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评估 Brexucabtagene Autoleucel (KTE-X19) 在复发/难治性套细胞淋巴瘤参与者中疗效的研究（队列 3） (ZUMA-2)

2026年7月24日 更新者：Kite, A Gilead Company

一项评估 KTE-X19 在复发/难治性套细胞淋巴瘤受试者中疗效的 2 期多中心研究

主要目的是评估 brexucabtagene autoleucel (KTE-X19) 对本研究队列 3 中复发/难治性 (r/r) 套细胞淋巴瘤 (MCL) 参与者的疗效。

研究概览

地位

完全的

条件

干预/治疗

详细说明

研究 KTE-C19-102 (NCT02601313) 招募了患有 r/r MCL 的参与者，他们在队列 1 和队列 2 中接受过多达 5 种既往治疗方案，包括布鲁顿氏酪氨酸激酶抑制剂 (BTKi)。但是，为了满足 FDA 上市后要求队列3 被添加到研究中。 它将包括患有 r/r MCL 的参与者，他们接受过多达 5 种先前的治疗方案，但没有接受过 BTKi 的先前治疗。

队列 1 和队列 2 的主要分析已经完成。 队列 3 的数据将单独分析。 因此，此单独注册仅适用于队列 3。

在 KTE-C19-102 结束后，接受抗 CD19 CAR T 细胞输注的受试者将在另一项长期随访研究 KT-US 中完成剩余的 15 年随访评估。 982-5968

研究类型

介入性

注册 (实际的)

95

阶段

  • 阶段2

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

  • 德国
      • Mainz、德国、55101
        • Johannes Gutenberg University Hospital-University Mainz
      • München、德国、81377
        • Munich University of Technology-Medical Faculty- Ethics Committee
      • Würzburg、德国、97080
        • Universitaetsklinikum Wuerzburg
  • 法国
      • Montpellier、法国、34295
        • CHU de Montpellier
      • Paris、法国、75010
        • Hospital Saint Louis
      • Pessac、法国、44035
        • Hôpital Haut-Lévêque
      • Pierre-Bénite、法国、69495
        • Centre Hospitalier LYON SUD
      • Rennes、法国、35033
        • CHU de Rennes
  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
        • Banner MD Anderson Cancer Center
    • California
      • Palo Alto、California、美国、94305
        • Stanford University
      • Santa Monica、California、美国、90404
        • University California Los Angeles (UCLA)
    • Colorado
      • Denver、Colorado、美国、80218
        • Sarah Cannon- Denver
    • Florida
      • Miami、Florida、美国、33136
        • University of Miami
      • Tampa、Florida、美国、33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University
    • Illinois
      • Chicago、Illinois、美国、60637
        • University of Chicago
      • Maywood、Illinois、美国、60153
        • Loyola University Medical Center
      • Park Ridge、Illinois、美国、60068
        • Advocate Aurora Health - Advocate Lutheran General Hospital
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit、Michigan、美国、48201
        • Karmanos Cancer Institute
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • Hackensack University Medical Center
    • New York
      • Rochester、New York、美国、14642
        • University of Rochester
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic - Taussig Cancer Institute
      • Columbus、Ohio、美国、43220
        • Ohio State University
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University
      • Nashville、Tennessee、美国、37203
        • Sarah Cannon - Tenessee
    • Texas
      • Dallas、Texas、美国、75246
        • Baylor Cancer Hospital
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle、Washington、美国、98104
        • Swedish Cancer Institute
  • 英国
      • Glasgow、英国、G51 4TF
        • Queen Elizabeth University Hospital
      • London、英国、SE5 9RS
        • Kings College Hospital
      • Manchester、英国、M13 9WL
        • Manchester Royal Infirmary
  • 荷兰
      • Amsterdam、荷兰、1100
        • Academisch Medisch Centrum
      • Groningen、荷兰、9700 RB
        • University Medical Center Groningen
      • Rotterdam、荷兰、3015 CE
        • Erasmus MC
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona、西班牙
        • Hospital Clinic Barcelona
      • Salamanca、西班牙、37007
        • Hospital Universitario 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

