CAR-T therapy is being explored beyond oncology as a potential strategy to deplete pathogenic B-cell populations and reset dysregulated immunity in autoimmune disease. Myasthenia gravis (MG) is an important area of investigation because antibody-producing B-lineage cells play a central role in disease biology.
This white paper presents early human data from an ongoing study of three patients with severe, refractory MG treated with GoFast™ CAR-T cells manufactured on the MARS Atlas® platform. The GoFast workflow integrates T-cell selection, activation and transduction, and harvest into an approximately 3-day manufacturing process, followed by sterility and QC release.
Across the three treated patients, circulating CD19+ B cells decreased rapidly following infusion, while CD8+ T-cell proportions increased during follow-up. In Patient 1, CAR-T expansion peaked at approximately 2,200 copies/µL around Day 14. All three patients showed improvement in MG-ADL scores and entered the Minimal Symptom Expression range during available follow-up. Early safety observations showed no dose-limiting toxicities, ICANS, or Grade ≥2 cytokine release syndrome. These preliminary findings support continued evaluation of rapidly manufactured GoFast CAR-T cells in autoimmune disease.
