Phase 1 and 2 Study of AD-PluReceptor Plus Tafasitamab and Chemotherapy for Autoimmune Disorders Including Systemic Sclerosis and Lupus

What this Trial Is About

Researchers are evaluating the safety and optimal dosing of AD-PluReceptor-NK cells combined with tafasitamab and lymphodepleting chemotherapy in patients with autoimmune disorders such as systemic sclerosis SSc, systemic lupus erythematosus SLE, including lupus nephritis LN, and chronic graft versus host disease GVHD. This Phase III trial aims to confirm safety in an initial safety lead-in, find the recommended dose in Phase 1, and assess disease control in Phase 2. The study also seeks to understand immune response and the ability to reduce systemic immunosuppressive therapy at one year. Participants receive tafasitamab and AD-PluReceptor-NK cells intravenously along with lymphodepleting chemotherapy drugs, including fludarabine phosphate and cyclophosphamide, also given intravenously. The study includes a safety lead-in period, a dose escalation phase to identify the best cell dose, and a dose expansion phase to evaluate treatment effects. Treatments are combined and administered under medical supervision during these phases. During the trial, participants undergo regular monitoring for adverse events over an average of one year, with blood tests to assess immune cell persistence and function. Evaluations include safety, tolerability, organ function, and disease activity measures. Participants also follow study visit schedules and complete required assessments to track treatment effects and safety throughout the study period ending in 2030.

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