描述

关键纳入标准：

  • 最多 5 个先前的 MCL 方案。 既往治疗必须包括含蒽环类药物或苯达莫司汀的化疗和抗 CD20 单克隆抗体治疗。 个人之前不得接受过 BTKi 治疗。
  • 至少 1 个可测量的病灶
  • 血小板计数 ≥ 75,000/uL
  • 肌酐清除率（由 Cockcroft Gault 估计）≥ 60 cc/min
  • 心脏射血分数 ≥ 50%，超声心动图 (ECHO) 或多门采集 (MUGA) 确定无心包积液证据，且无临床意义的心电图 (ECG) 结果
  • 室内空气基线氧饱和度 > 92%

关键排除标准：

  • 已知的人类免疫缺陷病毒 (HIV) 或乙型肝炎病毒（HBsAG 阳性）或丙型肝炎病毒（抗-HCV 阳性）感染史。 有肝炎感染史的人必须通过标准血清学和基因检测确定已清除感染
  • 癫痫病史、脑血管缺血/出血、痴呆、小脑疾病、脑水肿、后部可逆性脑病综合征或任何累及中枢神经系统 (CNS) 的自身免疫性疾病
  • 存在真菌、细菌、病毒或其他不受控制或需要静脉注射抗菌药物进行管理的感染

注意：其他协议定义的包含/排除标准可能适用。

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：Brexucabtagene autoleucel (KTE-X19)

Participants with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have been treated with up to 5 prior regimens but have not received prior therapy with a Bruton's tyrosine kinase inhibitor (BTKi) will receive the following treatment during the study:

  • A conditioning chemotherapy regimen of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day for 3 days (Day -5 to Day -3).
  • A single infusion of brexucabtagene autoleucel at a target dose of 2×10^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg, with a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells for participants > 100 kg on Day 0.
药品：Fludarabine
Administered as intravenous infusion
药品：Cyclophosphamide
Administered as intravenous infusion
生物：Brexucabtagene autoleucel
Administered as intravenous infusion
其他名称：
  • Tecartus™
  • KTE-X19

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
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 3
大体时间：Up to 4 years
OR: complete metabolic response (CMR),complete radiological response (CRR), partial MR response (PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤mediastinum)/3(uptake >mediastinum but ≤liver) with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to ≤1.5cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal;no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately >liver)/5(uptake markedly >liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT). PRR: ≥50% decrease in sum of the product of the diameters(SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by >50% in length beyond normal.
Up to 4 years

