A Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.
详细描述
For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 70 years at screening
- •Voluntary participation and able to sign the informed consent form
- •Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment.
- •Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes
- •At least one measurable target lesion (per RECIST v1.1)
- •ECOG performance status score: 0~1
- •Expected survival ≥ 3 months
- •Negative serum or urine pregnancy test results for females of child-bearing age at screening
排除标准
- •Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease)
- •Symptomic chronic obstructive pulmonary disease or persistent asthma
- •Uncontrolled cardiovascular diseases
- •History of primary immune deficiency, autoimmune disease or chronic inflammatory disease
- •High-risk subjects with rapid tumor progression as judged by the Investigator(s)
- •Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS
- •History of organ transplantation or allogeneic cell therapy
- •Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results
结局指标
主要结局
Adverse Events (AE)
时间窗: up to 12 months or through study completion
To characterize the safety profile and evaluate tolerability of C-TIL052A cell therapy by collecting, analyzing the treatment emergent adverse events (TEAEs) and adverse events of special interest (AESIs) during and post treatment, especially the incidence and severity of adverse events (AE) within 28 days post TIL infusion.
次要结局
- Overall Survival（OS）(up to 12 months or through study completion)
- Disease Control Rate (DCR)(up to 12 months or through study completion)
- Duration of Response (DOR)(up to 12 months or through study completion)
- Time to Response (TTR)(up to 12 months or through study completion)
- Objective Response Rate (ORR)(up to 12 months or through study completion)
- Progression Free Survival（PFS）(up to 12 months or through study completion)