Autolus Therapeutics Presents Longer-Term Follow Up Data From Ongoing CARLYSLE Phase 1 Trial; Data Show Clinically Significant Improvements In SLEDAI-2K Scores And Achievement Of DORIS In Most Patients Despite Severe Disease Activity At Baseline
Benzinga Newsdesk 2 hours ago
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Fonger-term follow up data from the ongoing CARLYSLE trial, a Phase 1 dose confirmation clinical trial of obe-cel in severe refractory systemic lupus erythematosus (srSLE), was presented today during a poster session at
Fonger-term follow up data from the ongoing CARLYSLE trial, a Phase 1 dose confirmation clinical trial of obe-cel in severe refractory systemic lupus erythematosus (srSLE), was presented today during a poster session at the American College of Rheumatology (ACR) Convergence 2026.
Abstract: 2422875 – Poster Presentation
Title: Obecabtagene autoleucel (obe-cel), a CD19-targeting Chimeric Antigen Receptor (CAR) T-cell Therapy, in Adults and Adolescents with Severe, Refractory Systemic Lupus Erythematosus (srSLE): Findings from the Phase I CARLYSLE Study
Session: Poster Session C (2192-2227) Systemic Lupus Erythematosus
Session date and time: Tuesday, November 10; 10:30 AM–12:30 PM ET
Summary: The poster presents safety and efficacy results from the Phase I CARLYSLE study with up to 25 months follow-up in adult patients. As of August 11, 2026, 15 patients were infused with obe-cel at a dose of 50M (8 adults, 3 adolescents) or 100M (4 adults). Median follow-up [range] in the adult 50M, adult 100M, and adolescent 50M cohorts was 19.0 [1.0–25.5] months, 12.4 [3.3–16.4] months, and 10.1 [8.5–11.5] months, respectively. All patients had evidence of active srSLE and 66.7% had class III or IV LN, with or without class V. Obe-cel was well tolerated in adult and adolescent participants with srSLE, with no ICANS or HLH/IEC-HS, and no high-grade CRS events. Response data showed clinically significant improvements in SLEDAI-2K and achievement of DORIS in most participants, including 100% of patients followed for a minimum of six months, despite severe disease activity at baseline. In patients followed for a minimum of six months, complete renal response (CRR) was achieved in 6/9 (66.7%) participants at any time post obe-cel infusion. One participant (11.1%) achieved partial renal response (PRR) with onset at Month 7. No severe renal flares were observed. Robust CAR T-cell expansion and deep B-cell depletion were observed in all cohorts after infusion and participants showed reconstitution with predominantly transitional/naïve B-cell phenotypes. Median time to B-cell recovery was 7.2 months in 50M adult, 4.3 months in 100M adult and 6.0 months in 50M adolescent cohorts.
Obe-cel is being evaluated in the Phase II LUMINA trial in participants with srSLE with active LN, using a single flat dose of obe-cel at 50×10⁶ (50M).