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JNJ-75276617 在急性白血病参与者中的研究 (cAMeLot-1)

2026年11月2日 更新者：Janssen Research & Development, LLC

Menin-KMT2A (MLL1) 抑制剂 JNJ-75276617 在急性白血病参与者中的首次人体研究

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

420

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100034
        • 招聘中
        • Peking University First Hospital
      • Changchun、中国、130021
        • 招聘中
        • The First Hospital of Jilin University
      • Chengdu、中国、610041
        • 招聘中
        • West China Hospital Si Chuan University
      • Guangzhou、中国、510515
        • 完全的
        • Nanfang Hospital of Southern Medical Hospital
      • Hangzhou、中国、310009
        • 招聘中
        • First Affiliated Hospital Medical School of Zhejiang University
      • Jinan、中国、250012
        • 招聘中
        • Qilu Hospital of Shandong University
      • Nanchang、中国、330006
        • 招聘中
        • The First Affiliated Hospital of NanChang University
      • Nanjing、中国、210009
        • 招聘中
        • Zhongda Hospital Southeast University
      • Tianjin、中国、301609
        • 招聘中
        • Institute of Hematology and Blood Diseases Hospital
      • Wenzhou、中国、325000
        • 招聘中
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan、中国、430022
        • 招聘中
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
      • Zhengzhou、中国、450003
        • 招聘中
        • Henan Cancer Hospital
  • 以色列
      • Haifa、以色列、3436212
        • 招聘中
        • Carmel Medical Center
      • Jerusalem、以色列、9112001
        • 招聘中
        • Hadassah University Hospita Ein Kerem
      • Ramat Gan、以色列、52621
        • 招聘中
        • Sheba Medical Center
      • Tel Aviv、以色列、6423906
        • 招聘中
        • Tel Aviv Sourasky Medical Center
  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • 招聘中
        • Vancouver Coastal Health
    • Ontario
      • Toronto、Ontario、加拿大、M5G 1X6
        • 招聘中
        • Princess Margaret Cancer Centre University Health Network
    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
        • 招聘中
        • Hopital Maisonneuve Rosemont
  • 台湾
      • Taichung、台湾、404327
        • 招聘中
        • China Medical University Hospital
      • Tainan、台湾、704
        • 招聘中
        • National Cheng Kung University Hospital
      • Taipei、台湾、10043
        • 招聘中
        • National Taiwan University Hospital
  • 巴西
      • Brasília、巴西、70390-140
        • 招聘中
        • IDOR - Regional Brasilia
      • Natal、巴西、59062 000
        • 招聘中
        • Liga Norte Riograndense Contra O Cancer
      • Rio de Janeiro、巴西、20230 130
        • 招聘中
        • Ministerio da Saude Instituto Nacional do Cancer
      • São Paulo、巴西、01246 000
        • 招聘中
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • São Paulo、巴西、01509 900
        • 招聘中
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo、巴西、01401 002
        • 招聘中
        • IDOR - Regional Sao Paulo
  • 日本
      • Fukuoka、日本、812-0054
        • 主动，不招人
        • Kyushu University Hospital
      • Fukushima、日本、960 1295
        • 主动，不招人
        • Fukushima Medical University Hospital
      • Kanazawa、日本、920 8641
        • 主动，不招人
        • Kanazawa University Hospital
      • Kashiwa、日本、277-8577
        • 主动，不招人
        • National Cancer Center Hospital East
      • Kobe、日本、650 0047
        • 完全的
        • Kobe City Medical Center General Hospital
      • Maebashi、日本、371-0821
        • 完全的
        • Gunmaken Saiseikai Maebashi Hospital
      • Nagoya、日本、466-8560
        • 完全的
        • Nagoya University Hospital
      • Sapporo、日本、060-8648
        • 完全的
        • Hokkaido University Hospital
      • Tokyo、日本、141-8625
        • 主动，不招人
        • NTT Medical Center Tokyo
      • Yamagata、日本、990 2331
        • 完全的
        • Yamagata University Hospital
      • Yoshida、日本、910-1193
        • 完全的
        • University of Fukui Hospital
  • 比利时
      • Ghent、比利时、9000
        • 招聘中
        • Ghent University Hospital
  • 法国
      • Besançon、法国、25000
        • 招聘中
        • Hopital Jean Minjoz
      • Marseille、法国、13009
        • 招聘中
        • Institut Paoli Calmettes
      • Nantes、法国、44093
        • 招聘中
        • CHU de Nantes hotel Dieu
      • Paris、法国、75010
        • 招聘中
        • Hopital Saint Louis
      • Paris、法国、75012
        • 招聘中
        • Hopital trousseau- APHP
      • Pessac、法国、33604
        • 完全的
        • Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
      • Pierre-Bénite、法国、69310
        • 招聘中
        • CHU Lyon Sud
      • Strasbourg、法国、67098
        • 招聘中
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
      • Toulouse、法国、31059
        • 招聘中
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours、法国、37044
        • 招聘中
