NCT04287309Unknown不适用
CAR-T Cellular Therapy for B Cell Malignancies Involved in Central Nervous System
Zhejiang University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse events that related to treatment
研究概览
简要总结
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary objective is to explore the safety. The secondary objective is to explore the efficacy.
详细描述
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. All together 20 patients were enrolled. Primary objective is to explore the safety including the complication of cytokine release syndrome, CRES, pancytopenia and infection. The secondary objective is to explore the efficacy. We will also detect CAR-T cell expansion dynamics in blood and cerebral fluid and compare the difference.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Male or female aged ≥ 3 and <70 years old; 2.Histologically confirmed diagnosis of CD19+ B cell malignancies involved in CNS 3.Relapsed or refractory CD19+ B cell malignancies 4.total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L; 5.Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; 6.No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%; 7.Estimated survival time ≥ 3 months; 8.ECOG performance status 0 to 2; 8.Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
排除标准
- •Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;
- •extensive involvement of gastrointestinal lymphoma;
- •radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
- •Have a history of allergy to any of the components in the cell products;
- •According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;
- •Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;
- •Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).
- •Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;
- •History of other primary cancer, except for the following conditions:
- •Cured non-melanoma after resection, such as basal cell carcinoma of the skin;
- •Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;
- •Patients with graft-versus-host disease (GVHD);
- •19.Prior immunizations with live vaccine 4 weeks prior to screening; 13.History of alcoholism, drug abuse or mental illness; 14.Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids; 15.Patients who have participated in any other clinical studies within 2 weeks prior to screening; 16.pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender); 17.Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
结局指标
主要结局
Adverse events that related to treatment
时间窗: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
次要结局
- The response rate of CAR-T treatment in patients with relapse/refractory B cell malignancies involved in CNS that treated by CD19 CAR-T cells therapy(6 months)
研究者
He Huang
Professor
Zhejiang University
研究点 (2)
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