NCT03118180Unknown1 期
The Safety and Efficacy Evaluation of CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma
Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.
详细描述
A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma. Complete remission rate, overall survival rate, relapse rate and CRS rate were monitored. CART associated toxicities were also monitored.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed aggressive B cell lymphoma
- •Chemotherapy-refractory disease, defined as one or more of the following:
- •No response to first-line therapy (primary refractory disease); PD as best response to first-line therapy SD as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R- CHOP) with SD duration no longer than 6 months from last dose of therapy OR No response to second or greater lines of therapy PD as best response to most recent therapy regimen SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy OR Refractory post-ASCT Disease progression or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
- •Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)
- •Age 18 or older
- •Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- •ANC ≥1000/uL
- •Platelet count ≥75,000/uL
- •Absolute lymphocyte count ≥100/uL
- •Adequate renal, hepatic, pulmonary and cardiac function defined as:
- •Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min Serum ALT/AST ≤2.5 ULN Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome. Cardiac ejection fraction ≥ 50% ,no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings No clinically significant pleural effusion Baseline oxygen saturation >92% on room air
- •Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
排除标准
- •History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
- •History of Richter's transformation of CLL
- •Autologous stem cell transplant within 6 weeks of planned CAR-C19 infusion
- •History of allogeneic stem cell transplantation
- •Prior CD19 targeted therapy with the exception of subjects who received CAR-C19 in this study and are eligible for re-treatment
- •Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
- •History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- •Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the K Medical Monitor.
- •Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti- HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
- •Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
- •Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
- •History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- •Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
- •History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- •Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
- •Primary immunodeficiency
- •History of deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- •Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
- •History of severe immediate hypersensitivity reaction to any of the agents used in this study
- •Live vaccine ≤ 6 weeks prior to start of conditioning regimen
- •Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
- •Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of CAR-C19
- •In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
- •History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
结局指标
主要结局
overall response rate
时间窗: Up to 30 months
the number of response patients/the number of total patients
次要结局
未报告次要终点
研究者
He Huang
Professor
Zhejiang University
研究点 (1)
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