ong-Term Follow-Up (LTFU) of Participants Treated with Adoptive Cell Therapies - 208750/04

Adaptimmune LLC0 个研究点目标入组 76 人开始时间: 2024年6月12日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Adaptimmune LLC
入组人数: 76

研究概览入排标准研究者记录与标识符相似试验

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: 0 至 65+（—）
性别: All

入选标准

•Type of Participant and Disease Characteristics 1. Participants who: a. Have received at least one infusion of an Adaptimmune adoptive cell therapy agent and b. Have completed an Adaptimmune sponsored or supported interventional study or have withdrawn from it, as defined by the interventional protocol or c. have completed treatment as part of managed access to an adoptive cell therapy, Participants who complete an interventional study will complete the assessments outlined in the interventional protocol prior to starting on this study., Sex 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 cell therapy infusion, or until the participants' persistence of gene modified cells is below the level of detection for 2 consecutive assessments, 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 OR - Must agree to use contraception/barrier as detailed below · 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 · Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person, 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 OR - 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 until the participants' persistence of gene modified cells is below the level of detection for 2 consecutive assessments, 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. - 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, Informed Consent. Capable o

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研究者

发起方

Adaptimmune LLC

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