NCT03030001Unknown1 期
PD-1 Antibody Expressing Chimeric Antigen Receptor T Cells for Mesothelin Positive Advanced Malignancies
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety of infusion of autologous mesothelin specific CAR T cells
研究概览
简要总结
This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or refractory malignant tumors.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory advanced solid malignancies.
- •Progressive disease and no response to current therapy.
- •Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred. And patients are willing to attend the clinical trial.
- •Gender unlimited, age from 18 years to 80 years.
- •Life expectancy≥6 months.
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0-
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis ; Peripheral venous access ；no contraindication of lymphocyte separation.
- •IHC( immuno-histochemistry) result of tumor tissue： mesothelin positive for ：frequency≥2，intensity≥2 +. The percentage of tumor cell nuclei stained (0, no staining; 1, ≤10%; 2, 10-50% and 3, >50%) and the staining intensity (ranging from 0 to 3+).
- •Adequate hepatic function, renal function and bone marrow function：WBC≥3.0×109/L,PLT≥60×109/L,HGB≥85g/L,LY≥0.7×109/L; Alanine aminotransferase/Aspartate transaminase(ALT/AST) 2.5 times the upper limit of the normal value, total bilirubin(TBiL) 1times the upper limit of the normal value, Serum creatinine1.5 times the upper limit of the normal value.
- •Willing and able to understand and sign the Informed Consent Document.
- •Women of child-bearing age must have evidence of negative pregnancy test. Patients must be willing to practice birth control during and for four months following treatment.
排除标准
- •Life expectancy6 months.
- •Patients with uncontrolled active infection will be excluded.
- •Patients with severe heart and lung dysfunction; uncontrolled hypertension, unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded; aberrant pulmonary function testing: with a forced expiratory volume (FEV) of <30%(predicted), diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) <30% and oxyhemoglobin saturation90% will be excluded.
- •Patients with severe liver and kidney dysfunction or chronic diseases of important organs will be excluded.
- •Patients with active autoimmune disease requiring immunosuppressive therapy will be excluded.
- •Patients requiring corticosteroids (other than inhaled) will be excluded.
- •Patients with other severe diseases or situations improper for the research will be excluded, including neurologic disease, mental disease, immune disease, metabolic disease, and contagious disease.
- •Pregnant and/or lactating women will be excluded.
- •Patients who have had other bio-therapy in the past 4 weeks.
- •Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
- •Patients with the subject suffering disease affects the understanding of informed consent or complying with study protocol will be excluded.
结局指标
主要结局
Safety of infusion of autologous mesothelin specific CAR T cells
时间窗: 2 years
Safety of infusion of autologous mesothelin specific CAR T cells with PD-1 antibody expressing in patients with relapsed or refractory advanced solid malignancies using the NCI CTCAE V4.0 criteria
次要结局
- the response evaluation criteria of solid tumor(2 years)
- progression free survival(1 year)
- overall survival(2 years)
研究者
研究点 (1)
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