EUCTR2022-000801-28-IT招募中1 期
Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients with Relapsing Remitting Multiple Sclerosis - RED4MS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Cellerys AG
- 入组人数
- 142
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
- 性别
- All
入选标准
- •Part A and Part B
- •General inclusion criteria (to be assessed at the beginning of the screening period based on patient interview and medical history):
- •1. RRMS according to the 2017 McDonald criteria
- •2. Age 18-55 years
- •3. Disease duration (since diagnosis) <10 years
- •4. EDSS 0-5.5
- •5. =1 relapse or new CEL/T2 in previous 12 months (only Part B)
- •6. Untreated patients or patients being off therapy for the time periods mentioned under exclusion criterion No. 2
- •7. Only for sexually active female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a medically accepted method of contraception (defined in the study protocol) from the first (V1) to the last study visit in Part A and up to V11 (week 24) in Part B
- •8. Male patients willing to use contraception (condoms) from the first to the last study visit in Part A and from the V3 (week 1) to the V11 (week 24) in Part B unless surgically sterile
- •9. Basic immunization against SARS-CoV-2, i.e. both doses of two-dose vaccines (or one dose of a vaccine and a SARS-CoV-2 infection before or after vaccination) OR a dose of a single-dose vaccine
- •Specific qualification criteria (to be assessed during the baseline period):
- •10. = 2 cumulative new brain lesions (as defined above) on two MRI scans performed during baseline phase
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 142
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Part A and B
- •General exclusion criteria (to be assessed at the beginning of the screening period based on patient interview and medical history):
- •1. Patients with an active chronic disease (or stable but treated with immunomodulatory/-suppressive therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency)
- •2. Prior treatment with any of the medications below within the specified time-frame (please refer to the section 8.1.2 of protocol)
- •3. History of HIV, chronic or active Hepatitis C, chronic or active Hepatitis B or prior Syphilis, which has not been sufficiently treated
- •4. Long-COVID19 Syndrome
- •5. History of splenectomy or chronic liver disease
- •6. History of coronary artery disease, chronic heart failure, aortic stenosis
- •7. Current anticoagulation therapy
- •8. Uncontrolled grade II hypertension (=160 systolic and/or =100 diastolic blood pressure; according to ISH global practice guidelines) despite treatment or without treatment
- •9. History of stroke
- •10. Pregnant female confirmed by a positive pregnancy test or breastfeeding
- •11. History of alcohol or drug abuse within the 1 year prior to screening visit 1
- •12. History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ
- •13. History of or existing relevant central nervous system disorder (other than MS)
- •14. Allergy to gadolinium-based contrast agents
- •15. Any other disease or condition, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures
- •Specific exclusion criteria (to be assessed during the screening period):
- •16. Anemia, defined as hemoglobin levels =125 g/dl (7.25 mmol/l) for female and =135 g/dl (8.37 mmol/l) for male participants (may be repeated if 115 -125 g/dl in females and 125 - 135 g/dl in males)
- •17. Erythrocyte count <4.0 G/l in female and <4.5 G/l in male patients (may be repeated if >3.8 G/l in female and >4.3 G/l in male)
- •18. Lymphopenia with total lymphocyte counts = 1000/µl (may be repeated if >800/µl)
- •19. Positive HIV testing
- •20. Positive results of screening period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection
- •21. Patient is not eligible for blood donation according to local regulation
- •22. Having one or more of the following laboratory results (please refer to the section 8.1.2 of protocol)
研究者
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