Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythem… (NCT06333483) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
Spain, United Kingdom16 participantsStarted 2024-02-02
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
Key Inclusion Criteria-
Exclusion criteria
Key Exclusion Criteria-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is a Phase 1 study primarily measuring dose-limiting toxicities and adverse events in severe, refractory lupus — what does that mean for what's currently known about the safety of obe-cel in lupus patients, and is that level of uncertainty appropriate for my situation?
2Since the trial is listed as 'active not recruiting,' does that mean enrollment is closed, and if so, are there any similar CAR-T or experimental trials for refractory lupus that I might still be eligible for?
3Obe-cel is a CAR-T cell therapy, which typically involves a complex process like lymphodepletion and hospital monitoring — given my current health and support situation, is my body and lifestyle realistically able to handle that kind of intensive treatment?
4My lupus is described as 'severe and refractory' to qualify for this trial — before considering something this experimental, have we truly exhausted all approved or standard treatment options, and what would those look like for me?
5If I had been a candidate for this trial, how would my existing organ damage or current medications have affected my eligibility, and does that tell us anything useful about which treatments might work best for me now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.