Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Autolus Limited
Study ID
NCT07053800
Phase
PHASE2
Status
Recruiting
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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

This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to systemic lupus erythematosus (SLE)/lupus nephritis (LN) when available treatments have not worked (refractory). The trial includes only 1 group of patients (single arm), including adolescent and adult patients aged 12 to 65 years. The objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after obe-cel treatment in patients with severe, active LN. The trial will also look for other benefits of obe-cel for up to 24 months after treatment, including the percentage of patients who respond to obe-cel treatment, SLE/LN activity, time to and length of remission, and quality of life. The trial will also assess how long obe-cel stays in the body and the safety of obe-cel.

Key Dates

Start date
Jan 16, 2026
Status verified
Apr 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) at 6 months post-obe-cel infusion without rescue medications, among all participants who received obe-cel infusion [ Time Frame: Month 6 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Center at Canyon SpringsGilbertArizona85234-
City of HopeDuarteCalifornia91010-
Stanford UniversityStanfordCalifornia94305-
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Tampa General HospitalTampaFlorida33606-
EmoryAtlantaGeorgia30322-
The Tisch Cancer Institute - 1470 Madison AvenueNew YorkNew York10029-
State University of New York Upstate Medical Center (SUNY)SyracuseNew York13210-
Accurate Clinical Research Inc - VictoriaHoustonTexas77034-
Texas Childrens Hospital/BaylorHoustonTexas77030-
Texas Transplant InstituteSan AntonioTexas78229-

Find similar trials in Gilbert, AZ

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Banner MD Anderson Cancer Center at Canyon Springs· Gilbert, AZCity of Hope· Duarte, CAStanford University· Stanford, CAH Lee Moffitt Cancer Center and Research Institute· Tampa, FLTampa General Hospital· Tampa, FLEmory· Atlanta, GA

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