The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.
The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.
The goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.
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.
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.