Obecabtagene autoleucel (obe-cel)
Obecabtagene autoleucel (obe-cel) is a CD19 CAR T-cell therapy developed by Autolus Therapeutics, sold as AUCATZYL. The next event is Phase 1 long-term results (CARLYSLE) for Obe-cel, expected Q4 2026 (source).
- Also known as
- AUCATZYL
- Company
- Autolus Therapeutics (AUTL) · Developer
- How it works
- CD19 CAR T cell therapy
- Approved
- AUCATZYL: United States, United Kingdom, European Union
Development by disease
| Acute lymphoblastic leukemia | Approved |
| Lupus nephritis | Phase 2 |
| B-cell non-hodgkin lymphoma | Phase 1b |
| Multiple sclerosis | Phase 1 |
| Systemic lupus erythematosus | Phase 1 |
Upcoming events
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in Q4 2026
- Q4 2026Obe-cel · Phase 1 long-term results (CARLYSLE) · Systemic lupus erythematosus
Expected in Q1 2027
- Q1 2027Obe-cel · Phase 1 interim results (BOBCAT) · Progressive multiple sclerosis
Past results and milestones
- Sep 9, 2026FDA granted RMAT designation for obe-cel in SLE and lupus nephritis. Source
- Dec 8, 2025Phase 1 CARLYSLE trial demonstrated deep B-cell depletion in all patients with no high-grade CRS or ICANS in 9 evaluable patients. Selected 50M cells as Phase 2 dose. Source
- Nov 12, 2025Autolus reported preliminary CATULUS data on November 12, 2025: about 95% overall response and nearly 90% of responders in ongoing remission at cutoff. The December ASH presentation refined the ORR to 95.5%. Source
- Oct 20, 2025reportedFirst patient successfully dosed in BOBCAT Phase 1 trial of obe-cel in progressive multiple sclerosis in October 2025. Phase 1 study designed to evaluate safety, tolerability, and preliminary efficacy in up to 18 adult patients with refractory progressive forms of MS. Source
- Jul 17, 2025European Commission granted conditional marketing authorization for AUCATZYL in adult patients age 26 and older with r/r B-ALL. Source
- Jun 12, 2025FELIX longer-term follow-up data presented at EHA Congress June 2025 demonstrated median duration of response of 42.5 months, 38.4% of responders in ongoing remission at 32.8-month follow-up, 24-month event-free survival of 43%, overall survival of 46%, with consolidating long-term plateau and no new safety signals. Source