Study on the Safety and Efficacy of CLS12311 and Autologous Red Blood Cells for Patients with Relapsing Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition known as Relapsing Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis characterized by periods of new or increasing symptoms followed by periods of partial or complete recovery. The study is testing a new treatment called CLS12311, which is a type of cell therapy. This treatment involves using a special form of red blood cells that are coupled with peptides, which are small proteins. The goal is to see if this treatment can help reduce the number of new lesions, or damaged areas, in the brain that are associated with inflammation in patients with RRMS.

The purpose of the study is to assess the safety and effectiveness of CLS12311 in patients with RRMS. The study will be conducted in two parts. In the first part, the focus will be on understanding how safe and tolerable the treatment is for patients. In the second part, the study will also look at how well the treatment works in reducing new brain lesions, which are detected using magnetic resonance imaging (MRI). Patients will receive the treatment through an intravenous infusion, which means it will be delivered directly into a vein.

Throughout the study, researchers will monitor patients for any side effects and changes in their condition. The study will also explore how the treatment affects certain immune cells and markers in the blood, which can provide insights into how the treatment works. The study is expected to continue until 2027, with recruitment of participants starting in 2024. This research aims to provide new insights into potential treatments for RRMS and improve the understanding of how this condition can be managed more effectively.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a baseline MRI scan to identify new brain lesions.

Eligibility criteria include being diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the 2017 McDonald criteria, aged between 18 and 55, and having a disease duration of less than 10 years.

2 baseline period

During the baseline period, additional MRI scans are performed to establish the number of new brain lesions. This helps in determining the patient’s qualification for Part B of the study.

Patients must have at least two new brain lesions on two MRI scans during this period to qualify for Part B.

3 treatment phase

The treatment involves the administration of autologous uncoupled red blood cells (RBCs) through intravenous infusion. The active substance is referred to as CLS12311.

The treatment phase is divided into two parts: Part A focuses on safety and tolerability, while Part B also assesses the efficacy of the treatment in reducing new brain lesions.

4 monitoring and follow-up

Throughout the treatment phase, regular monitoring is conducted to assess safety and efficacy. This includes tracking any adverse events and changes in disease activity through clinical evaluations and MRI scans.

The primary goal is to evaluate the safety and tolerability of CLS12311, as well as its effectiveness in reducing new brain lesions.

5 end of study

The study is expected to conclude by March 2027. At the end of the study, a final assessment is conducted to evaluate the overall outcomes of the treatment.

Participants are informed of the results and any potential next steps based on the findings of the study.

Who Can Join the Study?

Must have Relapsing Remitting Multiple Sclerosis (RRMS) according to the 2017 McDonald criteria.
Must be between 18 and 55 years old.
Must have had the disease for less than 10 years since diagnosis.
Must have an EDSS score between 0 and 5.5. The EDSS is a scale used to measure disability in people with multiple sclerosis.
For Part B, must have had at least 1 relapse or new brain lesions in the past 12 months.
Must be either untreated or have stopped therapy for a certain period. Patients should not be eligible for approved therapies or have chosen not to receive them after being informed.
Sexually active women who can have children must agree to use a highly effective method of birth control during the treatment and for at least 4 weeks after the last dose.
Men must agree to use condoms during the treatment and for at least 4 weeks after the last dose unless they are surgically sterile.
Must have received the basic COVID-19 vaccination, which means two doses of a two-dose vaccine, or one dose of a single-dose vaccine, or a combination of vaccination and infection.
For Part B, must have 2 or more new brain lesions on two MRI scans during the baseline phase. An MRI is a type of scan that creates detailed images of the inside of the body.

Who Cannot Join the Study?

Patients who do not have Relapsing Remitting Multiple Sclerosis (RRMS) cannot participate. RRMS is a type of multiple sclerosis where symptoms come and go.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not willing to undergo brain magnetic resonance imaging (MRI) cannot participate. An MRI is a scan that uses magnets and radio waves to create pictures of the inside of the body.
Patients who are part of a vulnerable population, which may include groups like children or pregnant women, cannot participate unless specified otherwise.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are important for safety and accuracy.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Technische Universitaet Dresden	Dresden	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
San Camillo Forlanini Hospital	Rome	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Ujpnhmttzk Mtmssxv Cvqdkn Hyoogjlrmlcxyvjoe	Hamburg	Germany
Fuzczggada Ilxntycrd Fao Tyfabzpgiuafp Mmozshpu Aym Pcclindyqdrv Iave	Goettingen	Germany
Fzhmwxus nhlqxulaa Mqyyt a Hcsbpgx	Prague	Czechia
Ulxduilkzchmvlxmjomgg Mwstdtkh Axq	Munster	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.06.2024
Germany	Not recruiting	01.06.2024
Italy	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Cls12311

CLS12311 is an investigational therapy being studied for its safety and effectiveness in patients with relapsing-remitting multiple sclerosis (RRMS). This therapy involves using the patient’s own red blood cells, which are coupled with specific peptides. The goal is to see if this treatment can reduce the number of new lesions in the brain, which are indicators of inflammation and disease activity in RRMS.

Investigated diseases:

Relapsing-remitting multiple sclerosis

Relapsing Remitting Multiple Sclerosis (RRMS) – This is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During these relapses, inflammation damages the protective covering of nerve fibers in the central nervous system, leading to symptoms such as fatigue, numbness, vision problems, and difficulty with coordination and balance. The disease progresses with alternating periods of relapses and remissions, where symptoms may improve or disappear entirely. Over time, some individuals may experience a gradual worsening of symptoms, even during remission phases. The frequency and severity of relapses can vary widely among individuals. RRMS is the most common form of multiple sclerosis at the time of diagnosis.

Trial ID:

2023-510127-30-00

Protocol code:

MSB-IG-H-2101

NCT ID:

NCT06430671

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study on the Safety and Efficacy of CLS12311 and Autologous Red Blood Cells for Patients with Relapsing Remitting Multiple Sclerosis

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