NCT04317885已完成1 期
A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Relapsed or Refractory NHL Subjects
Shanghai Tongji Hospital, Tongji University School of Medicine1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年11月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR039 in treatment of relapsed or refractory NHL patients
详细描述
This study plans to enroll 25 patients to assess the safety and efficacy of C-CAR039. Subjects who meet the eligibility criteria will receive a single dose of C-CAR039 injection.
The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Bridging (if needed), Baseline, lymphodepletion, C-CAR039 infusion, 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 75 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 18-75 years old, male or female
- •CD19 or CD20 positive DLBCL (including PMBCL and tFL), FL and MCL confirmed by cytology or histology according to WHO2016 criteria. 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 should be recorded.
- •Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
- •At least one measurable lesion (LDi ≥ 1.5 cm);
- •At least two weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis;
- •LVEF≥ 50% (ECHO)
- •No active pulmonary infections, normal or mild impaired pulmonary function and SpO2≥92%
- •Laboratory criteria: ANC≥1.0×109/L; Platelets≥50×109/L; Serum total bilirubin ≤1.5x ULN; Creatinine≤ ULN; AST and ALT≤3x ULN
- •No contraindications of apheresis;
- •Expected survival ≥ 3months
- •ECOG score 0 or 1
排除标准
- •Have a history of allergy to cellular products;
- •According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
- •A history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
- •Patients with central nervous system involvement;
- •Patients with autoimmune diseases, immunodeficiency or other conditions requiring immunosuppressive therapy;
- •Received allogeneic hematopoietic stem cell transplantation before;
- •Previous use of any CAR T cell product or other genetically modified T cell therapy;
- •Autologous stem cell transplantation within 6 weeks before infusion;
- •Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;
- •Live vaccination within 4 weeks prior to apheresis;
- •People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
- •A history of alcohol abuse, drug use or mental illness;
- •Subjects who are not sterilized and have any of the following conditions:
- •are pregnant/lactating; or
- •planned pregnancy during the trial; or
- •being fertile and unable to use effective contraception;
- •Severe hypersensitivity to fludarabine or cyclophosphamide;
- •A history of other primary cancers other than the following:
- •Non-melanoma tumors such as basal cell carcinoma of the skin that are cured by excision
- •Cured in situ cancers such as cervical, bladder, or breast cancer
- •The investigators consider that the subject has other conditions that are not suitable for this trial.
研究组 & 干预措施
Prizloncabtagene Autoleucel
Experimental
Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion
干预措施: Prizloncabtagene Autoleucel (Biological)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Up to 12 weeks after C-CAR039 infusion
Incidence and severity of adverse events after CAR-T infusion
次要结局
- Progression-free survival (PFS)(Up to 24 Months after C-CAR039 infusion)
- Overall survival (OS)(Up to 24 Months after C-CAR039 infusion)
- Overall Response rate (ORR)(Up to 24 Months after C-CAR039 infusion)
- Duration of response (DOR)(Up to 24 Months after C-CAR039 infusion)
研究者
Aibin Liang，MD，Ph.D.
Director, Department of Hematology
Shanghai Tongji Hospital, Tongji University School of Medicine
研究点 (1)
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