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obe-cel (AUTO1)

Phase 2FDA approved

Lupus Nephritis | Cell therapy | Nephrology |Autolus Therapeutics plc|Trials Updated: Oct 30, 2026

obe-cel (AUTO1) development status

FDA approval on record Approved
Highest phase Phase 2

obe-cel (AUTO1) 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 Trials5
Total Enrollment258

FDA Designations

No designations recorded

obe-cel (AUTO1) clinical trials

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

Phase 2 1Phase 1/2 1Phase 1 3
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

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
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

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 -
AUTO1EXPERIMENTAL -
Obecabtagene autoleucel (obe-cel)EXPERIMENTAL -

Interventions

NameTypeDescription
Obecabtagene autoleucelBIOLOGICALObecabtagene autoleucel (obe-cel) given as a single infusion
AUTO1BIOLOGICALFollowing pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a total target dose of 410E+6 of CD19-positive CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).
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 Sites16

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)

LOWOct 30, 2026NCT07053800lastUpdatePostDate: changed
LOWOct 30, 2026NCT07053800lastUpdatePostDate: changed
LOWOct 16, 2026NCT07139743Enrollment: 18 → 24
LOWOct 16, 2026NCT07139743Enrollment: 18 → 24
LOWOct 9, 2026NCT06173518lastUpdatePostDate: changed
LOWOct 9, 2026NCT06173518lastUpdatePostDate: changed
LOWOct 5, 2026NCT06173518lastUpdatePostDate: changed
LOWOct 5, 2026NCT06173518lastUpdatePostDate: changed
LOWSep 16, 2026NCT06173518lastUpdatePostDate: changed
LOWSep 16, 2026NCT06173518lastUpdatePostDate: changed
LOWAug 24, 2026NCT07053800lastUpdatePostDate: changed
LOWAug 24, 2026NCT07053800lastUpdatePostDate: changed

Frequently asked questions about obe-cel (AUTO1)

What is obe-cel (AUTO1)?

Obe-cel is an investigational CD19-targeted CAR T cell therapy developed by Autolus Therapeutics plc (ticker AUTL). It is being studied in B cell acute lymphoblastic leukemia and in autoimmune conditions including systemic lupus erythematosus, lupus nephritis, and progressive multiple sclerosis. It is also known as obecabtagene autoleucel, or AUTO1.

What does obe-cel target?

Obe-cel targets CD19, a B cell surface protein. Because CD19 is expressed on B cells, the therapy is directed at B cell populations in both hematologic malignancies such as B cell acute lymphoblastic leukemia and in autoimmune diseases where B cells contribute to disease activity, including lupus nephritis and systemic lupus erythematosus.

Who is developing obe-cel?

Obe-cel is being developed by Autolus Therapeutics plc, which trades under the ticker AUTL. The company is running clinical programs for obecabtagene autoleucel across relapsed or refractory B cell acute lymphoblastic leukemia and several autoimmune indications, including systemic lupus erythematosus, lupus nephritis, and progressive multiple sclerosis.

What phase is obe-cel in?

Obe-cel is investigational and in clinical development. Its lupus nephritis program is in Phase 2, while studies in progressive multiple sclerosis, systemic lupus erythematosus, and pediatric relapsed or refractory B cell acute lymphoblastic leukemia are Phase 1. Obe-cel has not been established as approved for these uses in the trials described here.

What clinical trials is obe-cel in?

Obe-cel trials include NCT07053800, a Phase 2 study in severe refractory systemic lupus erythematosus with active lupus nephritis, and NCT07139743, a Phase 1 study in refractory progressive multiple sclerosis. Phase 1 studies also include 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?

Yes. Obe-cel is the short name for obecabtagene autoleucel, which is also referred to by the code AUTO1. All three names refer to the same CD19-targeted CAR T cell therapy developed by Autolus Therapeutics plc (ticker AUTL) and studied across B cell acute lymphoblastic leukemia and autoimmune indications.