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A SINGLE-ARM, OPEN-LABEL, PHASE II STUDY TO DETERMINE THE SAFETY AND EFFICACY OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN PARTICIPANTS WITH SEVERE, REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS WITH ACTIVE LUPUS NEPHRITIS

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519941-32-00
Acronym
AUTO1-SL2
Enrollment
3
Registered
2025-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus with Active Lupus Nephritis

Brief summary

Proportion of participants with CRR, defined as: • Urine Protein Creatinine Ratio (UPCR) ≤ 0.5 mg/mg AND • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 or no decrease from baseline eGFR of > 20% AND • Did not receive rescue medicine Time frame: Month 6

Detailed description

Remission rate as specified by DORIS Time Frame: Month 6, Proportion of participants with CRR. Time Frame: Up to Month 24, Time to CRR. Time Frame: Up to Month 24, Duration of CRR. Time Frame: Up to Month 24, Proportion of participants with PRR, defined as: • ≥ 50% reduction in UPCR from baseline Time Frame: Up to Month 24, Time to PRR. Time Frame: Up to Month 24, Duration of PRR. Time Frame: Up to Month 24, Remission over time, time to response, as specified by DORIS Time Frame: Up to Month 24, Time to renal event. Renal event defined as: • Confirmed decrease from baseline in eGFR (pre-specified as a > 30% decrease) Time Frame: Up to Month 24, SLEDAI-2K score over time and proportion of participants achieving SLEDAI-2K score of 0. Time Frame: Up to Month 24, Remission over time, time to remission, and duration of remission as specified by the definition of remission in LLDAS. Time Frame: Up to Month 24, Time from obe-cel infusion to first disease flare as specified by the definition of flare in SFI NOTE: SLEDAI-2K will be used to score SFI. Time Frame: Up to Month 24, Change from baseline in PGA Time Frame: Up to Month 24, Change from baseline in FACIT-Fatigue score Time Frame: Up to Month 24, Change from baseline in HAQ-DI Time Frame: Up to Month 24, Change from baseline in SF-36 Time Frame: Up to Month 24, Change from baseline in EQ-5D Time Frame: Up to Month 24, Frequency and duration of hospitalization and/or critical care support to manage obe-cel-related toxicity Time Frame: Up to Month 24, Frequency, severity and duration of CRS, ICANS, and other identified risks Time Frame: Up to Month 24, Adverse event (AE) type, frequency, severity, and relationship with obe-cel or lymphodepletion, safety laboratory samples, vital signs Time Frame: Up to Month 24, Detection of CAR T cells Time Frame: 9 timepoints post-infusion between Days 1 and 28, followed by Month 2, Month 3, then 3-monthly to month 24, Change from baseline in serum autoantibody concentration (antinuclear antibody [ANA], anti-double stranded DNA [anti-dsDNA], anti-Smith, anti-RNA binding protein [anti-RBP]) Time Frame: Pre-infusion at Day -6 and post-infusion at Day 28, Month 3, then 3-monthly to Month 12 and 6-monthly to Month 24, Change from baseline in the complement panel (complement, total [CH50], C3, C4) Time Frame: Pre-infusion at Day -6 and post-infusion at Day 28, Month 3, then 3-monthly to Month 12 and 6-monthly to Month 24, Change from baseline in PtGA Time Frame: Up to Month 24, Detection of B cells in the peripheral blood over time Time Frame: Pre-infusion at screening and Day -6 and post-infusion at Day 1, Day 28, Month 2, Month 3, then 3-monthly to Month 12 and 6-monthly to Month 24, Change from baseline in the antiphospholipid profile (lupus anticoagulant, anticardiolipin antibodies and beta-2 glycoprotein) Time Frame: Pre-infusion at Day -6 and post-infusion at Day 28, Month 3, then 3-monthly to Month 12 and 6-monthly to Month 24

Interventions

DRUGAUTO1
DRUGFludara 50 mg powder for solution for injection or infusion

Sponsors

Autolus Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Proportion of participants with CRR, defined as: • Urine Protein Creatinine Ratio (UPCR) ≤ 0.5 mg/mg AND • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 or no decrease from baseline eGFR of > 20% AND • Did not receive rescue medicine Time frame: Month 6

Secondary

MeasureTime frame
Remission rate as specified by DORIS Time Frame: Month 6, Proportion of participants with CRR. Time Frame: Up to Month 24, Time to CRR. Time Frame: Up to Month 24, Duration of CRR. Time Frame: Up to Month 24, Proportion of participants with PRR, defined as: • ≥ 50% reduction in UPCR from baseline Time Frame: Up to Month 24, Time to PRR. Time Frame: Up to Month 24, Duration of PRR. Time Frame: Up to Month 24, Remission over time, time to response, as specified by DORIS Time Frame: Up to Month 24, Time to renal event. Renal event defined as: • Confirmed decrease from baseline in eGFR (pre-specified as a > 30% decrease) Time Frame: Up to Month 24, SLEDAI-2K score over time and proportion of participants achieving SLEDAI-2K score of 0. Time Frame: Up to Month 24, Remission over time, time to remission, and duration of remission as specified by the definition of remission in LLDAS. Time Frame: Up to Month 24, Time from obe-cel infusion to first disease flare as specified by the definition

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026