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 — BIOLOGICAL
    Obecabtagene 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

Locations (2)

FacilityCityStateZIPSite coordinators
State University of New York Upstate Medical Center (SUNY)SyracuseNew York13210-
Texas Transplant InstituteSan AntonioTexas78229-

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