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obe-cel (AUTO1)

Phase 2

Lupus Nephritis | Cell therapy | Nephrology |Autolus Therapeutics plc|Last Updated: Sep 16, 2026

Target and mechanism

Molecular targetCD19
Target classBinding Agent
ModalityCell therapy

Also known as Obecabtagene autoleucel (obe-cel), Obecabtagene autoleucel, AUTO1

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

obe-cel (AUTO1) · 5 trials · 5 indications

Phase 2 1Phase 1 4
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

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Up to 24 months
Incidence and duration of severe hypogammaglobulinemia
Up to 24 months
Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment
3 months
Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
Up to 24 months
Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.
Up to 24 months

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.
AUTO1BIOLOGICALFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells
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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)

LOWSep 16, 2026NCT06173518lastUpdatePostDate: changed
LOWSep 16, 2026NCT06173518lastUpdatePostDate: changed
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 obe-cel (AUTO1)

What is obe-cel (AUTO1) used for?

Obe-cel is an investigational cell therapy being studied in several conditions: lupus nephritis, systemic lupus erythematosus, progressive multiple sclerosis, and relapsed or refractory B cell acute lymphoblastic leukemia. It is also being evaluated in aggressive mature B-cell non-Hodgkin lymphoma. All of these uses remain in clinical development rather than routine clinical practice.

What does obe-cel (AUTO1) target?

Obe-cel targets CD19, a protein found on the surface of B cells. It is a CD19-directed chimeric antigen receptor T cell therapy, meaning the patient's T cells are engineered to recognize and act on CD19-expressing cells. This binding-agent approach underlies its study in both B cell malignancies and B cell driven autoimmune conditions.

Who makes obe-cel (AUTO1)?

Obe-cel is developed by Autolus Therapeutics plc, which trades on the Nasdaq under the ticker AUTL. The company is the sponsor behind the clinical programs evaluating the therapy across autoimmune and hematologic indications.

What phase is obe-cel (AUTO1) in?

Obe-cel is in Phase 2 development overall and is investigational, meaning it has not been established as an approved therapy. Its programs span Phase 1 and Phase 2 studies, with the Phase 2 work focused on severe, refractory systemic lupus erythematosus with active lupus nephritis.

What clinical trials is obe-cel (AUTO1) in?

Obe-cel is being studied in trials including NCT07053800 in severe refractory systemic lupus erythematosus with active lupus nephritis, NCT07139743 in refractory progressive forms of multiple sclerosis, NCT06333483 in severe refractory systemic lupus erythematosus, and NCT06173518 in pediatric relapsed or refractory B cell acute lymphoblastic leukemia and aggressive mature B-cell non-Hodgkin lymphoma.

Is obe-cel the same as obecabtagene autoleucel or AUTO1?

Yes. Obe-cel, obecabtagene autoleucel, and AUTO1 all refer to the same investigational CD19-directed CAR T cell therapy from Autolus Therapeutics. Readers may encounter any of these names in trial listings, publications, or company materials, and they describe the same asset.