Phase 1 Rheumatoid Arthritis 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 aged 18 to 65 years old (or the legal age of consent in the country where the trial is taking place) at the time of signing the consent form.
• People diagnosed with Rheumatoid Arthritis (RA) according to recognised international classification standards (2010 EULAR/ACR criteria).
• RA participants who have tested positive for at least one specific blood marker (either Rheumatoid Factor/RF or ACPA) confirmed by the trial's central laboratory.
• RA participants whose disease is rated as moderate or severe based on a standard scoring system (DAS28-CRP above 3.2, with at least 4 tender and 4 swollen joints; in the US, at least 6 tender and 6 swollen joints are required).
• RA participants who either could not tolerate, or did not respond well enough to, at least 2 different biologic or targeted treatments (with different mechanisms of action) after also trying at least one conventional disease-modifying drug — or where conventional treatment was not medically appropriate.
• People diagnosed with Systemic Lupus Erythematosus (SLE) according to recognised international classification standards (2019 EULAR/ACR criteria).
• SLE participants who have tested positive for at least one specific blood marker (ANA at a titre of 1:80 or higher, anti-dsDNA, or anti-Sm), confirmed by the central laboratory or from documented past test results.
• SLE participants whose disease is rated as moderate or severe based on a standard scoring system (clinical SLEDAI-2K above 4; in the US, a score of 6 or higher is required).
• SLE participants who either could not tolerate, or did not respond well enough to, at least 3 standard treatments from a specified list (including steroids, anti-malarials, and various immunosuppressive or biologic drugs) — there is no minimum treatment duration if the person could not tolerate the medication.
• People with a blood B-cell count of at least 50 cells per microlitre at the screening visit.
• People with a blood IgG (immunoglobulin G) level of at least 6 g/L at the screening visit.
• People currently taking certain permitted background medications at stable doses may be able to continue them during the trial, including low-dose oral steroids, anti-malarial drugs (such as hydroxychloroquine), and certain conventional immunosuppressive drugs at specified doses — confirm exact conditions with the trial site.
• People who previously participated in an earlier part of this trial and completed at least 90 days of treatment (or the full 6-month treatment period) without stopping due to a serious treatment-related side effect may be considered for re-treatment (confirm eligibility conditions with the trial site).

Who may not be able to join:

• People with serious disease complications judged by the trial doctor to be life-threatening or organ-threatening, including severe kidney disease driven by SLE, severe lung or heart involvement, a blood clotting disorder (antiphospholipid syndrome) causing an arterial or major vein clot within the past year (unless well-controlled by blood thinners or aspirin for at least 12 weeks), rapidly worsening or severe lung scarring (ILD) requiring oxygen, or a condition called Felty's syndrome.
• People with a history of a serious immune overactivation condition called HLH (haemophagocytic lymphohistiocytosis) or MAS (macrophage activation syndrome).
• RA participants who were diagnosed with juvenile idiopathic arthritis or any form of idiopathic arthritis before the age of 16.
• RA participants who have axial spondyloarthritis or another inflammatory joint disease in addition to RA.
• SLE participants with a history of active, severe, or unstable neurological or psychiatric complications of SLE (except headache or peripheral nerve problems).
• People with other active or previously documented serious autoimmune or inflammatory conditions — though some exceptions apply, including vitiligo, hair loss (alopecia), stable thyroid conditions managed with hormone replacement, well-controlled type 1 diabetes, certain chronic skin conditions not requiring systemic treatment, diet-controlled coeliac disease, and secondary Sjögren's disease where the main treatment is for RA or SLE (confirm with trial site).
• People with significant brain or nervous system conditions, such as Parkinson's disease, stroke, brain vasculitis, severe brain injury, dementia, epilepsy or seizure disorders, serious uncontrolled mental illness, psychosis, or a rare brain infection called PML.
• People with a known primary immune deficiency, a history of spleen removal, or any underlying condition that increases the risk of infection.
• People with any active infection at the time of screening.
• People who have had a serious opportunistic infection (a type of infection that takes advantage of a weakened immune system) within the past 3 years.
• People who have had a significant ongoing infection (such as bone or lung infections) where treatment was completed less than 2 months before signing the consent form (chronic nail infections are not excluded).
• People who have had an infection requiring hospital admission or intravenous (IV) antibiotics where treatment was completed less than 4 weeks before signing the consent form.
• People who have had any infection requiring oral antibiotic treatment within 2 weeks before signing the consent form.
• People with a history of repeated serious infections requiring hospitalisation or IV antibiotics (for example, 3 or more of the same type of infection, including systemic fungal infections, in the past 52 weeks).
• People with signs of active or latent (inactive) tuberculosis (TB), or who live with someone currently diagnosed with active TB — although people who have already completed a full course of appropriate TB treatment are not excluded, unless they had a drug-resistant form of TB.
• People who are HIV positive (confirmed by the central laboratory at screening).
• People with an active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection, assessed by the trial doctor.
• People with evidence of current or chronic Hepatitis B infection (based on specific blood test results at screening).
• People with evidence of current or chronic Hepatitis C infection, based on specific blood test results at screening — with some exceptions for people who have been successfully treated and have had undetectable virus levels confirmed (confirm conditions with trial site).
• People who test positive for COVID-19 at screening — although retesting after at least 2 weeks may be possible if the person otherwise meets all other criteria.
• People who have previously received certain treatments, including T-cell engaging therapies (except a specific drug called surovatamig under certain conditions), bone marrow transplant, stem cell transplant, total lymphoid irradiation, CAR-T cell therapy, or a drug called alemtuzumab.
• People who are currently pregnant, planning to become pregnant during the study period, or currently breastfeeding (applies to females only).

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