NCT07606937招募中1 期
A Single-arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel Injection Manufactured by an Automated Process in Patients With Relapsed/Refractory Large B-cell Lymphoma.
Shenzhen Fosun Kairos Biotechnology Co., Ltd.6 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年6月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 6
研究概览
简要总结
This study is a single-arm, multicenter, open-label clinical study evaluating the efficacy and safety of axicabtagene ciloleucel injection manufactured by an automated cell preparation process in adult subjects with relapsed or refractory large B-cell lymphoma (r/r LBCL) as second-line therapy.
详细描述
This study is a single-arm, multicenter, open-label clinical study evaluating the efficacy and safety of axicabtagene ciloleucel injection manufactured by an automated cell preparation process in adult subjects with relapsed or refractory large B-cell lymphoma (r/r LBCL) as second-line therapy. A total of 12 adult subjects with r/r LBCL who are refractory to first-line immunochemotherapy or who relapse within 12 months after first-line immunochemotherapy will be enrolled. All subjects will undergo leukapheresis, bridging therapy, conditioning chemotherapy, and a single study drug infusion.
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
- •Age 18 years or older at the time of informed consent
- •Has signed the informed consent form (ICF)
- •Histologically proven large B-cell lymphoma
- •Relapsed or refractory disease after first-line chemoimmunotherapy
- •The subject has at least one measurable lesion on imaging
- •No clinical or historical evidence suggestive of lymphoma involvement of the central nervous system (CNS)
- •A washout period of at least 2 weeks or 5 half-lives (whichever is shorter) from the last prior systemic therapy to the signing of the informed consent form.
- •Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1
- •ECOG performance status of 0 or 1
- •Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
- •Female subjects of childbearing potential must have a negative serum pregnancy test . Male and female subjects of childbearing potential must agree to use highly effective contraception during the study and for 6 months post-infusion.
排除标准
- •Prior history of other malignancies, with the exception of non-melanoma skin tumors, carcinoma in situ , or follicular lymphoma that have been free of recurrence for more than 3 years.
- •History of Richter's transformation of CLL or PMBCL
- •History of autologous or allogeneic stem cell transplant
- •Received more than one line of therapy for DLBCL
- •Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel
- •Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
- •History of severe, immediate hypersensitivity reaction attributed to aminoglycosides or Tocilizumab
- •Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management
- •Known history of infection with human immunodeficiency virus (HIV) or Positive test result for anti-Treponema pallidum antibody (TP-Ab) or hepatitis B(HBsAg positive) or hepatitis C virus (anti-HCV positive)
- •Active tuberculosis
- •Presence of any indwelling line or drain
- •Subjects with detectable malignant cells in the cerebrospinal fluid (CSF) or known brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases
- •History or presence of non-malignant CNS disorder
- •Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
- •History of clinically significant cardiac disease within 12 months of enrollment
- •Requirement for urgent therapy within 6 weeks due to tumor mass effects, such as bowel obstruction or blood vessel compression or airway obstruction
- •Patients with idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on chest CT are excluded.
- •History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- •Women of childbearing potential who are pregnant or breastfeeding
- •In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
研究者
研究点 (6)
Loading locations...
相似试验
招募中
不适用
Retrograde Ascending Dissection: Intraluminal Aortic TherapyNCT07405242Ruijin Hospital149
进行中（未招募）
4 期
A Clinical Study of GutBio Capsule for the treatment of Irritable Bowel Syndrome and its symptoms.CTRI/2024/05/067532Healing Hands &Herbs Pvt Ltd.100
招募中
不适用
Electric Stimulation Home Use(CGM MEPC_2401) for Improving Blood CirculationNCT07446088Ceragem Clinical Inc.40
招募中
2/3 期
Clinical Study on Gynoveda Ayurvedic Formulations in Female InfertilityCTRI/2025/11/097011Gynoveda Femtech Pvt. Ltd200
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