Controlling Hyperactive Immunity With Long-lived Lymphocytes

Ki vehet részt

• Participants must be at least 18 years of age at the time of signing the informed consent
• Up to date vaccination status and no planned vaccinations for post 3 months infusion
• Adequate haematological, liver and renal function
• Willing to undergo annual influenza vaccination
• Willing to enter a 15-year follow-up
• Eastern Cooperative Oncology Group (ECOG) performance status grade < 3
• Able and willing to use a highly effective method of contraception
• Stable dose of steroid prior to screening; Specific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only:
• Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria
• Diagnosis of D2TRA per 2021 EULAR criteria
• Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA
• Evidence of inflammation in target joints used for the DAS28 CRP assessment; Specific inclusion criteria for participants with diffuse cutaneous systemic sclerosis (dcSSc) only:
• Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria
• Serologically positive for antinuclear antibodies
• Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs)
• Skin involvement with a total modified Rodnan Skin Score of at least 15
• Evidence of lung fibrosis based on imaging or pulmonary function testing
• Evidence of active disease based on a validated SSc activity assessment

Ki nem vehet részt

• Immunodeficiency or receiving immunoglobulin replacement therapy
• Use of investigational agents within a pre-defined period prior to study screening
• Received a previous cell therapy
• Received certain B cell related experimental therapies in a clinical trial with the past year
• Any solid organ, bone marrow or stem cell transplant
• Receiving prohibited medication that cannot be stopped at screening
• History or concern of autoimmune diseases other than those under study
• Active infection, or recurrent chronic infection requiring intervention
• Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV
• Clinically significant cardiac dysfunction or severe pulmonary impairment
• History of malignancy in the past 5 years
• Presence of a significant medical condition(s), or clinically significant laboratory abnormality