AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus

Inclusion criteria

for all subjects (Lupus Nephritis or SLE)

• Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria
• Subjects must have had an inadequate response with at least two prior lines of standard of care (SoC) treatment.

Inclusion criteria

for LN:

• Adult subjects with lupus nephritis Class III or IV (with or without the presence of Class V)
• Evidence of active disease on renal biopsy.
• All subjects are required to receive adequate concomitant antihypertensive and antiproteinuric therapy with blockade of the renin-angiotensin system

Inclusion criteria

for SLE:

• Total systemic lupus erythematosus disease activity index (SLEDAI-2K score) ≥ 8, and clinical SLEDAI-2K ≥ 4.
• British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥ 1 organ, or a BILAG-2004 activity score of B in ≥ 2 organs.
• Subjects have failed at least two conventional therapies

Exclusion criteria

• Known past or current malignancy
• Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE
• Subjects with known active viral infections
• Severe active CNS Lupus