EUCTR2018-004888-31-IT进行中（未招募）1 期
ong Term Follow-Up of Participants Exposed to GSK3377794 (NYESO- 1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor - PH1, Long Term Follow-up of Cancer Patients Exposed to NY-ESO-1c259 T
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 65 人开始时间: 2021年6月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Type of Participant and Disease Characteristics
- •1. Participants who:
- •a. Have received at least one dose of GSK3377794 in the interventional study and
- •b. Have either completed the interventional study or have withdrawn from it
- •Participants who complete the interventional study will complete the assessments
- •outlined in the interventional protocol prior to starting on this study.
- •2. Male or Female participants. Contraceptive use by men or women should be
- •consistent with local regulations regarding the methods of contraception for those
- •participating in clinical studies.
- •a. Male Participants:
- •Male participants are eligible to participate if they agree to the following contraception guidelines, starting at the first dose of chemotherapy and for at least 12 months after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/gene modified cells in the participant’s blood, whichever is longer. If participants have received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells.
- •- Refrain from donating sperm
- •PLUS either:
- •- Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •- Must agree to use contraception/barrier as detailed below
- •o Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
- •o Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person
- •b. Female Participants:
- •A female participant is eligible to participate if at least one of the following
- •conditions applies:
- •- Is not a woman of childbearing potential (WOCBP) as defined in Section 10.4.1 of the protocol
- •- Is a WOCBP (as defined in Section 10.4.1) who will agree to use a barrier method
- •(male condom) and use a contraceptive method that is highly effective (with a
- •failure rate of <1% per year), as described in Section 10.4.2 for at least 12 months
- •after receiving the T-cell infusion, or 4 months after there is no evidence of persistence/ gene modified cells in the participant’s blood, whichever is longer. If WOCBP participants have received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells. WOCBP should also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method.
- •- Additional requirements for pregnancy testing are located in Appendix 2
- •- The investigator is responsible for review of medical history, menstrual history,
- •and recent sexual activity to decrease the risk for inclusion in the interventional
- •study of a woman with an early undetected pregnancy
- •Informed Consent
- •3. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and
排除标准
- •Not applicable
研究者
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