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
- CC-97540 (drug), Fludarabine (drug), Cyclophosphamide (drug)
- How long the study runs
- Study runs about 83 months (dates as stated)
- About the drug or intervention
- CC-97540 — drug: Specified dose on specified days · Fludarabine — drug: Specified dose on specified days · Cyclophosphamide — drug: Specified dose on specified days
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 89
- Started
- 2025-07-14
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for lupus erythematosus, systemic
- • Phase2 - 89 participants
- • The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with lupus erythematosus, systemic
Where?
- • London - University College London Hospital
- • London - King's College Hospital
- • Metropolitan Borough of Wirral - Local Institution - 0090
- • Crownhill, Plymouth - Derriford Hospital, University Hospitals Plymouth NHS Trust
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
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: 16 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ active disease when signing ICF
Treatments you must NOT have had:
- ✗ live vaccines
What the study is looking for
- ✓Participants must meet EULAR/ACR 2019 criteria for SLE.
- ✓Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant...
- ✓Participants must have active disease when signing ICF.
Who cannot take part
- ✗Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects...
- ✗IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.
- ✗Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell...
- ✗Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting drug treatment)...
- ✗Participant must not have inhealthy organ.
See the full criteria
Where Is This Study? (5 UK sites)
University College London Hospital
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825King's College Hospital
London SE5 9RL, United Kingdom
Local Institution - 0090
Metropolitan Borough of Wirral L63 4JY, United Kingdom
Derriford Hospital, University Hospitals Plymouth NHS Trust
Crownhill, Plymouth PL6 8DH, United Kingdom
Local Institution - 0091
Liverpool L9 7AL, United Kingdom