NCT05388695招募中1 期
To Observe the Long-term Efficacy and Safety of Dual-target Chimeric Antigen Receptor T Cells in the Treatment of Refractory Relapsed B Cell Hematologic Tumors
Hebei Senlang Biotechnology Inc., Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy: Remission Rate
研究概览
简要总结
To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).
详细描述
This study is open single-arm prospective clinical study To relapse/refractory blood B cell tumor patients as the subjects, according to the expression of tumor cells, gives the corresponding double targets CART cell injection treatment, follow-up observation of the adverse reactions and the treatment effect of the drug to the data (at least 2 years), assessment of double targets CAR - T Long-term efficacy and safety of cell injection
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);
- •CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;
- •4.Estimated survival time>3 months; 5.ECOG Scores: 0~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.
排除标准
- •With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;
- •Presence of other malignant tumors;
- •There are severe infections that cannot be effectively controlled;
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;
- •Known positive serology for human immunodeficiency virus (HIV) or syphilis;
- •A history of severe allergies to biological products (including antibiotics);
- •Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);
- •Female patients who are under pregnancy and/or lactation;
- •Active autoimmune disease requiring systemic immunosuppressive therapy;
- •Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.
研究组 & 干预措施
19+22 CART and 19+20 CART
Experimental
Eligible patients will be treated with 19+22 CAR-T and 19+20 CAR-T.
干预措施: Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells (Biological)
结局指标
主要结局
Efficacy: Remission Rate
时间窗: Up to 3 months
Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
次要结局
未报告次要终点
研究者
研究点 (1)
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