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Obecabtagene autoleucel

Phase 2

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

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical trial landscape

Obecabtagene autoleucel · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT07053800Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus NephritisLupus Nephritis
RECRUITING35 Analytics
PHASE2RECRUITING
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
Lupus NephritisUnlock trial analytics
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

Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs))
Up to Day 28
To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)
Up to end of study
Dose-limiting toxicities
Up to 28 days from obe-cel infusion

Percentage of patients receiving obe-cel who experience dose-limiting toxicities (DLTs)

Adverse events
Up to Month 12

Adverse event (AE) type, frequency, severity, and relationship with obe-cel and lymphodepletion of AEs

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 -
Obecabtagene autoleucel (obe-cel)EXPERIMENTAL -
AUTO1EXPERIMENTAL -
Interventions
NameTypeDescription
Obecabtagene autoleucelBIOLOGICALObecabtagene autoleucel (obe-cel) given as a single infusion
Obecabtagene autoleucel (obe-cel)BIOLOGICALObecabtagene autoleucel (obe-cel) given as a single infusion.
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Eligibility Criteria
Age Range12 Years to 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 KingdomSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06333483primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT07053800Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMMay 26, 2026NCT07139743primaryCompletionDate: changed
LOWMay 24, 2026NCT06333483studyFirstPostDate: changed
LOWMay 24, 2026NCT07139743studyFirstPostDate: changed
LOWMay 24, 2026NCT07053800studyFirstPostDate: changed