NCT03483688已完成1 期
A Phase Ⅰb Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- AE
研究概览
简要总结
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
详细描述
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteered to participate in this study and signed informed consent.
- •Age 18-70 years old, male or female.
- •Relapse or refractory B cell non-Hodgkin's lymphoma ,Histologically diagnosed as DLBCL,follicular lymphoma and Mantle cell lymphoma according to the NCCN. nonHodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)
- •DLBCL and Follicular Lymphoma (stage Ⅲ-Ⅳ, grade Ⅲb).
- •Progressive disease after the last standard chemotherapy regimens.
- •Stable disease after the last standard chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later-line therapy).
- •Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT).
- •Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
- •Relapse or progressive disease within 1 year after the last standard chemotherapy regimens(At least 2 combination chemotherapy regimens).
- •Stable disease after the last standard chemotherapy regimens(at least 2 cycles of combination chemotherapy regimens).
- •Mantle cell lymphoma
- •Relapse after 1st CR or persistent disease, and not eligible or appropriate for SCT.
- •Relapse or progressive disease within 1 year after the last chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later- line therapy).
- •Relapse or progressive disease within 12 months after autologous SCT.
- •All subjects must have received anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline-containing chemotherapy regimens according to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1).
- •At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5cm).
- •Expected survival ≥ 12 weeks.
- •ECOG score 0-
- •Left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography).
- •No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
- •At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy) prior to leukapheresis.
- •No contraindications of leukapheresis.
- •Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial.
排除标准
- •History of allergy to cellular products.
- •Laboratory tests: absolute neutrophil count < 1.0 × 10^9 /L, platelet count < 50×10^9 /L, serum albumin < 30 g/L,serum bilirubin > 1.5 ULN, serum creatinine > ULN, ALT/AST > 3 ULN.
- •History of CAR T cell therapy or any other genetically modified T cell therapy.
- •Relapse after allogeneic hematopoietic stem cell transplantation.
- •Active infections that require treatment (uncomplicated urinary tract infections and bacterial pharyngitis are allowed), prophylactic antibiotic, antiviral and antifungal treatment are permitted.
- •Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired or congenital immune deficiency diseases, including but not limited to HIV infection.
- •Class III or IV heart failure according to the NYHA Heart Failure Classifications.
- •QT interval prolongation ≥ 450 ms.
- •History of epilepsy or other central nervous system disorders.
- •Evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging.
- •History of other primary cancers, with the following exceptions.
- •Excisional non-melanoma (e.g. cutaneous basal cell carcinoma).
- •Cured in situ carcinoma (e.g. cervical cancer, bladder cancer, breast cancer).
- •Autoimmune diseases that require treatment, immune deficiency diseases or other diseases that require immunosuppressive therapy.
- •Used of systemic steroids within two weeks (using inhaled steroids is an exception).
- •Women who are pregnant or lactating, or who have breeding intent in 6 months.
- •Participated in any other clinical trial within three months.
- •Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.
结局指标
主要结局
AE
时间窗: 12 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Progression free survival (PFS)(12 months)
- Overall response rate (ORR)(12 months)
- Duration of remission (DOR)(12 months)
- Overall survival rate（OSR）(12 months)
研究者
研究点 (1)
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