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Obecabtagene autoleucel

Phase 2

Lupus Nephritis | Monoclonal antibody | Nephrology |Autolus Therapeutics plc|Last Updated: Aug 24, 2026

Target and mechanism

Molecular targetCD19
Target classBinding Agent
ModalityMonoclonal antibody

Also known as Obecabtagene autoleucel (obe-cel)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
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 (SLE) With Active Lupus Nephritis (LN)Lupus Nephritis
RECRUITING35 Analytics
PHASE2RECRUITING
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Lupus NephritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants who achieve complete renal response (CRR)
Month 6

CRR is a composite endpoint

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 achieving remission per Definition of Remission in SLE (DORIS) criteria
Month 6
Proportion of participants achieving CRR over time
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 Sites15

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 StatesBrazilGreeceUnited KingdomVietnamSpain
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Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT07053800lastUpdatePostDate: changed
LOWAug 24, 2026NCT07053800lastUpdatePostDate: changed
LOWAug 1, 2026NCT07053800lastUpdatePostDate: changed
MEDIUMAug 1, 2026NCT06333483Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWAug 1, 2026NCT07053800lastUpdatePostDate: changed
MEDIUMAug 1, 2026NCT06333483Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWAug 1, 2026NCT07053800lastUpdatePostDate: changed
MEDIUMAug 1, 2026NCT06333483Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Obecabtagene autoleucel

What is Obecabtagene autoleucel used for?

Obecabtagene autoleucel, also known as obe-cel, is an investigational therapy being studied for systemic lupus erythematosus, progressive multiple sclerosis, and lupus nephritis. It is a CD19-targeting binding agent under development by Autolus Therapeutics plc (AUTL) for these autoimmune and neurologic conditions.

What does Obecabtagene autoleucel target?

Obecabtagene autoleucel targets CD19, a protein found on B cells. By binding to CD19, the therapy is designed to deplete B cells involved in autoimmune diseases. This mechanism is being evaluated in clinical trials for systemic lupus erythematosus, lupus nephritis, and progressive multiple sclerosis.

Who makes Obecabtagene autoleucel?

Obecabtagene autoleucel is developed by Autolus Therapeutics plc, a biopharmaceutical company traded on the NASDAQ under the ticker AUTL. The company is conducting clinical trials of obe-cel in multiple countries for severe autoimmune and neurologic conditions.

What phase is Obecabtagene autoleucel in?

Obecabtagene autoleucel is in Phase 2 clinical development for lupus nephritis, with an active Phase 1 trial in systemic lupus erythematosus and another Phase 1 trial in progressive multiple sclerosis. It is investigational and not yet approved by regulatory authorities.

What clinical trials is Obecabtagene autoleucel in?

Obecabtagene autoleucel is being studied in three trials: NCT06333483 in systemic lupus erythematosus (Phase 1, active not recruiting), NCT07053800 in lupus nephritis (Phase 2, recruiting), and NCT07139743 in progressive multiple sclerosis (Phase 1, recruiting). These trials are open in the US, UK, Spain, Brazil, Greece, and Vietnam.

Is Obecabtagene autoleucel the same as obe-cel?

Yes, Obecabtagene autoleucel is also known as obe-cel. The shorter name is used in clinical trial titles and medical literature. Both names refer to the same investigational CD19-targeting therapy developed by Autolus Therapeutics.