NCT07053800

Brief Summary

The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
38mo left

Started Jan 2026

Typical duration for phase_2

Geographic Reach
4 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Oct 2029

First Submitted

Initial submission to the registry

May 13, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

May 13, 2025

Last Update Submit

July 30, 2026

Conditions

Lupus Nephritis

Keywords

Systemic lupus erythematosusRefractory systemic lupus erythematosusLupus nephritisObecabtagene autoleucelObe-cel

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants who achieve complete renal response (CRR)

    CRR is a composite endpoint

    Month 6

Secondary Outcomes (13)

  • 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

  • Proportion of participants with Partial Renal Response (PRR)

    Up to Month 24

  • Time to PRR

    Up to Month 24

  • +8 more secondary outcomes

Study Arms (1)

Obe-cel

EXPERIMENTAL
Biological: Obecabtagene autoleucel

Interventions

Obecabtagene autoleucelBIOLOGICAL

Obecabtagene autoleucel (obe-cel) given as a single infusion

Also known as: Obe-cel
Obe-cel

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 to 65 years of age inclusive at the time of signing the informed consent.
  • Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding
  • Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.
  • Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.
  • Severe, Active SLE defined as:
  • SLEDAI-2K score of ≥ 8 points AND
  • Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)
  • Refractory SLE defined as failure to previous lines of therapy

You may not qualify if:

  • Prior treatment at any time with anti-CD19 therapy
  • More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible
  • Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant
  • History of primary antiphospholipid antibody syndrome
  • Active or uncontrolled fungal, bacterial, or viral infection
  • History of malignant neoplasms unless disease free for at least 24 months
  • History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

State University of New York Upstate Medical Center (SUNY)

Syracuse, New York, 13210, United States

RECRUITING

Texas Transplant Institute

San Antonio, Texas, 78229, United States

RECRUITING

Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

RECRUITING

University General Hospital ATTIKON

Athens, 12461, Greece

RECRUITING

University General Hospital of Patras

Pátrai, 26504, Greece

RECRUITING

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

RECRUITING

Bristol Haematology and Oncology Centre

Bristol, BS1 3LH, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Western General Hospital Edinburgh

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

University College Hospital

London, MW1 2PG, United Kingdom

RECRUITING

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

RECRUITING

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lupus NephritisLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Autolus Ltd

CONTACT

+44 (0)203 911 4385clinicaltrials@autolus.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm, single group assignment, open-label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2025

First Posted

July 8, 2025

Study Start

January 16, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

October 1, 2029

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(8)US(3)BR(1)GR(2)