NCT06355739招募中不适用
Phase II Clinical Study on the Safety and Efficacy of Autotransfusion Agents Targeting CD19 Chimeric Antigen Receptor T Lymphocytes (BIC-19GG, BIC-2019,BIC-2219)in the Treatment of CD19-positive Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Zhu Xiaofan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Overall survival and event-free survival
研究概览
简要总结
To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1, age 3-18 years old (including boundary value), male and female;
- •The patient was clinically diagnosed as relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoblastic
- •Patients with tumors who meet one of the following conditions:
- •Complete marrow response (MRD>1%) or not achieved after at least 2 courses of standardized induction regimen chemotherapy
- •Complete response at the molecular level and immunology (characterized by specific molecular markers and immunophenotypes prior to treatment)
- •Patients, did not turn negative after treatment);
- •Recurrence during chemotherapy, early recurrence after drug withdrawal (<12 months) or late recurrence after complete remission (≥
- •12 months) and did not achieve complete remission after 1 course of standard induction regimen (MRD>1%);
- •Recurrence after bone marrow transplantation;
- •Simple bone marrow, simple extramedullary (testicular leukemia, central nervous system leukemia) or combined
- •recrudescence
- •Lansky score ≥60;
- •4, the treatment related antigen test result is positive (CD19/CD20/CD22);
- •The expected survival period from the signing date of the informed consent is more than 3 months;
- •6, HGB≥70g/L (blood transfusion);
- •7, liver and kidney function, cardiopulmonary function meet the following requirements:
- •Creatinine ≤1.5×ULN;
- •Left ventricular ejection fraction ≥50%;
- •Blood oxygen saturation >90%;
- •Total bilirubin ≤1.5×ULN; ALT and AST≤2.5 x ULN.-
排除标准
- •1, severe cardiac insufficiency, left ventricular ejection fraction <50%;
- •2, have a history of severe lung function impairment;
- •Combined with other advanced malignant tumors;
- •4, combined with serious infection and can not be effectively controlled;
- •5, combined with serious autoimmune disease or congenital immune deficiency;
- •6, active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] positive);
- •7, human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- •Have a history of severe allergy to biological products (including antibiotics);
- •Patients with allogeneic hematopoietic stem cell transplantation still had acute graft-versus-host response (GvHD) one month after immunosuppressant discontinuation;
- •10, the presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in the study by the investigator.
结局指标
主要结局
Overall survival and event-free survival
时间窗: 24 months post CAR-T cell infusion
The prognosis of ALL children who underwent CAR-T cell therapy
次要结局
- Adverse events(12 months post CAR-T cell infusion)
- Overall remission rate(One month post CAR-T cell infusion)
研究者
Zhu Xiaofan
Head of department
Institute of Hematology & Blood Diseases Hospital, China
研究点 (2)
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