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

NCT06333483 | Recruiting Phase 1 DMC

• 2 other identifiers: AUTO1-SL12023-508236-60-00
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

AUTO1; Obecabtagene autoleucel (obe-cel); CD19-positive chimeric antigen receptor T cell; CAR-T

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities

  Percentage of patients receiving obe-cel who experience dose-limiting toxicities (DLTs)

  Up to 28 days from obe-cel infusion

• Adverse events

  Adverse event (AE) type, frequency, severity, and relationship with obe-cel and lymphodepletion of AEs

  Up to Month 12

Secondary Outcomes (11)

• Remission rate according to Definition of Remission in SLE (DORIS)

  Up to Month 12

• Response over time according to Definition of Remission in SLE (DORIS)

  Up to Month 12

• Time to response according to Definition of Remission in SLE (DORIS)

  Up to Month 12

• Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

  Up to Month 12

• Change over time in Physician's global assessment (PGA)

  Up to Month 12

Study Arms (1)

AUTO1

EXPERIMENTAL

Biological: Obecabtagene autoleucel (obe-cel)

Interventions

Obecabtagene autoleucel (obe-cel) BIOLOGICAL

Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a single dose of obe-cel

AUTO1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Medical History:
• History or presence of: (Within 3 months before screening visit)
• Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, or stroke
• Evidence of deep venous thrombosis or pulmonary embolism
• History or presence of severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis

Sponsors & Collaborators

• Autolus Limited: lead

Study Sites (6)

Hospital Universitari Vall Hebrón

Barcelona, 08035, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 106046026, Spain

RECRUITING

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

RECRUITING

Manchester Royal Infirmary, Manchester University NHS Foundation Trust,

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Autolus Limited

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 27, 2024
• Study Start: February 2, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

GB (4); ES (2)