Exploratory Clinical Study of Tumor-Specific Cytotoxic T Lymphocyte Injection (cCTL) in Combination With Immunotherapy for Advanced Gynecologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study is a single-arm, open-label, interventional, and exploratory clinical trial,the goal of which is to evaluate the safety and clinical efficacy of the novel tumor-specific cytotoxic T lymphocyte (cCTL) injection in combination with immunotherapy for the treatment of advanced gynecologic malignancies.The trial will also explore the preliminary efficacy and immunological characteristics of this therapy in a small sample of patients. 5-20 participants will be enrolled.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years；
- •Histologically or cytologically confirmed diagnosis of advanced ovarian cancer, cervical cancer, endometrial cancer, or other gynecological malignancies;
- •Tumor patients with previous standard treatment failure, or those who refuse further chemotherapy, with a life expectancy of more than 3 months;
- •ECOG performance status of 0-2;
- •Patients of childbearing potential must use appropriate contraceptive methods (e.g., contraception or other methods of fertility control) before and during the trial;
- •Ability to understand the trial and have signed the informed consent form;
- •Ability to comply with the study protocol and follow-up procedures.
排除标准
- •Receipt of any form of immunotherapy within the past 3 months;
- •Required use of immunosuppressive agents;
- •Receipt of tumor chemotherapy, radiotherapy, or second-degree or higher surgery within the past month;
- •History of other cancers, except for in situ cervical cancer, treated squamous cell carcinoma, or bladder epithelial tumors (Ta and TIS), or other malignancies that have undergone radical treatment (at least 5 years prior to enrollment);
- •White blood cell count < 3×10^9/L, platelet count < 80×10^9/L;
- •AST and ALT > 3× upper limit of normal (ULN), total bilirubin > 2× ULN, for liver metastasis patients, AST and ALT > 6× ULN;
- •Creatinine clearance < 60 ml/min;
- •Coagulation dysfunction;
- •Active bacterial or fungal infections (≥ grade 2 of NCI-CTC, 3rd edition);
- •Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA > 100 IU/mL; positive for hepatitis C antibody with peripheral blood HCV RNA positive; positive for HIV antibody; positive CMV DNA; positive for syphilis;
- •Diseases deemed inappropriate for enrollment by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring drug treatment, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease;
- •Meeting any of the following heart-related standards:
- •Screening heart ultrasound shows left ventricular ejection fraction (LVEF) < 50%;
- •Screening ECG at rest shows QTcF > 480 ms (female);
- •Resting ECG shows any significant clinical arrhythmia, conduction, or morphological abnormalities (e.g., complete left bundle branch block, 2nd-3rd degree atrioventricular block, PR interval > 250 ms);
- •Presence of factors increasing the risk of QTc interval prolongation or arrhythmic events, such as heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, family history of long QT syndrome, or known medications that prolong QT intervals;
- •Pregnant or breastfeeding women; women of childbearing potential must test negative for pregnancy within 7 days prior to enrollment;
- •Drug abuse, clinical, psychological, or social factors that impair informed consent or study implementation；
- •Known allergy to the study drug;
- •Participation in other clinical trials within 1 month before enrollment;
- •Inability to undergo apheresis or inability to establish peripheral venous access;
- •Any uncertain factor that may affect the safety or compliance of the patient;
- •Other conditions considered unsuitable for enrollment by the investigator.
研究组 & 干预措施
cCTL experimental group
The planned treatment duration for each patient in the clinical trial is 2-4 months, with one cycle lasting 1 month. Each cycle will include multiple intravenous infusions of cCTL (generally 4-10 times), with treatment frequency ranging from one to three times per week (based on individual patient conditions, as determined by the investigator). The dose for each infusion is 2-5x10^7 cCTL cells per kg of body weight.
干预措施: cCTL treatment (Biological)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From enrollment to the end of treatment at 8 weeks
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). ORR was defined as the percentage of participants who had a Complete Response (Disappearance of all target lesions) or a Partial Response (≥30% decrease in the sum of the longest diameter of target lesions) using RECIST 1.1 based on BICR.
次要结局
未报告次要终点