Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

Inclusion criteria

• ✓. Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):
• ✓. FVC \< 80% predicted or extent of ILD changes on HRCT \> 20%. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and/or tocilizumab
• ✓. A clinical diagnosis of SLE, based on the 2019 EULAR/ ACR classification criteria for adult SLE.
• ✓. Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening or prior to screening.
• ✓. For LN subjects only: Active, biopsy-proven lupus nephritis (kidney biopsy should have been done within 1 year of study enrollment) class III or IV, with or without the presence of Class V, using the 2018 Revised International Society of Nephrology/Renal Pathology Society criteria48.
• ✓. Diagnosed with active SLE. Subjects with either LN or without LN will be eligible if they meet the following criteria:
• ✓. If a subject is currently receiving:
• ✓. A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject must be on a stable dose for at least 8 weeks prior to screening. A sodium-glucose cotransporter-2 (SGLT2) inhibitor, the subject must be on a stable dose for at least 8 weeks prior to screening.