Phase 1 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from the 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 are able to understand and are willing to sign a consent form agreeing to take part
• People of any gender are eligible
• People aged 18 to 75 years old
• People whose life expectancy is greater than 6 months
• People who have been diagnosed with rheumatoid arthritis (RA) according to recognised international classification guidelines (from 1987 or 2010)
• People whose RA is considered moderately to severely active at the time of screening
• People who have been on a stable, standard treatment plan for at least 30 days before the first dose
• People who have previously used antirheumatic drugs other than methotrexate (MTX), provided a specific washout period has been observed — for leflunomide, at least 8 weeks must have passed, or a 14-day course of cholestyramine must have been completed
• People whose blood test results show an elevated inflammation marker (ESR above 28mm/hr or CRP above 10mg/L)
• People who test positive for rheumatoid factor and/or a specific RA-related antibody (anti-CCP)
• People who have a type of immune cell called CD19+ B cells present in their blood
• People who have had a formal RA diagnosis for more than 6 months
• People whose organ function meets the required levels before the first dose (confirm with trial site for specific thresholds)
• People who are able and willing to attend all required visits, follow the treatment plan, and complete all study-related procedures
• People who are capable of having children must use highly effective contraception from 7 days before the first dose until 24 weeks after treatment ends, and must commit to not donating eggs or sperm for assisted reproduction for 1 year after the last study treatment; women who could become pregnant must have a negative pregnancy test within 7 days before the first dose

Who may not be able to join:

• People who have been diagnosed with another autoimmune rheumatic disease in addition to RA
• People who have received a B cell-targeted therapy within 6 months before starting this trial
• People who have received CAR-T cell therapy within 6 months before starting this trial
• People who have used anti-TNF medications within 8 weeks before the first dose
• People who have used any JAK inhibitor medication within 2 weeks before the first dose
• People who have used antimalarial drugs, sulfasalazine, penicillamine, or similar medications within 4 weeks before the first dose
• People who have used plant-based or herbal medicines within 4 weeks before the first dose
• People who have used other biological treatments or certain non-B cell depleting experimental drugs recently, where not enough time has passed since the last dose (confirm with trial site for specific timing)
• People who have had an injection directly into a joint within 4 weeks before entering the study
• People who have taken any other experimental drug within 28 days before the first dose, or within 5 half-lives of that drug
• People whose RA severely limits physical function to the point of being bedridden or wheelchair-bound (classified as ACR functional class IV)
• People who have had a major organ transplant, or a bone marrow or stem cell transplant
• People who have active hepatitis B, hepatitis C, HIV, or syphilis
• People who have a history of certain cardiovascular (heart or blood vessel) conditions within the 6 months before screening (confirm with trial site for specific conditions)
• People with poorly controlled high blood pressure (above 160/100 mmHg)
• People with a prolonged QT interval on a heart tracing (ECG) — above 450 milliseconds for men or 470 milliseconds for women
• People who have had significant bleeding within 30 days before screening, or who need ongoing blood-thinning medication
• People who have had an allergic reaction to recombinant humanised antibodies or to any ingredient in the study drug GNC-038
• People who are pregnant or breastfeeding
• People who have had suicidal thoughts within 6 months before signing the consent form, where the trial investigator considers this a significant risk
• People who have been diagnosed with a malignant (cancerous) tumour within the past 5 years
• People who, in the investigator's judgement, are unlikely or unwilling to follow the study requirements
• People who have had their spleen removed
• People who have a history of alcohol or drug misuse in the 12 months before screening, as assessed by the investigator
• People who have an active infection requiring antibiotic treatment within 2 weeks before or during the screening period
• People who have a history of a severe or widespread viral infection
• People who may have an active tuberculosis (TB) infection

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