Phase 2 Lupus 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:

If you have Lupus (SLE) — Subprotocol A or B:

• You have been diagnosed with SLE (lupus) based on 2019 international classification guidelines.
• You have tested positive for at least one specific lupus-related antibody (ANA, anti-dsDNA, or anti-Smith) either at screening or based on past medical records.
• Your lupus disease activity score is at a certain level of severity (confirm with trial site).
• You have kidney involvement from lupus (lupus nephritis), confirmed by a kidney biopsy showing a specific type of kidney damage (Class III or IV, with or without Class V features).
• Your lupus kidney disease has not responded well enough to at least one (Subprotocol A) or two (Subprotocol B) standard kidney treatments, or you could not tolerate them.
• If you are already taking steroids, anti-malarial drugs, or certain other lupus medications, your doses must be within specific limits and stable for a set period before starting the trial.

If you have Rheumatoid Arthritis (RA) — Subprotocol C:

• You have been diagnosed with RA based on 2010 international classification guidelines.
• You have moderate to severe RA activity, with at least 3 swollen joints and 3 tender joints, confirmed at screening.
• Your RA has not responded well enough to at least one standard disease-modifying drug AND at least two biologic drugs of different types, or one biologic drug and one targeted synthetic drug — despite at least 12 weeks of treatment with each, or you could not tolerate them.
• You have an elevated inflammation marker (hsCRP) in your blood at screening (Subprotocol C Part B only).

Who may not be able to join:

For Lupus (SLE) participants — Subprotocol A and B:

• You received a live or live-attenuated vaccine within the 4 weeks before starting the trial drug, or plan to receive one during treatment.
• Your kidney function is significantly reduced (below a certain level, as measured by a blood test called eGFR) (confirm with trial site).
• You have serious, likely permanent organ damage caused by lupus, such as end-stage kidney disease.
• You are experiencing a sudden, severe lupus flare during the screening period that needs immediate treatment.
• You have previously had a kidney transplant, or are planning one during the trial.
• You have another kidney condition (unrelated to lupus) that could affect how your kidney disease is assessed, such as diabetic kidney disease.
• Your kidney biopsy shows only Class V lupus nephritis (Subprotocol A only).
• You have had active lupus affecting your brain or nervous system within the past year (Subprotocol B only).

For Rheumatoid Arthritis participants — Subprotocol C:

• You have a history of another inflammatory joint disease in addition to RA, such as lupus, scleroderma, or certain other conditions.
• Your RA has left you completely unable to perform self-care activities (the most severe level of physical limitation) (confirm with trial site).
• You have a history of significant nervous system conditions such as stroke, seizures, dementia, Parkinson's disease, or serious brain injury (also applies to Subprotocol B).

For all participants — Subprotocol A, B, and C:

• You have previously received any of the following treatments at any point: CAR T-cell therapy targeting B-cells, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or the drug natalizumab.

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