QEL-005 cell therapy for diffuse cutaneous systemic sclerosis and hard-to-treat rheumatoid arthritis

Who can take part

• Participants must be at least 18 years of age at the time of signing the informed consent
• Specific inclusion criteria for participants with systemic sclerosis (SSc) only 1. Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) as per the 2013 ACR-EULAR criteria. 2. Serologically positive for antinuclear antibodies 3. Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs). 4. Skin involvement with a total modified Rodnan Skin Score of at least 15 5. Evidence of lung fibrosis based on imaging or pulmonary function testing 6. Evidence of active disease based on a validated SSc activity assessment
• Up to date vaccination schedule as per local guidance
• Adequate haematological, liver and renal function as assessed by the Investigator according to local laboratory tests
• 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
• Participants requiring oral steroids be on a stable dose of steroid prior to screening
• Specific inclusion criteria for participants with difficult to treat rheumatoid arthritis (D2TRA) only: 1. Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria 2. Diagnosis of D2TRA per 2021 EULAR criteria 3. Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA. 4. Evidence of inflammation in target joints used for the DAS28 CRP assessment

Who cannot take part

• Immunodeficiency or receiving immunoglobulin replacement therapy
• Receiving prohibited medications that cannot be stopped at screening
• Active 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 (TB), syphilis or HIV
• Participants with known clinically significant cardiac dysfunction or pulmonary disease
• History of malignancy within the past 5 years
• Presence of a significant medical condition(s), or clinically significant laboratory abnormality, that, in the Investigator's opinion, may impact participant safety or the participant’s ability to undergo study procedures