2024-519394-19-00招募中2 期
Measurable residual disease driven strategy for one or two infusions of nonviral, transposon-manipulated CARCIK CD19 cells. A Phase II study in pediatric and adult patients with relapsed/refractory B cell precursor ALL (BCP-ALL).
Fondazione Tettamanti2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年12月10日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- ORR at 28 days after the first CARCIK-CD19 administration
研究概览
简要总结
To confirm the high overall response rate at day 28 after the first CARCIK-CD19 infusion and to improve the duration of response of patients treated with CARCIK -CD19 cells.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Children (1-17) and adults (18-75 years old);
- •Absence of severe renal disease (creatinine > x 3 normal for age);
- •Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500);
- •Patient/guardian able to give informed consent.
- •Relapsed or refractory adult and pediatric BCP-ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR;
- •Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- •Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening, or if <5%, with at least 1% of molecular disease at PCR;
- •No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
- •No longer taking immunosuppressive agents for at least 30 days prior to infusion;
- •No evidence of concomitant life-threatening infectious disease;
- •Life expectancy > 60 days;
- •Lansky/Karnofsky scores > 60;
排除标准
- •GVHD Grades II-IV for patients who had previously been transplanted;
- •Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia;
- •Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible
- •Any cell therapy in the last 30 days;
- •Patient with concomitant life-threatening infectious disease;
- •Lansky/Karnofsky score <60;
- •Patients with hepatic or renal disease as specific above;
- •Pregnant or breast feeding females;
- •Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
- •Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met;
- •HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG);
结局指标
主要结局
ORR at 28 days after the first CARCIK-CD19 administration
ORR at 28 days after the first CARCIK-CD19 administration
DOR from day 70 for patients who achieved and maintained remission after the first or the second CARCIK-CD19 administration
DOR from day 70 for patients who achieved and maintained remission after the first or the second CARCIK-CD19 administration
次要结局
- Overall survival (i. e. time from infusion to death)
- Safety of the second administration of allogeneic CARCIK-CD19 cells
- Safety of autologous CARCIK-CD19 cells
- Safety of cordblood CARCIK-CD19 cells.
研究者
Giuseppe Dastoli
Scientific
Fondazione Tettamanti
研究点 (2)
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