The U.S. Food and Drug Administration has awarded regenerative‑medicine advanced therapy (RMAT) designation to obecabtagene autoleucel (obe‑cel) for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN). The designation, created under the 21st Century Cures Act to speed development of cell‑based therapies for serious diseases, was granted on the basis of Phase 1b data from Autolus' CARLYSLE trial.
Autolus Therapeutics, a commercial‑stage biopharmaceutical company, said enrollment continues in LUMINA, the pivotal Phase 2 study of obe‑cel in refractory lupus nephritis, which is recruiting patients across five countries. The company plans to present the next CARLYSLE data update at the American College of Rheumatology Annual Meeting in the fourth quarter of 2026 and expects LUMINA results in 2028.
"SLE and LN are serious autoimmune diseases with a critical unmet need for new therapeutic options, particularly for patients with severe refractory disease," said Dr. Matthias Will, Chief Development Officer of Autolus.
Autolus also markets AUCATZYL, a CAR‑T therapy for hematological malignancies, and maintains a pipeline targeting blood cancers, solid tumours and additional autoimmune indications.
