NCT06088472进行中（未招募）1 期
A Single-arm Phase I Clinical Study of TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Grit Biotechnology2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年4月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events per CTCAE 5.0
研究概览
简要总结
This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
- •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, and at least tissue blocks with a volume of≥0.5 cubic centimeter (either of single lesion origin or multiple lesions combined) can be isolated for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
排除标准
- •1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
- •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) within 14 days before lymphocyte depletion chemotherapy;
- •3. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
- •4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;
- •5. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
- •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
TIL injection treatment group
Experimental
干预措施: TIL injection (Biological)
结局指标
主要结局
Incidence and severity of adverse events per CTCAE 5.0
时间窗: From TIL infusion to the 24th week
To characterize the safety profile of autologous TIL injection (GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
次要结局
- Objective response rate (ORR)(Up to 24 months post infusion)
- Disease control rate (DCR)(Up to 24 months post infusion)
- Progression-free survival (PFS)(Up to 24 months post infusion)
- Duration of Response (DoR)(Up to 24 months post infusion)
- Overall survival (OS)(From the date of TIL infusion to date of death due to any cause, or up to 24 months post infusion (whichever occurs first))
研究者
研究点 (2)
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