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Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients With Severe, Refractory Systemic Lupus Erythematosus

NCT06333483•Autolus Limited

View on ClinicalTrials.gov

Summary

This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.

Detailed Description

This is a single-arm, open-label Phase 1 Study to determine the safety, tolerability, and preliminary efficacy of obe-cel in patients with severe, refractory SLE. Up to a maximum of 18 patients will be treated in a maximum of 3 dose levels. By using the Bayesian Optimal Interval (BOIN) design for overdose control, the Sponsor will review the Safety Review Committee (SRC) and Independent Data Monitoring Committee (IDMC) recommendation and determine if a dose level is suitable for a subsequent study.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Women or men ≥ 18 years at screening \[Spain only\] or patients 12 to 65 years of age (inclusive) at the time of signing the informed consent \[UK only\]
•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 one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥ 1:80, or anti-dsDNA (≥ 30 IU/mL) or anti-Smith (\> upper limit of normal \[ULN\]), anti-histone or anti-chromatin (\> ULN)
•Severe, refractory SLE

Exclusion Criteria

•Medications
•* Within 2 months of leukapheresis: use of anti-CD20 therapy
•* Prior treatment with anti-CD19 therapy (including bispecifics), adoptive T cell therapy or any prior gene therapy product (e.g., CAR T cell therapy)
•* Immunization with a live or attenuated vaccine within 2 months of leukapheresis
•SLE and Autoimmunity:
•* Recurrent neuropsychiatric lupus or active, severe or unstable neuropsychiatric lupus within 2 years from screening
•* Diagnosis of drug-induced SLE rather than idiopathic SLE
•* Any acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible; thus, making the patient ineligible for CD19 CAR T therapy as judged by the Investigator or Sponsor
•* 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 patient
•* Diagnosis of another non-SLE autoimmune disease (e.g., dermatomyositis, polymyositis, scleroderma, rheumatoid arthritis) or overlap syndrome
+16 more criteria

Locations (6)

Hospital Universitari Vall Hebrón

Barcelona, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Addenbrookes Hospital

Cambridge, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

Manchester Royal Infirmary, Manchester University NHS Foundation Trust,

Manchester, United Kingdom

Key Dates

Start Date

February 2, 2024

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus Erythematosus

Interventions

Obecabtagene autoleucel (obe-cel)

BIOLOGICAL

Contacts

Autolus Limited

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

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