Phase 2 Multiple Sclerosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with systemic sclerosis (a condition also known as scleroderma) that affects a large area of skin, classified as the "diffuse cutaneous" type, according to recognised international diagnosis guidelines.
• People whose first symptoms of systemic sclerosis (other than Raynaud's phenomenon — for example, puffy hands, skin tightening, finger ulcers, joint pain, or breathlessness) started within the last 7 years.
• People whose systemic sclerosis is severe and getting worse, with at least one of the following: worsening lung scarring linked to their condition, severe and worsening skin disease, or significant heart problems linked to their condition.
• People who have received all vaccinations recommended for individuals with a weakened immune system, in line with their local or international health guidelines.

Who may not be able to join:

• People whose current medications cannot be fully cleared from their system within the timeframe required by the study, or who the treating doctor considers unsuitable for the type of therapy used in this trial.
• People who have had an allergic reaction to any ingredient in the study treatment (rapcabtagene autoleucel) or to a medicine called rituximab.
• People for whom the treating doctor considers treatment with rituximab to be medically inappropriate.
• People who have other serious health conditions unrelated to their systemic sclerosis that the treating doctor believes could make it unsafe to receive the preparatory treatment or the main study therapy.
• People who have a rheumatic disease other than the diffuse cutaneous type of systemic sclerosis (with the exception of secondary Sjögren's syndrome or muscle involvement related to scleroderma), including those with the limited cutaneous type or a form without obvious skin involvement.
• People who have pre-existing pulmonary hypertension (high blood pressure in the lungs).
• People who have significant kidney problems at the time of screening.
• People who have high blood pressure that is not well controlled at the time of screening (confirm with trial site for exact measurement thresholds).
• People who have received a live vaccine within 6 weeks before the point of enrolment into the trial.

Important: Always verify eligibility with the trial site directly before applying.