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.
Parallel
Tafasitamab
DrugGiven by vein (IV)
Fludarabine phosphate
DrugGiven by vein (IV)
Cyclophosphamide
DrugGiven by vein (IV)
Tafasitamab and NK cells
DrugGiven by vein (IV)
Adverse Event
ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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