NCT07344818招募中1 期
An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- the safety of CD19⁺CD20 CAR-T therapy
研究概览
简要总结
To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma
详细描述
In this study, anti-CD19 and anti-CD20 dual target CAR-T cell therapy will be explored for patients with relapsed/refractory aggressive B-cell lymphoma. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of dual-target CAR-T cells in r/r B-NHL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。
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
- •The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
- •Male or female subjects aged ≥18 years at the time of signing the ICF.
- •An expected life expectancy of at least 12 weeks.
- •An ECOG performance status of 0-2 at the time of signing the ICF.
- •A diagnosis of relapsed or refractory aggressive B-cell lymphoma at the time of signing the ICF. Subjects must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other CD20-targeted agents), and must have experienced relapse or progression after at least two prior lines of therapy or autologous hematopoietic stem cell transplantation (ASCT).
- •Presence of measurable positive lesions as defined by the Lugano criteria.
- •Lymphoma lesions confirmed by biopsy to screening demonstrating expression of CD19 and/or CD
- •Adequate major organ function.
- •contraception.
排除标准
- •Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma).
- •History of CNS disorders.
- •History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF.
- •Presence of any uncontrolled active infection at the time of signing the ICF or within 2 weeks prior to leukapheresis, requiring antibiotic, antiviral, or antifungal treatment.
- •Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus (CMV) DNA、Positive Epstein-Barr virus (EBV) DNA、Positive both treponemal-specific and non-specific serologic tests for syphilis.
- •Clinically significant cardiovascular disease.
- •Known hypersensitivity to any component of the investigational products used in this study.
- •Receipt of any disease-related investigational therapy or other systemic antitumor therapy prior to leukapheresis and within 5 half-lives of the drug.
- •Requirement for systemic corticosteroids (at a dose equivalent to ≥20 mg/day of prednisone) or other immunosuppressive agents within 2 weeks prior to signing the ICF, within 2 weeks prior to leukapheresis, or during the study.
- •Major surgery (excluding routine biopsy) within 4 weeks prior to signing the ICF, or planned major surgery during the study period.
- •History of another primary malignancy within 5 years prior to signing the ICF, except for:
- •Adequately treated and cured carcinoma in situ of the cervix;
- •Localized basal cell carcinoma or squamous cell carcinoma of the skin.
- •Receipt of a live attenuated vaccine within 4 weeks prior to signing the ICF, or planned vaccination with a live attenuated vaccine during the screening period.
- •Any condition or complication that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation in the study.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
CAR-T cells therapy
Experimental
eligible patients will be treated with CD19+CD20 dual CAR-T cells
干预措施: CAR-T cell therapy (Biological)
结局指标
主要结局
the safety of CD19⁺CD20 CAR-T therapy
时间窗: 1 year after CAR-T cells therapy
To evaluate the incidence and severity of AEs and SAEs in the treatment of relapsed or refractory CD19 and/or CD20 positive aggressive B-cell lymphoma patients after infused the CD19+CD20 CAR-T cells
次要结局
未报告次要终点
研究者
Xiao-Jun Huang
Associate Chief Physician, Peking University Institute of Hematology
Peking University People's Hospital
研究点 (1)
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