A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours

Grit Biotechnology3 个研究点分布在 1 个国家目标入组 18 人2024年4月18日

适应症Solid Tumor, Adult

干预措施GT307 injection

概览

阶段: 不适用
干预措施: GT307 injection
疾病 / 适应症: Solid Tumor, Adult
发起方: Grit Biotechnology
入组人数: 18
试验地点: 3
主要终点: Incidence and severity of adcersed events per CTCAE 5.0
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).

注册库

clinicaltrials.gov

开始日期

2024年4月18日

结束日期

2027年4月18日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Grit Biotechnology

责任方

Sponsor

入排标准

入选标准

•1\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to comply with the study protocol.
•2\. Aged 18-70 years old (eligibility for subjects over 70 years old shall be jointly determined by the investigator and the medical monitor of the collaborating party).
•3\. Diagnosed as patients with advanced solid tumors who have failed standard treatment, have no available standard treatment, or are unable to receive standard treatment.
•4\. Having at least one lesion that is untreated with radiotherapy or other local therapies, with accessible tumor tissue (assessed by the investigator), and from which a tissue block of ≥1.0 cm³ can be isolated after resection (either from a single lesion or a combination of multiple lesions) for the preparation of autologous tumor-infiltrating lymphocytes (TILs); minimally invasive procedures should be used whenever possible.
•5\. After tumor sampling, having at least one measurable lesion as defined by the RECIST v1.1 criteria, and the lesion must not have received radiotherapy or other local therapies (unless such therapies were administered more than 3 months prior and the lesion has demonstrated progression).
•6\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
•7\. Expected survival time of ≥12 weeks.
•8\. Adequate function of major organs meeting the following requirements:
•Hematological parameters: Since the normal reference ranges may vary among different central laboratories, the final assessment shall be made by the investigator based on comprehensive judgment, with the following references:
•Absolute Neutrophil Count (ANC) ≥1.0×10⁹/L;

排除标准

•Subjects with spinal cord compression that cannot be relieved by surgery and/or radiotherapy are not eligible for enrollment.
•(For treated subjects, enrollment is permitted if clinical evidence demonstrates that symptoms have been relieved for ≥1 week prior to surgical sampling.)
•2\. Subjects with uncontrolled tumor-related pain as assessed by the investigator. Subjects requiring analgesic treatment must be on a stable analgesic regimen at the time of study entry. Symptomatic lesions suitable for palliative radiotherapy must be treated before study entry.
•3\. A history of bleeding events occurring within 3 months prior to screening, including but not limited to gastrointestinal bleeding caused by fundic or esophageal varices, increased bleeding risk due to portal hypertension, active gastrointestinal bleeding, etc.; or subjects assessed by the investigator as having a high risk of major bleeding (examples include but are not limited to tumors encasing or invading major blood vessels \[i.e., carotid artery, jugular vein, bronchial artery\] and/or exhibiting other high-risk features such as fistulas, significant cavitary lesions, a history of prior bleeding \[≤60 days from signing the ICF\]).
•4\. A history of arterial/venous thrombotic events occurring within 3 months prior to screening, including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, etc.
•5\. A diagnosis of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory system diseases that severely impair pulmonary function.
•6\. A history of clinically significant cardiovascular diseases, including but not limited to:
•Congestive heart failure (NYHA classification \> Class 2);
•Unstable angina pectoris;
•Myocardial infarction occurring within the past 3 months;

研究组 & 干预措施

GT307 injection treatment group

干预措施: GT307 injection

结局指标

主要结局

Incidence and severity of adcersed events per CTCAE 5.0

时间窗: 3 years

To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0