Humanized CAR-T Therapy for Treatment of Recurrent or Refractory B Cell Malignancy by Targeting CD19
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- CAR-T cells persistence in peripheral blood
研究概览
简要总结
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.
详细描述
CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥3 at the time of consent
- •Survival time>12 weeks
- •B cell hematological malignancies by pathological examination
- •Chemotherapy failure or recurrent B cell malignancy
- •Creatinine< 2.5mg/dl
- •Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
- •Karnofsky Performance Status>50% at the time of screening
- •Bilirubin<2.0mg/dl
- •Adequate pulmonary, renal, hepatic, and cardiac function
- •Fail in autologous or allogenic haemopoietic stem cell transplantation
- •Free of leukocytes removal contraindications
排除标准
- •Pregnant or nursing women
- •Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
- •Previous treatment with any gene therapy product
- •Abnormal vital signs
- •Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
- •General infection or local severe infection, or other infection that is not controlled
- •Dysfunction in lung, heart, kidney and brain.
- •Severe autoimmune diseases
- •other symptoms that are not applicable for CAR-T
研究组 & 干预措施
CAR-T
In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.
干预措施: CAR-T (Biological)
结局指标
主要结局
CAR-T cells persistence in peripheral blood
时间窗: 12 months
The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR
次要结局
- B cell number and immunoglobulins in peripheral blood(12 months)
研究者
Kai Lin Xu; Jun Nian Zheng
President
Xuzhou Medical University