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Obecabtagene autoleucel

Phase 2

Lupus Nephritis | Monoclonal antibody | Immunology |Autolus Therapeutics plc|Last Updated: Apr 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07053800Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus NephritisPHASE2 RECRUITING 35Jan 16, 2026Oct 1, 2029Apr 27, 202626 United States, Brazil +1
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Study Endpoints
Primary Endpoints
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
Month 6

CRR is defined as change in * urine protein creatinine ratio (UPCR) and * estimated glomerular filtration rate (eGFR) and * without use of rescue medication

Secondary Endpoints
Proportion of participants who achieve response according to Definition of Remission in SLE (DORIS) at 6 months post-obe-cel infusion, among all patients who received obe-cel infusion
Month 6
Proportion of participants with CRR.
Up to Month 24
Time to CRR
Up to Month 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Obe-celEXPERIMENTAL -
Interventions
NameTypeDescription
Obecabtagene autoleucelBIOLOGICALObecabtagene autoleucel (obe-cel) given as a single infusion
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Eligibility Criteria
Age Range12 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative * Ability and willingness to adhere to protocol's Schedule of Activities and other requirements * Participants must be 12 t...

Countries:United StatesBrazilUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07053800Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07053800studyFirstPostDate: changed