        • CHU Bretonneau
      • Vandœuvre-lès-Nancy、法国、54511
        • 招聘中
        • CHRU Nancy Brabois
      • Vandœuvre-lès-Nancy、法国、54500
        • 招聘中
        • CHRU de Nancy - Hopitaux de Brabois
      • Villejuif、法国、94805
        • 招聘中
        • Gustave Roussy
  • 澳大利亚
      • Clayton、澳大利亚、3168
        • 招聘中
        • Monash Medical Centre
      • Perth、澳大利亚、6000
        • 招聘中
        • Royal Perth Hospital
      • Southport、澳大利亚、4211
        • 招聘中
        • Gold Coast University Hospital
  • 美国
    • California
      • Duarte、California、美国、91010
        • 招聘中
        • City of Hope
      • Orange、California、美国、92868
        • 完全的
        • University of California Irvine Medical Center
      • San Francisco、California、美国、94143
        • 招聘中
        • University of California San Francisco
      • San Francisco、California、美国、94158
        • 招聘中
        • UCSF Benioff Children's Hospital
    • Illinois
      • Chicago、Illinois、美国、60637
        • 招聘中
        • University of Chicago
    • Indiana
      • Indianapolis、Indiana、美国、46237
        • 招聘中
        • St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
    • Kentucky
      • Louisville、Kentucky、美国、40207
        • 完全的
        • Norton Cancer Institute
    • Maine
      • South Portland、Maine、美国、04106
        • 招聘中
        • Maine Health
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Massachusetts General Hospital
      • Boston、Massachusetts、美国、02115
        • 招聘中
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit、Michigan、美国、48201 2013
        • 完全的
        • Karmanos Cancer Institute
      • Grand Rapids、Michigan、美国、49546
        • 招聘中
        • Start Midwest
    • New Mexico
      • Albuquerque、New Mexico、美国、87131
        • 招聘中
        • University of New Mexico
    • New York
      • Buffalo、New York、美国、14263
        • 招聘中
        • Roswell Park Comprehensive Cancer Center
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Medical Center
      • The Bronx、New York、美国、10467
        • 招聘中
        • Montefiore Medical Center
    • Oregon
      • Portland、Oregon、美国、97239
        • 招聘中
        • Oregon Health And Science University
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • 完全的
        • Fox Chase Cancer Center
    • Tennessee
      • Knoxville、Tennessee、美国、37920
        • 招聘中
        • University of Tennessee Medical Center
    • Texas
      • Dallas、Texas、美国、75246
        • 招聘中
        • Baylor University Medical Center
      • Houston、Texas、美国、77030
        • 招聘中
        • MD Anderson
      • Houston、Texas、美国、77030-2740
        • 招聘中
        • Houston Methodist Hospital
      • San Antonio、Texas、美国、78229
        • 招聘中
        • San Antonio Methodist TX Transplant Physicians Group
    • Virginia
      • Richmond、Virginia、美国、23298
        • 招聘中
        • Virginia Commonwealth University
    • Washington
      • Seattle、Washington、美国、98104
        • 招聘中
        • Swedish Cancer Institute
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • 招聘中
        • Medical College of WI at Froedtert
  • 英国
      • Cardiff、英国、CF14 4XW
        • 招聘中
        • University Hospital of Wales
      • Leeds、英国、LS9 7TF
        • 招聘中
        • Leeds Teaching Hospitals NHS Trust
      • Liverpool、英国、L7 8YA
        • 招聘中
        • The Clatterbridge Cancer Centre
      • London、英国、SE1 9RT
        • 招聘中
        • Guys and St Thomas NHS Foundation Trust
      • London、英国、W1T 7HA
        • 招聘中
        • University College London Hospitals
      • Manchester、英国、M20 4BX
        • 招聘中
        • The Christie Nhs Foundation Trust
      • Oxfordshire、英国、OX3 7LE
        • 招聘中
        • Oxford University Hospitals NHS Trust
      • Plymouth、英国、PL6 8DH
        • 招聘中
        • University Hospitals Plymouth NHS Trust
  • 西班牙
      • Barcelona、西班牙、08036
        • 招聘中
        • Hosp Clinic de Barcelona
      • Barcelona、西班牙、08035
        • 招聘中
        • Hosp Univ Vall D Hebron
      • Madrid、西班牙、28009
        • 招聘中
        • Hospital Infantil Universitario Nino Jesus
      • Madrid、西班牙、28007
        • 招聘中
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid、西班牙、28040
        • 招聘中
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona、西班牙、31008
        • 招聘中
        • Clinica Univ. de Navarra
      • Salamanca、西班牙、37007
        • 招聘中
        • Hosp Clinico Univ de Salamanca
      • Seville、西班牙、41013
        • 招聘中
        • Hosp. Virgen Del Rocio
      • Valencia、西班牙、46010
        • 招聘中
        • Hosp. Clinico Univ. de Valencia
  • 韩国
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
      • Seoul、韩国、03080
        • 招聘中
        • Seoul National University Hospital
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Phase 1:

