IRCT20140818018842N34尚未招募1 期
Investigating the safety and efficacy of cell therapy with Tumor-Infiltrating Lymphocytes (TILs) in the Triple Negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- Female
入选标准
- •Ability to understand the requirements of the study. Specifically, the patient has to provide written informed consent
- •All patients must have triple-negative breast cancer as defined by the 2018 ASCO guidelines.
- •Patients must have at least one resectable lesion of a minimum of 1.5 cm in diameter post-resection for TILs investigational production.
- •Patients must be = 18 years of age at the time of consent.
- •The patients of childbearing potential must be willing to practice an approved method of birth control during treatment and 12 months after receiving all protocol-related therapy.
- •Patients must have adequate bone marrow function
- •Patients must have adequate organ function:
- •Patients must be seronegative for the human immunodeficiency virus (HIV1 and HIV2).
- •Patients must have recovered from all prior anticancer treatment-related adverse events.
- •Patients must have provided written authorization to use and disclose protected health information.
- •Patients must be able and willing to comply with the study visit schedule and protocol requirements, including long-term follow-up (LTFU).
排除标准
- •Participation in other clinical trials
- •Patients who have received a vaccine over the past 6 months.
- •Patients with immune deficiencies
- •Patients undergoing systemic steroidal treated
- •Patients who have a history of any cell therapy in the last six months
- •Patients with a severe active infection
研究者
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