NCT07622784尚未招募2 期
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
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年6月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究者
Qingqing Cai
Professor and Chief Physician
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Retrograde Ascending Dissection: Intraluminal Aortic TherapyNCT07405242Ruijin Hospital149
招募中
1 期
A Study of Automated Axicabtagene Ciloleucel for R/R Large B-cell Lymphoma.NCT07606937Shenzhen Fosun Kairos Biotechnology Co., Ltd.12
尚未招募
不适用
A study to evaluate the efficacy of test regime in adult males with male pattern baldness.CTRI/2025/07/091602Anveya Living Private Limited50
尚未招募
不适用
A study to evaluate the efficacy of test regime in adult females suffering from hair loss.CTRI/2025/07/090415Anveya Living Private Limited50
尚未招募
不适用
Clinical Study on the Effects of VC-KON™ Vegan Collagen Supplement on Skin, Hair, Nails, and Joint Health in Healthy AdultsCTRI/2026/02/104931Konark Herbal & HealthCare Pvt. Ltd.30