次要结果测量

结果测量
措施说明
大体时间
具有抗 CD19 CAR 抗体的参与者的百分比
大体时间：基线直至第 3 个月
基线直至第 3 个月
血液中 C 反应蛋白 (CRP) 的血清峰值水平
大体时间：基线至第 4 周
峰值定义为细胞因子的最大基线后水平。
基线至第 4 周
Duration of Response (DOR) Per the Lugano Classification According to IRRC in Cohort 3
大体时间：Up to 4 years
DOR: time from the first OR to progressive disease (PD)/death. It was determined using Kaplan-Meier (KM) estimates. PD: score 4 (uptake moderately > liver)/ 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi > 1.5 cm, increase by ≥ 50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement.
Up to 4 years
Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
大体时间：Up to 4 years
BOR consisted of complete response (CR), partial response (PR), stable disease (SD), PD, not done and not evaluable (NE). CR=CMR/CRR and PR=PMR/PRR were defined in Outcome Measure (OM) 1. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than (>) liver) or 5 (uptake markedly >liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed. PD was defined in OM 2. Not done: no assessment at the time of analysis. Clopper-Pearson method was used for OM analysis. Percentages were rounded off.
Up to 4 years
Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
大体时间：Up to 4 years
OR was defined in OM #1. Percentages were rounded-off.
Up to 4 years
Progression Free Survival (PFS) Per the Lugano Classification According to IRRC in Cohort 3
大体时间：Up to 4 years
PFS was defined as the time from brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD was defined in OM #2. Kaplan-Meier (KM) estimates were used for analysis.
Up to 4 years
Overall Survival (OS)
大体时间：Up to 4 years
OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. KM estimates were used for analysis.
Up to 4 years
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to 3 years
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participants. The event did not necessarily have a relationship with study treatment. AE included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while on study, was not considered an AE. TEAE was defined as any AE with onset on or after the start of treatment.
Up to 3 years
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
大体时间：Up to 3 years
Laboratory results were graded according to National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE) version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
大体时间：Up to 3 years
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
大体时间：Up to 3 years
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
大体时间：Up to 3 years
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Maximum Number of CAR T Cells Measured Post-infusion
大体时间：Up to Month 36
Up to Month 36
Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-gamma (IFN-γ), Interleukin (IL)-1 Receptor Antagonist (RA), IL-2, IL-6, IL-7, IL-8, IL-10, IL-15 and Tumor Necrosis Factor (TNF)-α in Blood
大体时间：Baseline up to Week 4
Peak was defined as the maximum post-baseline level of the cytokine.
Baseline up to Week 4
Peak Serum Levels of Ferritin, Intercellular Adhesion Molecule (ICAM)-1, IL-2 Receptor Alpha (Rα), Perforin and Vascular Cell Adhesion Molecule (VCAM)-1 in Blood
大体时间：Baseline up to Week 4
Peak was defined as the maximum post-baseline level of the cytokine.
Baseline up to Week 4
Percentage of Participants With European Quality of Life-5 Dimensions (EQ-5D) Scale Score at Different Timepoints
大体时间：Day 0, Month 18 and Month 24
The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) was a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant was asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, were converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. Percentage of participants with each scale score for all 5 dimensions are reported. Percentages were rounded-off.
Day 0, Month 18 and Month 24
EQ-5D Visual Analogue Scale (VAS) Score at Different Timepoints
大体时间：Day 0, Month 18 and Month 24
EQ-5D was a standardized participant completed questionnaire that measures health-related quality of life and translated the score into an index value or utility score. EQ-5D-consisted of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5D-VAS recorded the participant's self-rated health on a vertical visual analogue scale, where the endpoints were labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicated better self-reported health status.
Day 0, Month 18 and Month 24
Percentage of Participants With Deterioration Scores From Screening in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
大体时间：Screening Day -28 to Leukapheresis (Day -5), Day 0, Month 18 and Month 24
EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status/quality of life (QoL) scale, symptom scales (fatigue, pain, nausea/vomiting), and single items scales (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores are averaged, transformed to 0-100 scale. Higher scores for functional scales and for the global health status/QoL scale indicate a higher level of functioning and a better health-related QoL, whereas higher scores in symptom scales represent a higher level of symptoms. Deterioration of score was defined as worsened by at least 1 level from screening. Participants with answer "Yes" to the EORTC functional scale questionnaire were reported.
Screening Day -28 to Leukapheresis (Day -5), Day 0, Month 18 and Month 24

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

Kite, A Gilead Company

调查人员

  • 研究主任：Kite Study Director、Kite, A Gilead Company

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

有用的网址

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4月23日

初级完成 (实际的)

2025年6月17日

研究完成 (实际的)

2025年6月17日

研究注册日期

首次提交

2021年4月30日

首先提交符合 QC 标准的

2021年5月5日

首次发布 (实际的)

2021年5月10日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7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

  • KTE-C19-102 (Cohort 3)
  • 2015-005008-27 (EudraCT编号)
  • 2023-506641-35 (其他标识符：European Medicines Agency)

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

Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

IPD 共享时间框架

18 months after study completion and at least 6 months after the FDA and EMA approval

IPD 共享访问标准

A secured external environment with username, password, and RSA code.

IPD 共享支持信息类型

  • 研究方案
  • 树液

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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