epcoritamab, and for confirmed positive samples, the titer against the two specific arms of epcoritamab will be reported.
Up to 7 years and 6 months
All Parts: Time to Next Anti-lymphoma Therapy (TTNT)
기간: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years

TTNT is defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years
All Parts: Overall survival (OS)
기간: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years

OS is defined as the time from Day 1 of Cycle 1 to death.
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Genmab

협력자

AbbVie

수사관

  • 연구 책임자: Study Official, Genmab

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

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)

2018년 6월 26일

기본 완료 (추정된)

2029년 1월 1일

연구 완료 (추정된)

2029년 1월 1일

연구 등록 날짜

최초 제출

2018년 6월 7일

QC 기준을 충족하는 최초 제출

2018년 8월 9일

처음 게시됨 (실제)

2018년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GCT3013-01
  • 2017-001748-36 (EudraCT 번호)
  • 2017 (미국 NIH 보조금/계약)
  • NL64317.078.17 (레지스트리 식별자: CCMO)
  • 241053 (기타 식별자: IRAS ID; UK Research Summaries Database)
  • 2023 (미국 NIH 보조금/계약)
  • 2023-504802-12-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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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