Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis (NCT06430671) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
Czechia, Germany11 participantsStarted 2024-06-18
Plain-language summary
RED4MS is a clinical trial to assess the safety and tolerability of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. RRMS according to the 2017 McDonald criteria
✓. Male or female patients (assigned at birth) aged 18-55 years inclusive
✓. Disease duration (since diagnosis) \<10 years
✓. Expanded Disability Status Scale (EDSS) at baseline 0-5.5
Exclusion criteria
✕. Only for 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 throughout the treatment phase or at least for 4 weeks after the last dose of the study drug
✕. Male patients willing to use contraception (such as a condoms) throughout the treatment phase or at least for 4 weeks after the last dose of the study drug, unless surgically steril
✕. 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)
✕. Prior treatment with any of the medications specified in the protocol
✕. History of HIV, chronic or active Hepatitis, chronic or active Hepatitis B or Syphilis
✕. Long-Covid19 syndrome
✕. History of splenectomy or chronic liver disease
What they're measuring
1
Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311]