BMS’ CAR-T Therapy Shows Promising Results in Treating Lupus, Achieving Sustained Responses in Phase 1 Trial

BMS' CAR-T Therapy (CC-97540):
BMS presented data at the American College of Rheumatology Convergence 2024 on its CD19-directed autologous CAR T therapy, CC-97540, which showed significant improvements in lupus manifestations in seven SLE patients. Full B cell depletion was achieved by day eight, and patients remained in drug-free remission with no new signs of disease activity at the 11-month follow-up1.

Clinical Trial Outcomes:
The Phase I study demonstrated that CC-97540 could reset the immune system by depleting B cells, leading to reduced SLE activity and improved quality of life for patients. One patient successfully conceived and carried a child to birth after treatment, a significant outcome given that about one-third of women with lupus have antibodies that cause pregnancy issues1.

Safety Profile:
BMS reported one instance of grade 3 immune effector cell-associated neurotoxicity syndrome, which was fully resolved. The company considers the therapy to have a manageable safety profile with no unexpected adverse events1.

Future Studies:
BMS has initiated two multi-cohort Phase I studies to further evaluate the safety, tolerability, and efficacy of CC-97540 in systemic lupus erythematosus, idiopathic inflammatory myopathies, and systemic sclerosis1.

Industry Context:
CAR T therapies, which have proven effective in treating blood cancers, are now being explored for autoimmune diseases like lupus. Companies like BMS, Kyverna Therapeutics, Fate Therapeutics, and Cabaletta Bio are leading this effort, presenting promising data at recent conferences123.

Sources:

1. https://www.biospace.com/drug-development/car-t-for-lupus-takes-center-stage-at-acr-2024

2. https://www.fiercebiotech.com/biotech/cabalettas-2-patient-car-t-data-hint-autoimmune-remission-investors-want-more

3. https://www.bms.com/researchers-and-partners/areas-of-focus/our-research-in-immunology/taking-action.html