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评估不良事件、疾病活动变化以及口服 ABBV-101 如何在患有 B 细胞恶性肿瘤的成人参与者体内移动的研究

2026年11月2日 更新者：AbbVie

评估 BTK 降解剂 ABBV-101 在 B 细胞恶性肿瘤参与者中的安全性、药代动力学和初步疗效的首次人体研究

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed.

ABBV-101 is an investigational drug being developed for the treatment of NHL. This study is a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101. Approximately 200 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide.

Participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

135

阶段

  • 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。

学习地点

  • 以色列
    • Central District
      • Tsrifin、Central District、以色列、70300
        • Yitzhak Shamir Medical Center /ID# 254566
    • Jerusalem
      • Jerusalem、Jerusalem、以色列、91120
        • Hadassah Medical Center-Hebrew University /ID# 251123
    • Tel Aviv
      • Ramat Gan、Tel Aviv、以色列、5265601
        • The Chaim Sheba Medical Center /ID# 251122
      • Tel Aviv、Tel Aviv、以色列、6423906
        • Tel Aviv Sourasky Medical Center /ID# 259608
  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2M9
        • University Health Network_Princess Margaret Cancer Centre /ID# 253483
    • Quebec
      • Montreal、Quebec、加拿大、H2X 3E4
        • Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 253428
  • 德国
      • Berlin、德国、12203
        • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 257431
      • Hamburg、德国、20246
        • Universitaetsklinikum Hamburg-Eppendorf /ID# 264566
    • Baden-Wurttemberg
      • Ulm、Baden-Wurttemberg、德国、89081
        • Universitaetsklinikum Ulm /ID# 253742
    • Bavaria
      • Würzburg、Bavaria、德国、97080
        • Universitaetsklinikum Wuerzburg /ID# 254636
    • Mecklenburg-Vorpommern
      • Rostock、Mecklenburg-Vorpommern、德国、18057
        • Universitaetsmedizin Rostock /ID# 259657
    • Saarland
      • Homburg、Saarland、德国、66424
        • Universitaetsklinikum des Saarlandes /ID# 257435
  • 意大利
      • Bergamo、意大利、24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII /ID# 260317
      • Bologna、意大利、40138
        • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255172
    • Milano
      • Milan、Milano、意大利、20132
        • IRCCS Ospedale San Raffaele /ID# 253531
      • Milan、Milano、意大利、20162
        • ASST Grande Ospedale Metropolitano Niguarda /ID# 253532
    • Piedmont
      • Turin、Piedmont、意大利、10126
        • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 253530
  • 日本
    • Chiba
      • Kashiwa-shi、Chiba、日本、277-8577
        • National Cancer Center Hospital East /ID# 250684
    • Kyoto
      • Kyoto、Kyoto、日本、606-8507
        • Kyoto University Hospital /ID# 261837
    • Tokyo
      • Chuo-ku、Tokyo、日本、104-0045
        • National Cancer Center Hospital /ID# 250680
      • Koto-ku、Tokyo、日本、135-8550
        • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 260375
  • 法国
      • Paris、法国、75010
        • Hopital Saint-Louis /ID# 253663
    • Gironde
      • Bordeaux、Gironde、法国、33000
        • Institut Bergonie /ID# 253664
    • Herault
      • Montpellier、Herault、法国、34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 253666
    • Nord
      • Lille、Nord、法国、59037
        • CHRU Lille - Hopital Claude Huriez /ID# 253665
    • Pays de la Loire Region
      • Nantes、Pays de la Loire Region、法国、44000
        • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248
    • Val-de-Marne
      • Villejuif、Val-de-Marne、法国、94805
        • Institut Gustave Roussy /ID# 253662
  • 美国
    • Arizona
      • Tucson、Arizona、美国、85711
        • Arizona Oncology - Tucson - Wilmot Road /ID# 252351
    • California
      • Orange、California、美国、92868-3201
        • UC Irvine Medical Center /ID# 263020
      • Palo Alto、California、美国、94304
        • Stanford University - Palo Alto /ID# 249683
    • Colorado
      • Aurora、Colorado、美国、80012
        • Rocky Mountain Cancer Centers - Aurora /ID# 252237
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern Medicine - Northwestern Memorial Hospital /ID# 249347
    • Massachusetts
      • Boston、Massachusetts、美国、02215-5400
        • Beth Israel Deaconess Medical Center /ID# 249302
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • Rutgers Cancer Institute of New Jersey /ID# 249323
    • New York
      • Albany、New York、美国、12206-5013
        • New York Oncology Hematology - Albany Cancer Center /ID# 252240
      • Lake Success、New York、美国、11042
        • Northwell Health - Monter Cancer Center /ID# 250422
      • Rochester、New York、美国、14642-0001
        • University of Rochester Medical Center /ID# 249324
    • Ohio
      • Cincinnati、Ohio、美国、45267-2827
        • University of Cincinnati /ID# 249299
    • Oregon
      • Eugene、Oregon、美国、97401-6036
        • Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 250341
    • Texas
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center /ID# 249293
  • 英国
    • Cambridgeshire
      • Cambridge、Cambridgeshire、英国、CB2 2QQ
        • Addenbrookes Hospital /ID# 256242
    • England
      • Leicester、England、英国、LE1 5WW
        • Leicester Royal Infirmary /ID# 255171
    • Greater London
      • London、Greater London、英国、SE5 9RS
        • Kings College Hospital NHS Foundation Trust /ID# 253670
      • London、Greater London、英国、NW1 2BU
        • UCLH NHS FT - University College Hospital /ID# 260202
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitario Vall de Hebron /ID# 260447
      • Madrid、西班牙、28034
        • Hospital Universitario Ramon y Cajal /ID# 260450
      • Madrid、西班牙、28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 253654
      • Madrid、西班牙、28050
        • Hospital Universitario HM Sanchinarro /ID# 253655
      • Salamanca、西班牙、37711
        • Hospital Universitario de Salamanca /ID# 253656
    • Madrid
      • Majadahonda、Madrid、西班牙、28222
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260196

