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

Launched by ARTIVA BIOTHERAPEUTICS, INC. · Feb 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AB-101, which is a type of cell therapy using "natural killer" cells, for adult patients with lupus nephritis (specifically Class III or IV) who have not responded to previous treatments. The goal is to see how safe and effective AB-101 is when combined with another medication that targets B-cells (a type of immune cell). Patients will have the chance to receive either AB-101 alone or in combination with a B-cell depleting medication, and they will be monitored for their overall health and response to the treatment.

To be eligible for this trial, participants need to be adults with confirmed lupus nephritis Class III or IV, have evidence of active disease, and have shown that previous standard treatments did not work for them. They should also have specific antibodies present in their blood. Participants will receive at least one cycle of treatment, with the possibility of two cycles spaced 24 weeks apart. The trial is currently recruiting patients and aims to provide new options for those struggling with this challenging condition.

Gender

ALL

Eligibility criteria

• • 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