NCT06006390招募中1 期
Chimeric Antigen Receptor T Lymphocytes (CAR-T) Targeting CEA in the Treatment of CEA Positive Clinical Study of Advanced Malignant Solid Tumors
Chongqing Precision Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]
研究概览
简要总结
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
详细描述
According to the different infusion methods, it is divided into two subgroups: intravenous infusion and local infusion through the peritoneal cavity. Each subgroup includes a dose exploration stage (Part A) and a dose expansion stage (Part B). 3 patients were explored, starting from the low-dose group, and in the dose expansion phase, the safety and efficacy were further verified according to the safe recommended dose obtained in the dose exploration phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 old, male or female;
- •Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;
- •After receiving at least second-line standard treatment failure (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;
- •Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug/L.
- •At least one assessable lesion according to RECIST 1.1 criteria;
- •ECOG score 0-2 points;
- •No serious mental disorder;
- •Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:
- •Blood routine: white blood cells>3.0×10^9/L, neutrophils>0.8×10^9/L, lymphocytes cells>0.5×10^9/L, platelets>75×10^9/L, hemoglobin>80g/L;
- •Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
- •Renal function: serum creatinine≤2.0×ULN;
- •Liver function: ALT and AST ≤3.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤5.0×ULN);
- •Total bilirubin≤3.0×ULN;
- •Oxygen saturation ≥95% in non-oxygen state.
- •Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
- •Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);
- •The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
排除标准
- •Those who have central nervous system metastasis or meningeal metastasis at the time of screening are judged by the investigator to be unsuitable for inclusion;
- •Participated in other clinical studies within 1 month before screening;
- •vaccinated with live attenuated vaccine within 4 weeks before screening;
- •Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
- •Active infection or uncontrollable infection requiring systemic treatment;
- •Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;
- •Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;
- •Suffering from any of the following heart diseases:
- •New York Heart Association (NYHA) stage III or IV congestive heart failure;
- •Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
- •Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);
- •History of severe non-ischemic cardiomyopathy;
- •Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;
- •Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin;
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer test is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
- •Women who are pregnant or breastfeeding;
- •Other investigators deem it unsuitable to participate in the research.
结局指标
主要结局
To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]
时间窗: 1 month
The incidence of adverse events after CEA CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies[Safety and Tolerability]
时间窗: 28 days
Dose-limiting toxicity after CEA CAR-T cell infusion
次要结局
- AUCS of CEA CAR-T cells [Cell dynamics](3 months)
- Assessing disease control rates of CAR-T cell preparations in CEA-positive advanced malignancies[Effectiveness](3 months)
- CMAX of CEA CAR-T cells [Cell dynamics](3 months)
- TMAX of CEA CAR-T cells[Cell dynamics](3 months)
- Pharmacodynamics of CEA CAR-T cells[Cell dynamics](3 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid TumorsGastric CancerColon CancerRectal CancerEsophageal CancerPancreatic CancerNCT05538195Chongqing Precision Biotech Co., Ltd17
招募中
1 期
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid TumorsRectal CancerColon CancerEsophagus CancerPancreas CancerLung CancerBreast CancerGastric CancerCholangiocarcinomaNCT06126406Chongqing Precision Biotech Co., Ltd60
进行中（未招募）
1 期
Claudin18.2 CAR-T (CT041) in Patients with Gastric, Pancreatic Cancer, or Other Specified Digestive CancersGastric CancerPancreatic CancerNCT04404595CARsgen Therapeutics Co., Ltd.110
进行中（未招募）
1 期
Duvelisib Following Chimeric Antigen Receptor T-Cell TherapyNon-hodgkin LymphomaAcute Lymphocytic LeukemiaNCT05044039Washington University School of Medicine42
进行中（未招募）
1 期
Clinical Trial to Evaluate Zevor-cel (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)Multiple MyelomaNCT03915184CARsgen Therapeutics Co., Ltd.105