Faculty

Vikas Majithia, M.D., M.P.H.

Clinical Studies

A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION) Scottsdale/Phoenix, AZ This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, In Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Or Rheumatoid Arthritis (Breakfree-1) Jacksonville, FL Rochester, MN The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION) Jacksonville, FL This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
A Phase 3, Randomized, Open-label, Multicenter Study To Compare The Efficacy And Safety Of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard Of Care In Participants With Active Systemic Sclerosis (Breakfree-SSc) Scottsdale/Phoenix, AZ Jacksonville, FL The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

A Phase 2, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, In Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response To Glucocorticoids And At Least 2 Immunosuppressants (Breakfree-SLE) Jacksonville, FL
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.