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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (4 UK sites)
Addenbrookes Hospital
Cambridge CB2 0QQ, United Kingdom
University College London Hospitals NHS Foundation Trust
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Great Ormond Street Hospital
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Manchester Royal Infirmary, Manchester University NHS Foundation Trust,
Manchester M13 9WL, United Kingdom
