Spotlight On: Cabaletta Bio’s Small but Mighty Breakthrough for CAR-T in Autoimmune Arena
Cabaletta Bio's CAR-T therapy, known as rese-cel (resecabtagene autoleucel), has shown robust clinical benefits across multiple autoimmune diseases, including lupus, myositis, systemic sclerosis, and pemphigus vulgaris457.
Recent clinical results demonstrate that rese-cel can achieve deep and sustained B cell depletion, leading to rapid improvements in symptoms and clinical markers5712.
A major breakthrough highlighted is the ability of rese-cel to provide complete B cell depletion without preconditioning chemotherapy—a departure from traditional CAR-T protocols that reduces toxicity and broadens patient eligibility512.
In the RESET-PV trial for pemphigus vulgaris, two patients achieved complete B cell depletion and one achieved partial depletion, all with marked early clinical improvements, without preconditioning5.
Updated phase 1/2 data from the RESET program showed that a significant proportion of lupus patients achieved remission and renal response after a single infusion, with nearly all patients able to discontinue immunomodulators and steroids47.
Rese-cel has been well tolerated; only mild adverse events (such as grade 1 cytokine release syndrome and mild fever) were reported, with no immune effector cell-associated neurotoxicity syndrome (ICANS) in recently reported data513.
The simplified, one-time, weight-based dosing regimen and elimination of preconditioning present a potentially paradigm-shifting approach for curative cell therapy in autoimmune diseases5712.
Cabaletta Bio is accelerating its RESET clinical program, with over 50 patients enrolled across more than 65 sites, and is pursuing FDA alignment for registrational (pivotal) trials in myositis, lupus, systemic sclerosis, and myasthenia gravis712.
Analysts highlight that removing the need for preconditioning could be a 'colossal differentiator' in the CAR-T autoimmune space, though limitations include small cohorts and short-term follow-up so far512.
Sources:
4. https://www.fiercebiotech.com/biotech/cabalettas-car-t-shows-robust-benefit-lupus-patients-teeing-registrational-trial-plans
5. https://www.fiercebiotech.com/biotech/cabalettas-car-t-therapy-wipes-out-b-cells-small-autoimmune-trial-without-preconditioning
7. https://www.cabalettabio.com/news-media/press-releases/detail/130/cabaletta-bio-announces-new-rese-cel-safety-and-efficacy