PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) laid out an ambitious 2026 roadmap centered on advancing rese-cel, its experimental CAR T cell therapy for autoimmune diseases, as the company moves toward its first potential FDA approval and scales up a fully automated manufacturing strategy.
The company said it is actively enrolling a registrational myositis trial designed to support a planned biologics license application in 2027. The pivotal cohort is expected to include 17 patients and will evaluate rese-cel as a single, weight-based infusion, including a potential outpatient dosing option.
Chief Executive Officer Steven Nichtberger said the strategy reflects a broader effort to pair clinical progress with manufacturing innovations that could dramatically expand access to cell therapy for patients with severe autoimmune disease.
“In 2026, we are focused on enrolling our pivotal myositis trial to support the planned rese-cel BLA submission next year while advancing paradigm-changing innovations,” Nichtberger said. He cited fully automated manufacturing, outpatient administration, and progress toward eliminating preconditioning chemotherapy as key differentiators for rese-cel.
The registrational myositis cohort, initiated in December 2025, targets dermatomyositis and antisynthetase syndrome, conditions affecting an estimated 70,000 patients in the United States. Data from earlier RESET-Myositis Phase 1/2 cohorts presented in 2025 showed all eligible dermatomyositis patients achieved the primary endpoint with durability extending up to one year, prompting Cabaletta to modestly expand enrollment.
Beyond myositis, Cabaletta said it has aligned with the FDA on registrational study designs in systemic lupus erythematosus and lupus nephritis, each planned as single-arm cohorts of roughly 25 patients. The company is strategically prioritizing development of rese-cel without preconditioning, pending dose-ranging data expected next year.
Regulatory momentum also continues in other indications. The FDA recently granted rese-cel Regenerative Medicine Advanced Therapy designation for systemic sclerosis, and Cabaletta expects additional updates on registrational pathways in systemic sclerosis and myasthenia gravis during 2026.
On the manufacturing front, Cabaletta said an amended investigational new drug application has cleared the use of the automated Cellares Cell Shuttle platform to produce rese-cel, marking the first such clearance for an autologous CAR T program. Multiple engineering runs demonstrated product consistency, and clinical manufacturing data expected in the first half of 2026 are intended to confirm full GMP readiness, including supply chain logistics.
Clinically, the company is also expanding experience with rese-cel without preconditioning. New durability data and higher-dose results from pemphigus vulgaris patients in the RESET-PV trial are expected in the first half of 2026, while dose-ranging data from lupus patients treated without preconditioning are anticipated later in the year.
Cabaletta said it expects complete Phase 1/2 data readouts across lupus, systemic sclerosis, and myasthenia gravis in the first half of 2026, setting the stage for what could be one of the most expansive CAR T development efforts yet in autoimmune disease.
Rese-cel, formerly known as CABA-201, is an investigational autologous CAR T therapy designed to reset the immune system through deep but transient depletion of CD19-positive cells, with the goal of achieving durable remission without chronic treatment.
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