  • Age 2 years to less than (<) 18 years of age (pediatric cohort only), all other cohorts 18 years and above
  • Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
  • Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations

Phase: 2

  • Participants greater than 18 years are eligible
  • Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
  • AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only

For Both Phase 1 and 2:

  • Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count <= 20*10^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate >= 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate >=40 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status >=70 by Lansky scale (for participants < 16 years of age) or >=70 Karnofsky scale (for participants >=16 years of age)
  • A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
  • Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment

Exclusion Criteria:

  • Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
  • Active central nervous system (CNS) disease
  • Prior solid organ transplantation
  • QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
  • Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment ; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
  • Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Bleximenib

Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1. In Phase 2 participants will receive bleximenib at the RP2D to evaluate anti-leukemia activity and demonstrate acceptable safety at the RP2D(s).
药品：Bleximenib

Bleximenib is administered orally.

其他名称：
  • JNJ-75276617

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
大体时间：Up to 4 years and 9 months

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 4 years and 9 months
Phase 1: Number of Participants with AEs by Severity
大体时间：Up to 4 years and 9 months

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to 4 years and 9 months
Phase 1: Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT)
大体时间：Up to 28 days Cycle 1

Percentage of participants with DLT will be assessed accordingly to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.
Up to 28 days Cycle 1
Phase 2: Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh)
大体时间：Up to 4 years and 9 months

Rate of CR/CRh is defined as the percentage of participants achieving a CR or CRh at any time post-treatment.
Up to 4 years and 9 months

次要结果测量

结果测量
措施说明
大体时间
Phase 1 and 2: Plasma Concentration of Bleximenib
大体时间：Up to 4 years and 9 months

Plasma concentration of bleximenib will be reported.
Up to 4 years and 9 months
Phase 1 and 2: Overall Response Rate (ORR)
大体时间：Up to 4 years and 9 months

ORR is defined as the percentage of participants who achieve any response.
Up to 4 years and 9 months
Phase 1: Duration of Response (DOR)
大体时间：Up to 4 years and 9 months

DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first.
Up to 4 years and 9 months
Phase 1 and 2: Time To Response (TTR)
大体时间：Up to 4 years and 9 months

TTR is defined for the responders as the time from the date of the first dose of bleximenib to the date of the first documented response.
Up to 4 years and 9 months
Phase 2: Duration of Complete Response (CR)/Complete Remission With Partial Hematologic Recovery (CRh)
大体时间：Up to 4 years and 9 months

The duration of CR/CRh is defined from the date of first CR or CRh response achieved to the date of first evidence of relapsed disease or death due to any cause, whichever occurs first, for participants who achieve a CR or CRh.
Up to 4 years and 9 months
Phase 2: Time To CR/CRh
大体时间：Up to 4 years and 9 months

Time to CR/CRh is defined for responders as the time from the date of the first dose of bleximenib to the date of first achieving either CR or CRh, depending on which milestone is reached.
Up to 4 years and 9 months
Phase 2: Event-free survival (EFS)
大体时间：Up to 4 years and 9 months

EFS is defined as the time from the date of first dose of study treatment to the date of treatment failure, relapse, or death due to any cause, whichever occurs first.
Up to 4 years and 9 months
Phase 2: Overall survival (OS)
大体时间：Up to 4 years and 9 months

OS is defined from the date of first dose of study treatment to the date of death due to any cause.
Up to 4 years and 9 months
Phase 2: Measurable Residual Disease (MRD) Negativity Among Participants Achieving CR/CRh/CRi
大体时间：Up to 4 years and 9 months

MRD-negative rate is defined as the percentage of participants who are MRD-negative at any timepoint after the first dose of bleximenib in the responders.
Up to 4 years and 9 months
Phase 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Up to 4 years and 9 months

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A Serious AE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to 4 years and 9 months
Phase 2: Number of Participants Reporting Transfusion Independence
大体时间：Up to 4 years and 9 months

Transfusion independence is defined as independence from red blood cells (RBC) and platelet transfusions during any 56-day interval after receiving study treatment.
Up to 4 years and 9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

调查人员

  • 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月19日

初级完成 (估计的)

2028年12月29日

研究完成 (估计的)

2030年9月22日

研究注册日期

首次提交

2021年3月22日

首先提交符合 QC 标准的

2021年3月22日

首次发布 (实际的)

2021年3月23日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CR108998
  • 75276617ALE1001 (其他标识符：Janssen Research & Development, LLC)
  • 2023-506581-31-00 (注册表标识符：EUCT number)
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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