ow-dose interleukin-2 for Treg expansion after induction therapies in multiple sclerosis (LITMUS)

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 14 人开始时间: 2022年10月31日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•1. Able to provide informed consent
•2. Definite diagnosis of relapsing-remitting multiple sclerosis
•3. Treated with alemtuzumab or cladribine within a specified period before recruitment

•1. Concurrent treatment with Copaxone, beta interferon, dimethyl fumarate, teriflunomide, fingolimod, natalizumab or ocrelizumab
•2. Concurrent use of any other immunosuppressant or cytotoxic therapy
•3. Oral/IV high-dose steroid use within 4 weeks of recruitment to the study
•4. Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the screening assessment, or are currently enrolled in an interventional investigational trial
•5. Any planned vaccination in the 4 weeks preceding screening, or at any point during the study
•6. Hypersensitivity to Proleukin or any of its excipients
•7. History of severe cardiac disease
•8. History of malignancy 5 years prior to screening (except adequately treated cervical carcinoma in situ, or basal and squamous cell skin carcinoma)
•9. Clinically significant renal, hepatic, or haematological abnormalities as defined in the study protocol
•10. Evidence of an active infection. Participants may be recruited a minimum of 48 hours after the resolution of illness or completion of antibacterial/antiviral therapy
•11. Pregnant or breastfeeding women; or male and female participants who do not agree to use a highly effective method of contraception during the study
•12. Any other factor deemed potentially relevant by the research team

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