NCT03258047Unknown2 期
Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.
Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years, male or female;
- •Karnofsky≥60%；
- •B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
- •Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
- •Patients have had more than 2 combined chemotherapy regimens;
- •Creatinin <2.5mg/dL；ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL；
- •Proper venous condition for leukapheresis, no contraindication for leukapheresis;
- •Patient that could understand and is willing to sign the written consent;
- •Fertile female patient should be willing to take contraceptive measures.
- •Patient that is willing to follow up till at least 2 months after T cell re-transfusion.
排除标准
- •Patients who need ≥15mg prednisone daily due to any cause;
- •Patients with autoimmune disease and need immunosuppressor treatment;
- •Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
- •FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%；
- •Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%；
- •Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
- •Patients that have previously received gene therapy of any kind;
- •Obvious clinical encephalopathy or novel neuron function damage;
- •Patients with active infection;
- •Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
- •Patients who had allergic history to agents of the similar structure as CAR-T;
研究组 & 干预措施
CAR-T treatment
Experimental
In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
干预措施: CAR-T (Combination Product)
结局指标
主要结局
complete remission rate
时间窗: every 3 months until 20 months after the last patient's enrollment
complete remission rate after treated by CAR-T therapy
次要结局
- adverse events(from the date of the start of treatment to 20 months after last patient's enrollment)
- progression free survival(from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment)
- duration of the modified T cells by CAR-T in the patients(from the date of re-transfusison to 20 months after last patient's enrollment)
- overall survival(20 months after the last patient's enrollment)
研究者
Wenbin Qian
Doctor
First Affiliated Hospital of Zhejiang University
研究点 (1)
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