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

18年 及以上 (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:

  • For Dose Escalation only (including backfill): Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a documented diagnosis for one of the following third line or later B-cell malignancies, from one of the following world health organization (WHO)-defined histologies (Swerdlow et al 2016):

    • Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

      1. For Dose Escalation backfill only - Bruton's tyrosine kinase inhibitor (BTKi)/Bruton's tyrosine kinase degrader (BTKd)-naïve CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy that cannot be a BTK inhibitor or degrader, and, with the exception of BTK pathway agents, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.
      2. For Dose Escalation backfill only - BTKi/BCL-2i combination regimen-exposed 2L CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received one prior systemic therapy with a BTKi and BCL-2i combination regimen, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.

    • Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell [GCB] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS.

    • Mantle cell lymphoma (MCL)

    • Follicular lymphoma [FL] (grades 1-3b)

    • Marginal zone lymphoma [MZL] (splenic, extranodal, and nodal)

    • Waldenström macroglobulinemia (WM)

    • Transformed indolent non-Hodgkin's lymphoma (iNHL)

  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. For EU only: Participant has an ECOG PS of 0 or 1.

  • Participant has a life expectancy >= 12 weeks.

  • Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed.

  • Adequate hematologic, renal, and hepatic function per the protocol.

Exclusion Criteria:

  • Previously treated with a Bruton's tyrosine kinase (BTK) degrader, except ABBV-101.
  • Known active central nervous system (CNS) disease, or primary CNS lymphoma. Participants with prior CNS disease that have been effectively treated may be eligible.
  • Uncontrolled active systemic infection requiring systemic treatment that is ongoing or was completed <= 14 days before the first dose of study drug, or active cytomegalovirus infection.

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：单组作业
  • 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：Dose Escalation: ABBV-101

Participants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 88 month study duration.
药品：ABBV-101

Oral:Tablet

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
Number of Participants with Adverse Events (AE)
大体时间：Up to Approximately 88 Months

AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to Approximately 88 Months
Change in Laboratory Parameters
大体时间：Up to Approximately 88 Months

Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Up to Approximately 88 Months
Change in Vital Signs
大体时间：Up to Approximately 88 Months

Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Up to Approximately 88 Months
Change in Electrocardiogram (ECG)
大体时间：Up to Approximately 88 Months

12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Up to Approximately 88 Months

次要结果测量

结果测量
措施说明
大体时间
Maximum Observed Serum Concentration (Cmax) of ABBV-101
大体时间：Up to Approximately 88 Months

Maximum observed serum concentration of ABBV-101.
Up to Approximately 88 Months
Time to Cmax (Tmax) of ABBV-101
大体时间：Up to Approximately 88 Months

Time to Cmax of ABBV-101.
Up to Approximately 88 Months
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101
大体时间：Up to Approximately 88 Months

Area under the serum concentration versus time curve (AUC) of ABBV-101.
Up to Approximately 88 Months
Number of Participants with Response of Partial Response (PR) or Better Response (Overall Response) per Disease-Specific Criteria
大体时间：Up to Approximately 88 Months

Number of participants with response of PR or better response (overall response) per disease-specific criteria.
Up to Approximately 88 Months
Duration of Response (DOR)
大体时间：Up to Approximately 88 Months

DOR is defined for participants achieving PR or better as the time from the initial response per Investigator review to disease progression or death of any cause, whichever occurs earlier.
Up to Approximately 88 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

AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

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)

2023年6月9日

初级完成 (估计的)

2031年3月1日

研究完成 (估计的)

2031年3月1日

研究注册日期

首次提交

2023年2月22日

首先提交符合 QC 标准的

2023年2月22日

首次发布 (实际的)

2023年3月3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

关键字

其他相关的 MeSH 术语

其他研究编号

  • M23-647
  • 2023 (美国 NIH 拨款/合同)
  • 2023-503594-38-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

在美国制造并从美国出口的产品

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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