NCT06145802撤回不适用
Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of Advanced Solid Tumors (Gynecological Tumors)
Grit Biotechnology1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年3月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidience and severity of adverse events per CTCAE 5.0
研究概览
简要总结
This study is a single-arm, open clinical trial.This trial consists of two phases, dose-escalation and expansion, and the study process is divided into: a screening period, a sampling and production period, a NMA-LD chemotherapy period, a treatment and observation period, and a follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
- •2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
- •3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues ≥1.0cm^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
排除标准
- •1. Subjects with ≥3 untreated CNS metastases at screening (If the subject has ≤3 CNS metastases with a maximum diameter of <1cm, and there is no peritumor edema on brain imaging (MRI or CT).no evidence of progressive CNS disease on brain imaging at least 3 months after treatment, then subjects will be included.);
- •2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);
- •3. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring
- •4. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis,pericardial effusion, active gastrointestinal bleeding or IL-2 contraindications;
- •5. Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same
- •6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
- •7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
研究组 & 干预措施
GT316 treatment group
Experimental
干预措施: GT316 (Biological)
结局指标
主要结局
Incidience and severity of adverse events per CTCAE 5.0
时间窗: 3 years
To characterize the safety profile of autologous TIL injection (GT316) in patients with relapsed/metastatic advanced solid tumor as measured by incidience and severity of adverse events per CTCAE 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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