In the open-label, phase 1 study, participants' own T cells will be extracted and engineered to target and eliminate autoreactive B cells and to potentially reset the immune system.
The first US patient has been enrolled in a groundbreaking study to evaluate the use of chimeric antigen receptor (CAR)-T cell therapy for the treatment of systemic lupus erythematosus (SLE), according to an announcement from Atlantic Health Systems, in Morristown, NJ
The multicenter, open-label, phase 1 study of CC-97540 (BMS-986353), focuses on individuals with severe, refractory SLE.
CAR-T cell therapy has revolutionized the treatment of many cancers. The new study will examine the safety and efficacy of the approach when applied to SLE, which in its most severe form can damage organs including the brain, heart, lungs, and kidneys. The typical range of symptoms includes muscle aches, joint pain and swelling, fatigue, fever, and rashes, often of debilitating intensity.
The potential for CAR-T therapy could be decisive in changing the course of care for many complex diseases. “CAR-T therapy continues to lead the field in research, representing a pivotal leap forward in our approach to treating patients, especially those facing complex medical challenges,” Mohamad Cherry, MD, medical director, hematology/oncology, Atlantic Health System and Medical Director, Atlantic Cellular Therapy Program, said in the announcement.
The research is a collaborative effort led by Cherry and principal investigator Neil Kramer, MD, co-founder of the Institute for Rheumatic and Autoimmune Diseases (IRAD) at Overlook Medical Center, in Summitt, NJ, and an expert in clinical management of SLE.
Cherry highlighted the joint effort’s promise, saying “We hope to collaboratively unlock novel avenues of care that will redefine the landscape of possibilities for these patients and their families.”
Cherry and Kramer’s combined focus is on the pivotal role of autoreactive B cells in SLE. They will use the study to explore the potential advantages of using CD19-specific CAR T cells to deplete CD19+ B cells. Using study participants’ own T cells, investigators will engineer them to target the circulating CD19+ B cells when reintroduced into the participant’s body. The goal is disease remission and possibly a resetting of the immune system.
Kramer emphasized the benefit to patients of the partnership between Atlantic Health's Cellular Therapy Program and the rheumatology programs. “The opportunity to provide lupus patients with access to this treatment, all while ensuring they receive the highest level of care, is a true testament to the collaboration between the cellular therapy and rheumatology programs,” he said in the statement. “It's not just a treatment; it's a collaboration between innovative science and compassionate care, empowering us to pioneer new horizons in patient wellbeing.”
Patients and clinicians interested in the trial can learn more by visiting the dedicated website.