Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma
2026年5月28日 更新者：Qingqing Cai、Sun Yat-sen University
A Single-Arm, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pirtobrutinib as Maintenance Therapy for Relapsed or Refractory B-Cell Lymphoma After CAR-T Cell Therapy
This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of pirtobrutinib as maintenance therapy in patients with relapsed or refractory B-cell lymphoma after commercial anti-CD19 CAR-T cell therapy.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
20
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
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Sun Yat-sen University Cancer Center
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接触：
- Principal investigator
- 电话号码：0086-20-87342823
- 邮箱：caiqq@sysucc.org.cn
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Able to understand and voluntarily sign the informed consent form.
- Age 18 years or older, male or female.
- Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or transformed follicular lymphoma (tFL).
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Has received commercial anti-CD19 CAR-T cell therapy, with informed consent obtained before Day 28 after CAR-T cell infusion.
- Prior anti-lymphoma therapy-related adverse events, especially CAR-T-related adverse events, have stabilized and recovered to Grade 1 or lower, except for clinically insignificant toxicities.
Exclusion Criteria:
- History of other malignancies, except non-melanoma skin cancer without recurrence for more than 3 years, carcinoma in situ, such as cervical, bladder, or breast carcinoma, or follicular lymphoma.
- Prior autologous or allogeneic hematopoietic stem cell transplantation.
- Active or suspected uncontrolled fungal, bacterial, viral, or other infection requiring intravenous treatment. Patients with uncomplicated urinary tract infection or uncomplicated bacterial pharyngitis may be enrolled if responding to active treatment.
- History of immunodeficiency, including human immunodeficiency virus infection; positive treponema pallidum antibody; active hepatitis B virus infection; or active hepatitis C virus infection.
- Current or prior history of benign central nervous system disease, such as seizure, cerebrovascular ischemia or hemorrhage, dementia, cerebellar disease, or any central nervous system-related autoimmune disease.
- Lymphoma involvement of the atrium or ventricle.
- Autoimmune disease requiring systemic immunosuppressive or immunomodulatory therapy within 2 years.
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment.
- Any comorbidity that may affect or interfere with safety or efficacy assessment.
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 |
|---|---|
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实验性的：Pirtobrutinib Maintenance After CAR-T Cell Therapy
Patients will receive pirtobrutinib 200 mg orally once daily starting on Day 30 after commercial anti-CD19 CAR-T cell infusion.
Pirtobrutinib maintenance therapy will be continued for 6 months unless disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria occur.
Patients who do not achieve complete response after 6 months of maintenance therapy, or who achieve complete response with detectable ctDNA, may receive a second infusion of commercial CAR-T cells at the investigator's discretion.
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Pirtobrutinib will be administered orally at a dose of 200 mg once daily for 6 months, beginning on Day 30 after commercial anti-CD19 CAR-T cell infusion.
Dose interruption, dose reduction, or treatment discontinuation will be performed according to protocol-specified toxicity management rules.
A second infusion of commercial anti-CD19 CAR-T cells may be administered after completion of 6 months of pirtobrutinib maintenance therapy in selected patients who do not achieve complete response, or who achieve complete response but remain ctDNA-positive, based on investigator assessment and protocol-defined criteria.
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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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Complete response rate (CRR)
大体时间：At 6 months after initiation of pirtobrutinib maintenance therapy
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CRR is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria at 6 months after initiation of pirtobrutinib maintenance therapy.
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At 6 months after initiation of pirtobrutinib maintenance therapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall survival (OS)
大体时间：Up to 24 months
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OS is defined as the time from enrollment to death from any cause.
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Up to 24 months
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Best complete response rate (bCRR)
大体时间：Up to 24 months
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bCRR is defined as the proportion of patients whose best response is complete response according to the Lugano 2014 criteria.
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Up to 24 months
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Best objective response rate (bORR)
大体时间：Up to 24 months
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bORR is defined as the proportion of patients whose best response is complete response or partial response according to the Lugano 2014 criteria.
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Up to 24 months
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Objective response rate (ORR)
大体时间：At 6 months after initiation of pirtobrutinib maintenance therapy
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ORR is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria at 6 months after initiation of pirtobrutinib maintenance therapy.
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At 6 months after initiation of pirtobrutinib maintenance therapy
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Duration of complete response (DoCR)
大体时间：Up to 24 months
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DoCR is defined as the time from the first documented complete response to disease progression or death from any cause, whichever occurs first.
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Up to 24 months
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Duration of response (DOR)
大体时间：Up to 24 months
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DOR is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.
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Up to 24 months
|
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Progression-free survival (PFS)
大体时间：Up to 24 months
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PFS is defined as the time from enrollment to disease progression or death from any cause, whichever occurs first.
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Up to 24 months
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Incidence of adverse events (AEs) and serious adverse events (SAEs)
大体时间：Up to 30 days after the last dose of pirtobrutinib
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The incidence and severity of adverse events will be assessed and graded according to the National Cancer In Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
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Up to 30 days after the last dose of pirtobrutinib
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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。
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 (估计的)
2026年6月1日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年5月28日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
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.