Meetings & Presentations2026-09-09

Obe-cel - (CARLYSLE)

Autolus Therapeutics plcAUTL
Indication
Systemic Lupus Erythematosus (SLE)
Stage
phase1
Event
End of Phase Meeting
Details

September 09, 2026: Autolus Therapeutics plc (NASDAQ: AUTL) said the FDA granted regenerative medicine advanced therapy (RMAT) designation to obecabtagene autoleucel (obe-cel) for systemic lupus erythematosus (SLE) and lupus nephritis (LN). The designation was based on Phase 1b data from the CARLYSLE trial and is intended to help accelerate development and regulatory review.

Autolus said the next data update from the Phase 1 CARLYSLE trial in SLE has been submitted for presentation at the American College of Rheumatology (ACR) Annual Meeting in 4Q 2026.

The company also said LUMINA, its pivotal Phase 2 study of obe-cel in refractory LN, is continuing to enroll patients in five countries, with data expected in 2028.