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ACTIVE NOT RECRUITINGPhase1

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

Sponsor: Autolus Limited

NCT ID: NCT06333483

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Obecabtagene autoleucel (obe-cel) (biological)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
Obecabtagene autoleucel (obe-cel) — biological: Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a single dose of obe-cel
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
16
Started
2024-02-02
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic lupus erythematosus
  • • Phase1 - 16 participants
  • • 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

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with systemic lupus erythematosus

Where?

  • • Cambridge - Addenbrookes Hospital
  • • London - University College London Hospitals NHS Foundation Trust
  • • London - Great Ormond Street Hospital
  • • Manchester - Manchester Royal Infirmary, Manchester University NHS Foundation Trust,

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Systemic Lupus Erythematosus

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD20CD19syphilis positive

What the study is looking for

  • ✓Key Inclusion Criteria-
  • ✓Women or men ≥ 18 years at screening \[Spain only\] or patients 12 to 65 years of age (inclusive) at the time of...
  • ✓Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology...
  • ✓Severe, refractory SLE

Who cannot take part

  • ✗Key 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...
  • ✗Immunization with a live or attenuated vaccine within 2 months of leukapheresis
See the full criteria
Inclusion Criteria: -Key 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: -Key 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 * 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 * Clinically significant, uncontrolled heart disease not due to SLE (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmia, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless the patient has a pacemaker) or a recent (within 12 months of screening) cardiac event * Active or uncontrolled fungal, bacterial, viral (including COVID-19), or other infection requiring systemic antimicrobials for management * Active or latent hepatitis B or active hepatitis C * Human immunodeficiency virus, human T-cell leukemia virus (HTLV)-1, HTLV-2 or syphilis positive test at screening * History of malignant neoplasms unless disease free for at least 24 months (basal cell or squamous cell carcinoma in situ, or in situ breast cancer on hormonal therapy allowed) * History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant * Pregnancy or lactating * Laboratory and Organ Function: * Left ventricular ejection fraction \< 45% (or \< institute's lower limit of normal) confirmed by echocardiogram * Oxygen saturation (SpO2) \< 90% in the absence of oxygen support * B cell aplasia

Where Is This Study? (4 UK sites)

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

University College London Hospitals NHS Foundation Trust

London NW1 2PG, United Kingdom

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Great Ormond Street Hospital

London WC1N 3JH, United Kingdom

Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

Manchester Royal Infirmary, Manchester University NHS Foundation Trust,

Manchester M13 9WL, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340
Data sourced from ClinicalTrials.gov · Last verified: 2026-07