NCT05149391已完成1 期
A Phase 1 Study of CD19 and CD20 Targeted Chimeric Antigen Receptor T Cells Therapy (C-CAR039) in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma
Peking University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年7月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety Observation
研究概览
简要总结
This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B cell Non-Hodgkin's Lymphoma patients.
详细描述
The study includes the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepletion, C-CAR039 infusion, Dose-limiting toxicity observation and Follow-up Visit.
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
- •The patient volunteered to participate in the study and signed the Informed Consent;
- •Age, 18-70 years (include 18 and 70), male or female;
- •Expected survival ≥ 12 weeks
- •Eastern Cooperative Oncology Group score 0-2
- •CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria;
- •Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin's lymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and Mantle Cell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:
- •Diffuse Large B Cell Lymphoma, Non Specifically
- •Primary Mediastinal B-cell Lymphoma
- •Transformed Follicular Lymphoma
- •High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6
- •High Grade B-Cell Lymphoma, Non Specifically
- •For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded;
- •No contraindications of apheresis.
- •At least one measurable lesion according to Lugano 2014 criteria;
- •Adequate organ function and adequate bone marrow reserve
- •Hemoglobin≥80 g/L
- •Absolute neutrophil count≥1.0×109/L
- •Platelet≥50×109/L,
- •Creatinine≤1.5×upper limit of the normal range (ULN)
- •Cardiac ejection fraction≥50%
- •Saturation of Pulse Oxygen>92%
- •Total bilirubin≤1.5×ULN
- •Alanine Aminotransferase/Aspartate Aminotransferase≤3×ULN
排除标准
- •Malignant tumors other than B-Non-Hodgkin's lymphoma within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
- •Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus or treponema pallidum infection ;
- •Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need treatment;
- •Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion;
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
- •Patients who have been previously infected with tuberculosis;
- •Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039;
- •Patients with central nervous system involvement;
研究组 & 干预措施
C-CAR039
Experimental
Autologous C-CAR039 administered by intravenous (IV) infusion
干预措施: CD19/CD20-directed Chimeric Antigen Receptor T Cells (Biological)
结局指标
主要结局
Safety Observation
时间窗: up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.
Incidence of adverse events after C-CAR039 infusion. Incidence and severity of adverse events according to NCI-CTCAE v5.0 criteria, including Dose Limited Toxicity
次要结局
- Duration of response (DOR)(up to 24 months)
- Maximum concentration (Cmax) of C-CAR039 in the peripheral blood.(Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24)
- Time to maximum concentration (Tmax) of C-CAR039 in the peripheral blood.(Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24)
- Peripheral blood duration of C-CAR039 in the peripheral blood after infusion.(Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24)
- Area under the curve 0h-28d of C-CAR039 in the peripheral blood.(Baseline, Days 4, 7, 10 and weeks 2, 3, 4)
- Progression-free survival (PFS)(4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months)
- Overall response rate (ORR)(4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months)
- Overall survival (OS)(up to 24 months)
研究者
Jun Zhu
Professor
Peking University Cancer Hospital & Institute
研究点 (1)
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