A Single-Arm, Single-Center, Open-Label Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Autologous Tumor-Reactive T Cells(GK02) Derived From Malignant Ascites Caused by Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of AEs
研究概览
简要总结
A single-arm, single-center, open-label clinical study comprising three cohorts, evaluating the safety, preliminary efficacy, and pharmacokinetic/ pharmacodynamic (PK/PD) characteristics of autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors.
The trial initially plans to enroll 9 subjects with malignant ascites caused by advanced solid tumors.
详细描述
To evaluate the safety and preliminary efficacy of an investigational cell therapy, Autologous Tumor-reactive T Cells (GK02) derived from malignant ascites caused by advanced solid tumors.
Following intraperitoneal infusion of GK02, the safety and tolerability of the subjects will be observed, the preliminary effectiveness of the investigational product GK02 in treating malignant ascites will be evaluated, and the pharmacokinetic/pharmacodynamic (PK/PD) characteristics post-administration will be exploratively assessed.
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
- •Ability to understand and sign a written informed consent document；
- •At the date of signing ICF, 18 ~75 years old, male or female；
- •Patients with advanced solid tumors confirmed by histology or pathology to have failed at least second-line treatment (treatment failure is defined as progression after treatment or intolerance after treatment), including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, ovarian cancer, etc.；
- •Pathological diagnosis or clinical diagnosis of malignant ascites, and the researcher determines that treatment for malignant ascites is necessary; During screening, the ascites volume was confirmed to be above the medium level by ultrasound (the maximum depth of ascites in the supine position was ≥3.0cm, and the total volume was ≥500ml);
- •ECOG 0-2 points;
- •Adequate organ functions;
- •There are no absolute or relative contraindications for puncture；
- •No peritoneal treatment for malignant ascites has been carried out within 14 days prior to the collection of malignant ascites;
- •Female of childbearing age who have a negative urine pregnancy test during the screening period and agree to take effective contraceptive measures for at least 6 months after perfusion; Male subjects whose partners are fertile must agree to use effective contraceptive methods and avoid sperm donation for at least six months after perfusion.
排除标准
- •Those with a history of severe allergies or allergic reactions to any components of the drugs to be used in this study, including but not limited to NMA-LD drugs, contrast agents and contrast agents used in imaging examinations, excipients such as dimethyl sulfoxide (DMSO) and antibiotics in cell products;
- •Central nervous system (CNS) metastasis is present;
- •Toxicity from previous antitumor therapy did not return to grade 1 or baseline levels (CTCAE version 5.0);
- •Accompanied or prior to interstitial lung disease or interstitial pneumonia;
- •Uncontrolled metabolic disorders, such as those in patients with diabetes (glycated hemoglobin ≥8.5%), or secondary reactions to other non-malignant organ or systemic diseases or cancer, which can lead to higher medical risks and/or uncertainties in survival assessment;
- •An autoimmune disease that is active or has previously suffered from and is likely to recur;
- •Uncontrolled comorbidities include but are not limited to uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) or any unstable cardiovascular and cerebrovascular diseases that occurred within 6 months prior to treatment enrollment;
- •Ultrasound indicates the separation of peritoneal effusion;
- •Patients with intestinal obstruction;
- •Patients with comorbidities or active autoimmune diseases that require the use of glucocorticoids or other immunosuppressive drugs during the trial period, excluding local transdermal absorption of glucocorticoids (i.e., no more than 5mg/ day of prednisone or equivalent doses of other glucocorticoids);
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
Tumor-reactive T cells-GK02
Treatment with autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors.
干预措施: GK02 (Drug)
结局指标
主要结局
Incidence of AEs
时间窗: 12 months
Incidence and severity of AEs, including but not limited to vital signs, physical examination, laboratory tests. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.
Incidence of DLTs
时间窗: 28 days
Number of DLTs (dose limiting toxicities) during the first 28 days after the administrations of GK02 in each cohort.
次要结局
- Changes in the volume of malignant ascites(12 months)
- PuFS(12 months)
- OS(12 months)