Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Part of paid clinical trials in Syracuse, New York.
- Sponsor
- Autolus Limited
- Study ID
- NCT07053800
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Obecabtagene autoleucel — BIOLOGICALObecabtagene autoleucel (obe-cel) given as a single infusion
Study Details
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).
Key Dates
- First listed
- Jul 8, 2025
- Start date
- Jan 16, 2026
- Status verified
- Jul 2026
- Primary completion
- Aug 31, 2028
- Completion
- Oct 31, 2029
Study Design
- Enrollment
- 35 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Obe-cel
Primary Outcome Measure
Proportion of participants who achieve complete renal response (CRR) [ Time Frame: Month 6 ]
Central Contacts
- Autolus Ltd+44 (0)203 911 4385
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| State University of New York Upstate Medical Center (SUNY) | Syracuse | New York | 13210 | - |
| Texas Transplant Institute | San Antonio | Texas | 78229 | - |
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