Clinical research endeavors currently underway in the Division of Rheumatology include:
Breakfree-1: A Study of CC-97540, CD19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases
A multicenter, international phase 1 clinical trial to evaluate the safety and efficacy of an autologous CD19-targeted CAR T cell therapy in participants with systemic lupus, scleroderma, or inflammatory myopathy
Breakfree-SLE: A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants
A multicenter, international phase 2 clinical trial to evaluate the safety and efficacy of an autologous CD19-targeted CAR T cell therapy in participants with treatment-resistant systemic lupus
LATTE Study: Alnuctamab for Refractory SLE
Investigator initiated phase 1 study evaluating the safety and efficacy of alnuctamab (TCE) for the treatment of moderate to severe, refractory lupus. We have connected with the Human Immune Monitoring Center to complete deep immune profiling for patients enrolled in the LATTE trial.
RESOLUTION: A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-Cell Therapy, in Adults with Autoimmune Disease
A multicenter phase 1 clinical trial to evaluate the safety and efficacy of an allogeneic CD19/CD70-targeted CAR T cell therapy in participants with systemic lupus, scleroderma, rheumatoid arthritis or inflammatory myopathy
KITE-363: A Study of Kite-363 in Participants With Refractory Autoimmune Diseases
A multicenter, international phase 1 clinical trial to evaluate the safety and efficacy of an autologous CD19/CD20-targeted CAR T cell therapy in participants with systemic lupus, scleroderma, or inflammatory myopathy
There are additional clinical research opportunities through the Mount Sinai Lupus Program, established in 2023 by Chrisanna Dobrowolski, MD, Assistant Professor, Medicine (Rheumatology), Icahn School of Medicine at Mount Sinai. This program provides specialized and comprehensive care for patients living with SLE in conjunction with a multidisciplinary team, including from Psychiatry and Complex Family Planning. This program also encompasses the Mount Sinai Lupus Cohort Study (registry and biorepository). Current areas of focus for the cohort include the use of wearable devices measuring physical activity, sleep quality and the bidirectional effects on immune dysregulation and disease activity, as well as cognitive health and quality of life.
Our fellows are also able to contribute to much-needed research in fibromyalgia where effective, cost-effective treatments are lacking. To address this unmet need, Michael Kaplan, MD, Assistant Professor, Medicine (Rheumatology), Icahn School of Medicine, established a multidisciplinary program at Mount Sinai, both as a resource for patients and a platform for innovative research.
VIPR: Vestibular Innovation in Pain 2
Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in participants with fibromyalgia. The VIPR trial will assess the efficacy of a single session of VCS, relative to sham, in treating pain and improving quality of life, using validated patient-reported outcomes.