Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 142

Inclusion Criteria

Part A and Part B
General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history):
1. RRMS according to the 2017 McDonald criteria
2. Male or female patients (assigned at birth) aged 18-55 years
3. Disease duration (since diagnosis) <10 years
4. EDSS at baseline 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 listed under exclusion criterion No. 2. Patients are either not eligible to receive approved therapies or have explicitly chosen not to receive such therapies after being adequately informed by the investigators
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 highly effective method of contraception (defined in the study protocol) throughout the complete treatment phase or at least for 4 weeks after the last dose of CLS12311
8. Male patients willing to use contraception (condoms) throughout the complete treatment phase or at least for 4 weeks after the last dose of CLS12311 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

Part B
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

Exclusion Criteria

Part A and B
General exclusion criteria (to be assessed at the beginning of the baseline 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:
a. glatiramer acetate, interferon-beta within 4 weeks prior to screening visit 1
b. dimethylfumarate, diroximel-fumarate within 4 weeks prior to screening visit 1
c. teriflunomide within 4 weeks prior to screening visit 1, provided accelerated elimination procedure (eg. cholestyramine) was performed and teriflunomide plasma level are below 0.02 mg/L before randomization
d. fingolimod, ozanimod within 12 weeks prior to screening visit 1, provided normal lymphocyte counts (see exclusion criterion No. 18)
e. siponimod, ponesimod within 8 weeks prior to screening visit 1, provided normal lymphocyte counts (see exclusion criterion No. 18)
f. natalizumab within 12 weeks prior to screening visit 1
g. ocrelizumab, ofatumumab, rituximab, alemtuzumab, cladribine, mitoxantrone within 52 weeks prior to screening visit 1
h. plasma exchange, intravenous immunoglobulin within 8 weeks prior to screening visit 1
i. azathioprine, methotrexate, cyclophosphamide or any other continuous immunosuppressive therapy within 24 weeks prior to screening visit 1
j. any other immunosuppressive monoclonal antibody treatment within 24 weeks prior to screening visit 1
k. Prior autologous hematopoietic stem cell transplantation
l. Corticosteroid treatment for MS relapse within 4 weeks prior to screening visit 1
m. Patients who participated in the ETIMSred trial
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 breast-feeding
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 baseline period):
16. Anemia, defined as hemoglobin levels =12.5 g/dl (7.25 mmol/l) for female and =13.5 g/dl (8.37 mmol/l) for male participants (may be repeated if 11.5 -12.5 g/dl in females and 12.5 - 13.5 g/dl in males)
17. Erythrocyte count <4.0 E12/L in female and <4.5 E12/L in male patients (may be repeated if >3.8 E12/L in female and >4.3

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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