NCT07475182招募中1 期
Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Patients With Advanced Solid Cancers.
Hainan Cancer Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年12月6日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Targeted Activated DC combined with CAR-T therapy in patients with Advanced Solid Cancers.This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
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
- •Age ≥ 18 years and ≤ 75 years, regardless of gender;
- •Advanced solid tumors with clear pathological confirmation, including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, etc.; at least one measurable lesion meeting RECIST 1.1 criteria (according to RECIST 1.1, the longest diameter of a measurable lesion on spiral CT scan ≥ 10 mm, or the short diameter of a pathological lymph node ≥ 15 mm);
- •Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+; percentage of positive cells ≥ 40%);
- •Meets the indications for PBMC collection and has no contraindications for cell collection;
- •Failure of standard second-line treatment, or lack of a standard treatment regimen; or refusal to receive chemotherapy (with signed documentation);
- •ECOG performance status: 0-1;
- •Life expectancy: ≥ 3 months;
- •Toxicities from prior chemotherapy or other anti-tumor therapies must have resolved after a washout period (except for residual alopecia), ensuring that all organ functions meet the inclusion criteria;
- •Adequate organ function, including:
- •Adequate immune function: absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L.
- •Adequate hematopoietic function: platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L. Patients must not have received blood transfusions or treatments such as granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin within 14 days prior to the blood count assessment.
- •Adequate liver function: total bilirubin (TBIL) < 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN.
- •Adequate renal function: creatinine (Cr) ≤ 1.5 × ULN.
- •Adequate coagulation function: prothrombin time (PT) or activated partial thromboplastin time (APTT) < 1.5 × ULN, and international normalized ratio (INR) < 1.
- •Individuals of childbearing potential must agree to use effective contraception during the study;
- •Ability to understand and willingness to sign a written informed consent form;
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression;
- •Significant cardiovascular disease, including:
- •Documented major cardiovascular events within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or prior angioplasty, stent implantation, or coronary artery bypass grafting;
- •Clinically significant QT interval prolongation (QTcF > 470 ms for women or QTcF > 450 ms for men);
- •Clinically significant bleeding tendency or coagulation disorders (e.g., hemophilia);
- •Active infection with HIV, syphilis, hepatitis B virus (HBV), or hepatitis C virus (HCV);
- •History of involuntary commitment due to mental illness, or any psychiatric condition deemed by the investigator to make the patient unsuitable for the trial;
- •Concurrent autoimmune diseases, or long-term use of immunosuppressants or systemic corticosteroids;
- •Poor compliance, as assessed by the investigator;
- •Prior treatment with any targeted CAR-T cell therapy within 3 months before this CAR-T infusion;
- •Uncontrolled active bacterial or fungal infections;
- •Any other condition that, in the opinion of the investigator, makes the patient ineligible for the study.
研究组 & 干预措施
Targeted Activated Dendritic Cells
Experimental
干预措施: Targeted Activated Dendritic Cells (Biological)
Targeted Activated Dendritic Cells
Experimental
干预措施: Targeted CAR-T Cells (Biological)
结局指标
主要结局
Adverse Events (AEs)
时间窗: 2 years post cell infusion
To evaluate adverse events following infusion of targeted activated dendritic cells (DC) and CAR-T cells, with an assessment of the incidence and severity of treatment-related toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
次要结局
- Objective Response Rate (ORR)(2 years)
- Disease Control Rate (DCR)(2 years)
- Progression-free survival (PFS)(2 years)
- Changes in the Immune Microenvironment(1 month post cell infusion)
研究者
研究点 (1)
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