Actively Recruiting
Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
Led by Autolus Limited · Updated on 2026-02-27
18
Participants Needed
6
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men 12 to 65 years of age (inclusive) at the time of signing informed consent (UK only) or 18 years at screening (Spain only)
- Diagnosis of SLE meeting the 2019 EULAR/ACR Classification Criteria
- Positive for at least one autoantibody: ANA 1:80, anti-dsDNA 30 IU/mL, or anti-Smith, anti-histone, or anti-chromatin above the upper limit of normal
- Severe, refractory SLE
You will not qualify if you...
- Use of anti-CD20 therapy within 2 months before leukapheresis
- Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or gene therapy including CAR T cell therapy
- Immunization with live or attenuated vaccine within 2 months before leukapheresis
- Recurrent or active severe neuropsychiatric lupus within 2 years before screening
- Diagnosis of drug-induced SLE instead of idiopathic SLE
- Acute severe lupus flare during screening needing immediate treatment or preventing immunosuppressive washout
- Significant irreversible organ damage related to SLE making CD19 CAR T therapy unlikely to help
- Diagnosis of another autoimmune disease or overlap syndrome
- Recent clinically relevant CNS pathology (epilepsy, paresis, aphasia, stroke) within 3 months
- History of deep vein thrombosis or pulmonary embolism
- Severe brain injuries, dementia, Parkinson's disease, organic brain syndrome, uncontrolled mental illness, or psychosis
- Uncontrolled heart disease not due to SLE or recent cardiac event within 12 months
- Active or uncontrolled infections requiring systemic antimicrobial treatment
- Active or latent hepatitis B or active hepatitis C
- Positive tests for HIV, HTLV-1, HTLV-2, or syphilis at screening
- History of malignant tumors unless disease free for at least 24 months (some skin and in situ breast cancers allowed)
- History of heart, lung, kidney, liver transplant or stem cell transplant
- Pregnancy or lactation
- Left ventricular ejection fraction below 45% or institute's lower normal limit
- Oxygen saturation below 90% without oxygen support
- Presence of B cell aplasia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hospital Universitari Vall Hebrón
Barcelona, Spain, 08035
Actively Recruiting
2
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 106046026
Actively Recruiting
3
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
4
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
5
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
6
Manchester Royal Infirmary, Manchester University NHS Foundation Trust,
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
A
Autolus Limited
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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