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一项针对先前接受过 Ciltacabtagene Autoleucel 治疗的参与者的长期研究

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

对先前接受过 Ciltacabtagene Autoleucel 治疗的参与者的长期随访研究

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Cilta-cel (JNJ-68284528/LCAR-B38M chimeric antigen receptor T-cells [CAR-T]) is an autologous CAR-T therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. There will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. The study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and Year 6 to 15 years after last dose of cilta-cel. Safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). The duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.

研究类型

介入性

注册 (估计的)

295

阶段

  • 第四阶段

扩展访问

可用的 查看扩展访问记录。

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、100191
        • 主动，不招人
        • Peking University Third Hospital
      • Chengdu、中国、610041
        • 主动，不招人
        • West China Hospital Si Chuan University
      • Fuzhou、中国、350000
        • 主动，不招人
        • Fujian Medical University Union Hospital
      • Guangzhou、中国、510060
        • 主动，不招人
        • Sun Yat-sen University Cancer Hospital
      • Hangzhou、中国、310003
        • 主动，不招人
        • First Hospital, Zhejiang University Medical College
      • Nanjing、中国、210008
        • 主动，不招人
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
      • Nanjing、中国、210029
        • 主动，不招人
        • Jiangsu Province Hospital
      • Shanghai、中国、200003
        • 主动，不招人
        • Shanghai Changzheng Hospital
      • Shanghai、中国、200434
        • 主动，不招人
        • Shanghai Fourth People s Hospital
      • Shanghai、中国、200025
        • 主动，不招人
        • Ruijin Hospital Shanghai Jiao Tong University
      • Xi'an、中国、710004
        • 主动，不招人
        • The Second Affiliated Hospital of Xi'an Jiaotong University
  • 以色列
      • Tel Aviv、以色列、64239
        • 招聘中
        • Tel Aviv Sourasky Medical Center
  • 日本
      • Nagoya、日本、467 8602
        • 主动，不招人
        • Nagoya City University Hospital
      • Shibuya City、日本、150-8935
        • 主动，不招人
        • Japanese Red Cross Medical Center
  • 比利时
      • Ghent、比利时、9000
        • 招聘中
        • UZ Gent
      • Leuven、比利时、3000
        • 招聘中
        • UZ Leuven
  • 法国
      • Nord、法国、59037
        • 招聘中
        • CHRU de Lille Hopital Claude Huriez
      • Paris、法国、75010
        • 招聘中
        • Hopital Saint Louis
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85054
        • 招聘中
        • Mayo Clinic Cancer Center-Scottsdale
    • California
      • Duarte、California、美国、91010
        • 招聘中
        • City of Hope
      • San Francisco、California、美国、94143
        • 招聘中
        • University of California San Francisco
      • Stanford、California、美国、94305-5623
        • 招聘中
        • Stanford University Medical Center
    • Florida
      • Tampa、Florida、美国、33612
        • 招聘中
        • Moffitt Cancer Center
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory University
    • Illinois
      • Chicago、Illinois、美国、60637
        • 招聘中
        • University of Chicago
      • Chicago、Illinois、美国、60611
        • 招聘中
        • Northwestern University
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Indiana University
    • Kansas
      • Westwood、Kansas、美国、66205
        • 招聘中
        • Kansas University Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Beth Israel Deaconess Medical Center
      • Boston、Massachusetts、美国、02115
        • 招聘中
        • Dana Farber Cancer Institute
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Massachusetts General Hospital
    • Michigan
      • Detroit、Michigan、美国、48201
        • 招聘中
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Rochester、Minnesota、美国、55902
        • 招聘中
        • Mayo Clinic Rochester
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University School Of Medicine
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • 招聘中
        • Hackensack University Medical Center
      • New Brunswick、New Jersey、美国、08903
        • 招聘中
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Buffalo、New York、美国、14263
        • 招聘中
        • Roswell Park Cancer Institute
      • New York、New York、美国、10065
        • 招聘中
        • Memorial Sloan Kettering Cancer Center
      • New York、New York、美国、10029
        • 招聘中
        • Mount Sinai Medical Center
      • The Bronx、New York、美国、10467
        • 招聘中
        • Montefiore Medical Center
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • 招聘中
        • Levine Cancer Institute
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • University of Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • 招聘中
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Sarah Cannon Research Institute
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • MD Anderson Cancer Center
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • 招聘中
        • Froedtert Memorial
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • 招聘中
        • VU Medisch Centrum
      • Groningen、荷兰、9713 GZ
        • 招聘中
        • University Medical Center Groningen
  • 西班牙
      • 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

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:

  • Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
  • Participants who have provided informed consent for this study

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：其他
  • 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：Cilta-cel

Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, NCT04133636, and NCT03548207) in the global development program will be enrolled into this study once the individual's participation in the particular interventional study has ended or a study has been terminated. Participants will not receive any treatment in this study and will be followed-up at least once per year on delayed adverse events for up to 15 years after receiving the last dose of cilta-cel.
药品：Cilta-cel

Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.

其他名称：
  • JNJ-68284528
  • LCAR-B38M CAR-T细胞

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 New Malignancies and Recurrence of Pre-existing Malignancy
大体时间：Up to 15 years

Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
Up to 15 years
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
大体时间：Up to 15 years

Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
Up to 15 years
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
大体时间：Up to 15 years

Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
Up to 15 years
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
大体时间：From year 1 up to year 5

Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.
From year 1 up to year 5
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
大体时间：From year 6 up to year 15

Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).
From year 6 up to year 15
Number of Participants with New Incidence of Grade >= 3 Infection
大体时间：From year 1 up to year 5

Number of participants with new incidence of Grade >=3 infection will be reported.
From year 1 up to year 5
Number of Participants with Serious Infection
大体时间：From year 6 up to year 15

Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.
From year 6 up to year 15
Number of Participants with Serious Adverse Events (SAEs)
大体时间：From year 1 up to year 5

A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
From year 1 up to year 5
Number of Participants with Related Serious Adverse Events Assessed by the Investigator
大体时间：From year 6 up to year 15

Number of participants with related serious adverse events assessed by the investigator will be reported. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
From year 6 up to year 15

次要结果测量

结果测量
措施说明
大体时间
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
大体时间：Up to 15 years

Number of participants with measurable RCL in peripheral blood will be reported.
Up to 15 years
Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
大体时间：Up to 15 years

Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.
Up to 15 years
Pattern of Lentiviral Vector Integration Sites
大体时间：Up to 15 years

Pattern of lentiviral vector integration sites if at least 1 percent (%) of cells in the blood sample or new malignancy are positive for vector sequences will be reported.
Up to 15 years
Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
大体时间：Up to 15 years

Investigator's response assessment of long term follow-up on CAR-T therapy based on local lab assessments if the participant does not have confirmed disease progression or does not initiate subsequent anti-myeloma therapy at the entry of the study and at any time of during the study will be reported.
Up to 15 years
Overall Survival (OS)
大体时间：Up to 15 years

OS is measured from the date of randomization to the date of the participant's death.
Up to 15 years

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

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)

2022年3月9日

初级完成 (估计的)

2037年7月29日

研究完成 (估计的)

2041年6月30日

研究注册日期

首次提交

2022年1月10日

首先提交符合 QC 标准的

2022年1月10日

首次发布 (实际的)

2022年1月21日

研究记录更新

最后更新发布 (实际的)

2026年11月3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

其他相关的 MeSH 术语

其他研究编号

  • CR109123
  • 2020-005521-84 (EudraCT编号)
  • 68284528MMY4002 (其他标识符：Janssen Research & Development, LLC)
  • 2023-505530-10-00 (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 the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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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