M.D. Anderson Cancer Center
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.
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…
Inclusion Criteria: SSc Specific Inclusion Criteria A. Diagnosis of SSc defined as follows: i) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening. B. SSc disease activity i) Diffuse SSc meeting the following criteria: (1) Disease duration ≤ 7 years (from onset of first non-Raynaud manifestation) AND (2) mRSS ≥ 15 at screening (Appendix 1) OR ii) Participants diagnosed with diffuse or limited cu…
Given by vein (IV)
Given by vein (IV)
Given by vein (IV)
Given by vein (IV)
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