eligibility_summary
Eligibility: Adults 18–65 with consent, vaccination, adequate organs and LVEF, contraception. SSc: 2013 ACR/EULAR+ANA≥1:80, diffuse≤5y mRSS≥15 or diffuse/limited+progressive ILD≤5y, FVC<80%+mod–severe ILD, failed≥2(MMF,CYC,RTX,TCZ). SLE: 2019 ACR/EULAR+ANA≥1:80 or anti‑dsDNA, LN class III/IV(±V) UPCR≥1, or non‑renal SLEDAI‑2K≥8 clinical≥6, failed≥2 SOC, stable meds, eGFR≥45/60. Excl: SSc PAH, severe GI/renal crisis or advanced ILD, biologics/CNI/RTX, kidney chronicity or APS, infections.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II trial in SSc/SLE/LN testing: 1) Tafasitamab‑cxix: Fc‑engineered anti‑CD19 monoclonal antibody (IgG1), depletes B cells via ADCC, phagocytosis, and apoptosis. 2) AD‑PluReceptor‑NK cells: off‑the‑shelf allogeneic engineered NK cell therapy designed to augment antibody‑directed killing, combined with tafasitamab to eliminate CD19+ B cells. 3) Lymphodepleting chemotherapy: fludarabine phosphate (purine‑analog antimetabolite) and cyclophosphamide (alkylating agent) to transiently deplete host lymphocytes and support NK‑cell engraftment. Targets/pathways: CD19+ B‑cell compartment driving autoimmunity, Fcγ‑mediated ADCC, innate NK cytotoxicity, and immune reconstitution.