The Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall remission rate
研究概览
简要总结
Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.
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
- •Histological detection confirmed CD19/CD22 postive lymphoma;
- •Recieved more than 2 lines of chemotherapy;
- •Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
- •Life expectation for more than 3 months;
- •ECOG ≥ 2;
- •Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%;
- •CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
- •Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
- •With measurable disease;
- •Written informed consent could be acquired;
排除标准
- •Immunosuppressive agents or steroids in recent 1 week before recruitment;
- •Uncontrolled infection;
- •HIV positive ;
- •Active HBV or HCV infection;
- •Women in pregnancy and lactation;
- •Refuse to conception control during treatment and 1 year after CAR-T infusion;
- •Uncured malignancies other than non-Hodgkin lymphoma;
- •Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
- •Inheritated immune deficiancy;
- •Severe heart disease.
研究组 & 干预措施
CAR-T cell therapy
Patient-derived dual specificity CD19 and CD22 CAR-T
干预措施: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy (Biological)
结局指标
主要结局
Overall remission rate
时间窗: 4 weeks after infusion
Rate of complete remission and patial remission
次要结局
- Adverse toxicity(Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused)