NCT07479667招募中1 期
An Exploratory, Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Antibody-armored Dendritic Cell Injection Following a Single Administration in Patients With Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This study is a single-arm, open-label, single-administration dose-escalation study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;
- •ECOG performance status score of 0 to 1;
- •Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;
- •Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;
- •Positive expression for at least one of TERT, P53, KRAS and Survivin;
- •Sufficient venous access with no contraindications to peripheral blood mononuclear cell collection;
- •Adequate organ and bone marrow function:
- •a) Platelet count ≥ 90×10⁹/L;
- •b) Hemoglobin ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
- •c) Mononuclear cell count ≥ 1.0×10⁹/L;
- •d) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN);
- •e) Serum creatinine ≤ 1.5 × upper limit of normal (ULN);
- •f) Aminotransferases (AST, ALT) ≤ 2.5 × upper limit of normal (ULN);
- •g) Total bilirubin ≤ 2 × upper limit of normal (ULN);
- •h) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as assessed by echocardiography within 1 month prior to enrollment;
- •Able to understand the study requirements and considerations and provide informed consent to participate in the clinical study in accordance with the study requirements
- •Subjects agree to use effective contraceptive measures for at least 6 months following dendritic cell (DC) injection.
排除标准
- •Women who are pregnant or breastfeeding;
- •Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies/mL; or hepatitis C virus (HCV) RNA copy number above the LLOD;
- •Prior treatment with any dendritic cell (DC) or other immune cell therapy;
- •History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;
- •Uncontrolled active infection;
- •Subjects with active autoimmune disease receiving relevant treatment; subjects with organ transplantation who are still on immunosuppressive agents; or subjects requiring long-term use of immunosuppressive agents (> 15 mg/day prednisone or equivalent glucocorticoid dose) and who have used them within 4 weeks prior to screening;
- •Presence of central nervous system (CNS) metastases and clinically significant CNS diseases;
- •Received systemic anti-tumor therapy within 4 weeks prior to screening;
- •Presence of residual lesions or unremoved foci on screening examinations (post-adjuvant chemotherapy / post-surgery), with imaging indicating local recurrence or confirmed distant metastasis;
- •History of other active malignancies within 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);
- •Clinically significant major cardiovascular diseases including:
- •a) Symptomatic congestive heart failure
- •b) Unstable angina pectoris
- •c) Severe arrhythmia requiring pharmacotherapy
- •d) Uncontrolled hypertension
- •e) Myocardial infarction or ventricular arrhythmia within 6 months prior to screening;
- •Any other conditions deemed by the investigator to render the subject ineligible for participation in the clinical study
研究组 & 干预措施
Armored Dendritic Cell Injection
Experimental
干预措施: Armored Dendritic Cell Injection (Biological)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Day 0-Month 5
Evaluate the incidence and severity of adverse events
时间窗: Day 0-Month 24
Adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities (including their types, frequencies and severity) will be collected. This includes the types, incidence and severity of adverse events, as well as clinically significant abnormal laboratory test results and abnormal physical examination findings that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using Version 6.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). The causal relationship between adverse events and the dendritic cell (DC) product will be assessed by investigators in accordance with the causality evaluation criteria specified in the study protocol.
次要结局
- concentration of tumor markers(day 0-month 5)
- Cmax(day 0-day28)
- antigen-specific T-cell responses(day 0-Month 5)
- RFS(day 0-Month 24)
- Tmax(day 0- day 28)
- Tlast(day 0-day 28)
研究者
研究点 (1)
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