Clinical Study of the Efficacy and Safety of Chimeric Antigen Receptor T-cell Therapy Following Autologous Stem Cell Transplantation for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.
详细描述
Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years.
- •Pathological immunohistochemistry or flow cytometry confirmed that R/ R Large B-cell Non-Hodgkin's Lymphoma with measurable (the longest diameter greater than 1.5cm and the longest vertical diameter greater than 1.0cm) lesions.
- •Previously treated with 1 or more lines of therapy.
- •The main organ functions need to meet the following conditions:LVEF≥50%;CCr≥30 ml/min; ALT and AST≤3 times normal range.
- •Hematopoietic function needs to meet the following conditions: platelet count≥45×10^9/L; hemoglobin≥8.0 g/dL; absolute neutrophil count≥1.0×10^9/L.
- •Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.
- •Estimated survival time ≥3 months.
- •Voluntary signing of informed consent and good compliance.
排除标准
- •Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent.
- •The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
- •Active hepatitis B or active hepatitis C.
- •HIV infection.
- •Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent.
- •Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma).
- •Pregnant or breasting-feeding women.
- •There is evidence of complications or medical conditions that could interfere with the conduct of the study or put patients at serious risk, including but not limited to serious cardiovascular disease.
- •Conditions deemed by the researchers to be inappropriate for participation.
研究组 & 干预措施
ASCT+CAR-T
Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.
干预措施: CAR-T Cell Therapy (Drug)
ASCT+CAR-T
Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.
干预措施: Apheresis (Other)
ASCT+CAR-T
Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy.
干预措施: Autologous Stem Cell Transplantation (Other)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to 24 months
Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy.
Progression-free Survival（PFS）
时间窗: Up to 24 months
PFS is defined as the time from ASCT to progression, death or the last follow-up point
次要结局
- Duration of Response(DOR)(Up to 24 months)
- Complete Response Rate(Up to 24 months)
- Overall Survival（OS）(Up to 24 months)
- Adverse events profile(Up to 24 months)