复发或难治性 B 细胞非霍奇金淋巴瘤 (r/r B-NHL) 中的 C-CAR066
C-CAR066 的 Ib 期多中心、开放标签研究，一种自体抗 CD20 CAR T 细胞治疗成人复发或难治性 B 细胞非霍奇金淋巴瘤患者
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:
- can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
- will JNJ-90009530 help patients achieve a response and for how long?
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Jerusalem、以色列、9112001
- Hadassah Medical Center
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Ramat Gan、以色列、5266202
- Sheba Medical Center
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Camperdown、澳大利亚、2050
- Royal Prince Alfred Hospital
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Clayton、澳大利亚、3168
- Monash Medical Centre
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Heidelberg、澳大利亚、3084
- Austin Hospital
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Herston、澳大利亚、4029
- Royal Brisbane and Women's Hospital
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Westmead、澳大利亚、2145
- Westmead Hospital
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa Hospital
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Kentucky
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Lexington、Kentucky、美国、40506
- University of Kentucky
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic Rochester
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New Jersey
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New Brunswick、New Jersey、美国、08901
- Rutgers University
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Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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Texas
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Houston、Texas、美国、77030
- MD Anderson Cancer Center
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London、英国、NW1 2BU
- University College London Hospitals
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria
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Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
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All participants must have relapsed or refractory disease for each histologic subtype
- Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy or >=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent
- Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have >=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
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Tumor must be cluster of differentiation (CD) 20 positive
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Measurable disease as defined by Lugano 2014 classification
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Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1
Key Exclusion Criteria
- Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL)
- Prior allogeneic Hematopoietic stem cell transplantation (HSCT)
- Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
- Uncontrolled active infections
- History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])
- History of stroke, unstable angina, myocardial infarction, congestive heart failure ( New York Heart Association [NYHA] Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
- History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder
- Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
- Active central nervous system (CNS) involvement by malignancy
- Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
学习计划
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：JNJ-90009530
|
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
其他名称：
|
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 |
|---|---|---|
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Calculate the Occurence of Adverse Events
大体时间：up to 24 months
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The safety and tolerability will be measured by recording the occurence and severity of all adverse events or dose limiting toxicities that occur according to Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0 |
up to 24 months
|
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Determine Recommended Phase 2 dose (RP2D)
大体时间：up to 24 months
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Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities |
up to 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Determine the Overall Response (OR)
大体时间：up to 24 months
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Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014 |
up to 24 months
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Determine the time to response (TTR)
大体时间：up to 24 months
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Record the number of days from the date of JNJ-90009530 infusion to a CR or PR |
up to 24 months
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Determine the duration of response (DOR)
大体时间：up to 24 months
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Record the number of days from the date of the first CR or PR to relapse or death. |
up to 24 months
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Measure the amount of JNJ-90009530 in blood over time
大体时间：up to 24 months
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Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR). |
up to 24 months
|
合作者和调查者
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- 90009530LYM1001
- 90009530LYM1001 (其他标识符：Janssen Research & Development, LLC)
- 2023-506259-97-00 (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)？
IPD 计划说明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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
研究美国 FDA 监管的设备产品
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.