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

Description

Primary Objectives:

To determine the safety, tolerability and optimal cell dose of AD-PluReceptor plus Tafasitamab cxix and lymphodepleting chemotherapy in patients with systemic sclerosis and systemic lupus erythematosus (including lupus nephritis).

Secondary Objectives:

To assess the overall response rate.

To evaluate the persistence and kinetics of infused allogeneic donor AD-PluReceptor cells in the recipient.

To conduct comprehensive immune reconstitution studies.

To evaluate the number of patients not requiring any systemic immunosuppressive therapy for their autoimmune disease at 1 year post infusion.