Ended Human Pharmacology (Phase I)- First administration to humans Relapsing Remitting Multiple Sclerosis (RRMS)

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

EU CTIS ID: 2023-510127-30-00

What this study is testing

Safety objective: To assess the safety and tolerability of CLS12311 in patients with RRMS

Human Pharmacology (Phase I)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: RRMS according to the 2017 McDonald criteria
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Male or female patients (assigned at birth) aged 18-55 years
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Disease duration (since diagnosis) <10 years
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: EDSS at baseline 0-5.5
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Untreated patients or patients being off therapy for the time periods mentioned 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
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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

You likely can't join if

[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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)
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Pregnant female confirmed by a positive pregnancy test or breastfeeding
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of alcohol or drug abuse within the 1 year prior to screening visit 1
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of or existing relevant central nervous system disorder (other than MS)
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Allergy to gadolinium-based contrast agents

See the full eligibility criteria

Who can join

[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: RRMS according to the 2017 McDonald criteria
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Male or female patients (assigned at birth) aged 18-55 years
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Disease duration (since diagnosis) <10 years
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: EDSS at baseline 0-5.5
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Untreated patients or patients being off therapy for the time periods mentioned 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
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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
[General inclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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

What rules you out

[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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)
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Pregnant female confirmed by a positive pregnancy test or breastfeeding
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of alcohol or drug abuse within the 1 year prior to screening visit 1
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of or existing malignancy within the last 5 years prior to enrolment except history of basal cell carcinoma and melanoma in situ
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of or existing relevant central nervous system disorder (other than MS)
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Allergy to gadolinium-based contrast agents
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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)]: 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)
[Specific exclusion criteria (to be assessed during the baseline period)]: Erythrocyte count 3.8 E12/L in female and >4.3 E12/L in male)
[Specific exclusion criteria (to be assessed during the baseline period)]: Lymphopenia with total lymphocyte counts ≤ 1000/µl (may be repeated if >800/µl)
[Specific exclusion criteria (to be assessed during the baseline period)]: Positive HIV testing
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: 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
[Specific exclusion criteria (to be assessed during the baseline period)]: Positive results of screening period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection
[Specific exclusion criteria (to be assessed during the baseline period)]: Positive results of screening period testing for serological markers for hepatitis B, C, and Syphilis indicating acute or chronic infection
[Specific exclusion criteria (to be assessed during the baseline period)]: Having one or more of the following laboratory results: a. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (may be repeated if eGFR is 45-59 mL/min/1.73 m2); b. ALT or AST > 3 x upper limit of normal (ULN; may be repeated if 3.1-4 x ULN); c. Total bilirubin greater than 2 x ULN (may be repeated if 2.1 - 3 x ULN), with the exception for patients with Gilbert's disease; d. Platelet count ≤ 100E9/L (may be repeated if 80-100E9/L); e. Abnormalities in hepatic synthetic function tests (PT time, INR, PTT, albumin) as judged by the Investigator to be clinically significant
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of HIV, chronic or active Hepatitis C, chronic or active Hepatitis B or prior Syphilis, which has not been sufficiently treated
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Long-COVID19 Syndrome
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of splenectomy or chronic liver disease
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of coronary artery disease, chronic heart failure, aortic stenosis
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Current anticoagulation therapy
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: Uncontrolled grade II hypertension (≥160 systolic and/or ≥100 diastolic blood pressure; according to ISH global practice guidelines) despite treatment or without treatment
[General exclusion criteria (to be assessed at the beginning of the baseline period based on patient interview and medical history)]: History of stroke

The study team makes the final eligibility decision.

Where it's taking place

Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.