CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Best ORR
研究概览
简要总结
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell 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
- 14 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14 years to 85 years, expected survival > 3 months;
- •CD19/CD22 positive B-cell lymphoma or B-ALL;
- •relapsed or refractory to standard first-line treatment;
- •ECOG-PS score=0-2;
- •Having at least one measurable lesions;
- •Cardiac function: 1-2 levels;
- •Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
- •kidney: Cr≤1.25ULN;
- •bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
- •No serious allergic constitution;
- •No other serious diseases that conflicts with the clinical program;
- •No other cancer history;
- •No serious mental disorder;
- •Informed consent is signed by a subject or his lineal relation.
排除标准
- •Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- •Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- •Active hepatitis B or hepatitis C infection;
- •Recent or current use of glucocorticoid or other immunosuppressor;
- •With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- •Participate in other clinical research in the past three months;
- •previously treatment with any gene therapy products;
- •Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
研究组 & 干预措施
CD19/CD22 CAR-T group
Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19-CAR-T cell was 2×10e6/kg and CD22-CAR-T cell was 1×10e6/kg. Both CAR-T cells were infused at the same day.
干预措施: CD19/CD22-bispecific CAR-T cells (Drug)
结局指标
主要结局
Best ORR
时间窗: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Overall response rate means sum of complete response rate and partial response rate
次要结局
- Best CR rate(From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion)
- overall survival (OS)(From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion)
- Progression free survival (PFS)(From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion)
研究者
LIANG WANG
Director of the department of hematology
Beijing Tongren Hospital