NCT03299738Unknown1 期
A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-cell Non-Hodgkin Lymphoma (NHL)
Shanghai AbelZeta Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
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 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 (including PMBCL) or follicular lymphoma (grade Ⅲb) according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)
- •Progressive disease after the last standard chemotherapy regimens per the IWG Response Criteria (1999)
- •Stable disease after the last standard chemotherapy regimens (at least 4 cycles of first-line therapy or 2 cycles of later-line therapy) per the IWG Response Criteria (1999)
- •Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT)
- •Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
- •At least 2 combination chemotherapy regimens (excluding single agent monoclonal antibody)
- •Relapse or progressive disease within 1 year after last 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
- •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 ≥ 1.5 cm)
- •Expected survival ≥ 12 weeks
- •ECOG score 0-1
- •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, or at least 4 weeks from monoclonal antibody therapy prior to CAR T cell therapy
- •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
研究组 & 干预措施
C-CAR011
Experimental
Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene
干预措施: C-CAR011 (Biological)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 12 weeks
Safety: Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 12 weeks
Vital signs, physical examination, clinical laboratory tests, incidence of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Overall survival (OS)(12 months)
- Duration of remission (DOR)(12 months)
- Progression free survival (PFS)(12 months)
- Overall response rate (ORR)(12 months)
研究者
研究点 (1)
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