EUCTR2017-000900-38-IT进行中（未招募）1 期
Open label, single arm, multicenter, dose escalation Phase I-IIa, trial to determine the safety of Allogeneic (donor derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene (CARCIK.CD19) in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), after Hematopoietic Stem Cell Transplantation (HSCT) - Transposon-manipulated Allogeneic CARCIK-CD19 cells in Pediatric and Adult Patients with r/r ALL pos
FONDAZIONE TETTAMANTI M.DE MARCHI ONLUS0 个研究点目标入组 21 人开始时间: 2021年1月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Children and adults (1-75 years old);
- •2.Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
- •3.Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- •4.Bone marrow with = 5% lymphoblasts by morphologic assessment at screening ;
- •5.No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
- •6.No longer taking immunosuppressive agents for at least 30 days prior to enrollment;
- •7.No evidence of concomitant life-threatening infectious disease;
- •8.Life expectancy > 60 days;
- •9.Lansky/Karnofsky scores > 60;
- •10.Absence of severe renal disease (creatinine > x 3 normal for age);
- •11.Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500);
- •12.Patient/guardian able to give informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Patients with GVHD Grades II-IV;
- •2.Any cell therapy in the last 30 days;
- •3.Patient with concomitant life-threatening infectious disease ;
- •4.Lansky/Karnofsky score <60;
- •5.Patients with hepatic or renal disease as specific above;
- •6.Pregnant or breast feeding females;
- •7.Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
- •8.Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met.;
- •9.HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG);
- •10.Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia;
- •11.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
- •12.Patient has received an investigational medicinal product within the last 30 days prior to screening
- •13.Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- •14.Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CARCIK-CD19 infusion.
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