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

Exclusion criteria

• . SSc related pulmonary arterial hypertension (PAH) requiring active treatment.
• . Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.
• . Prior scleroderma renal crisis.
• . Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \< 40% or FVC \< 40% of predicted or O2 saturation \< 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.
• . For LN subjects only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following
• . The presence of biopsy-proven kidney disease other than active lupus nephritis
• . Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \< 40% or FVC \< 40% of predicted or O2 saturation \< 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.Active, severe cardiac manifestations of SLE, including constrictive pericarditis, hemodynamically significant pericardial effusions, and myocarditis at the time of screening.
• . Treatment with any immunosuppressive drug (except steroids) within 5 half lives prior to administration of lymphodepleting therapy.