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
- QEL-005 (drug)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- QEL-005 — drug: QEL-005 is an autologous cell therapy that is composed of engineered regulatory T cells transduced with a lentiviral vector containing a CAR directed against the B cell marker CD19.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at using long-lived lymphocytes (a type of white blood cell) to control an overactive immune system in people with diffuse cutaneous systemic sclerosis (a form of the condition where skin thickening affects large areas of the body) or difficult-to-treat rheumatoid arthritis. It is run by Quell Therapeutics Limited. Details of exactly what treatment participants receive are not stated — ask the trial team.
Who can take part
- Adults aged 18 or over
- Up to date with vaccinations, with none planned for 3 months after the infusion
- Healthy enough blood, liver and kidney function
- Willing to have the yearly flu jab
- Willing to be followed up for 15 years
- Able to carry out day-to-day activities (performance status below grade 3)
- Able and willing to use highly effective contraception
- On a stable dose of steroid before screening
- For rheumatoid arthritis: a diagnosis of rheumatoid arthritis and of difficult-to-treat disease, with active disease and inflamed joints
- For diffuse cutaneous systemic sclerosis: a diagnosis of the condition, positive antinuclear antibodies, not responded well enough to standard disease-modifying medicines, skin involvement score of at least 15, lung fibrosis on scans or breathing tests, and active disease
Who may not be able to
- Other serious medical conditions or abnormal test results
- Other autoimmune diseases
- Current or long-term infections needing treatment
- Weakened immune system or receiving antibody replacement therapy
- Past or current hepatitis B or C, tuberculosis, syphilis or HIV
- Serious heart problems or severe lung problems
- Recent use of experimental medicines
- Previous cell therapy
- Certain experimental B cell treatments in the past year
- Any organ, bone marrow or stem cell transplant
- Cancer in the past 5 years
- Taking medicines that are not allowed and cannot be stopped
What taking part involves
- • A one-off infusion of long-lived lymphocytes (a type of immune cell)
- • Yearly flu vaccination
- • Follow-up for 15 years
Time commitment: Taking part involves an infusion, annual flu jabs, and being followed up for 15 years; the number of visits is not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 16
- Started
- 2026-04-10
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for diffuse cutaneous systemic sclerosis
- • Phase1/Phase2 - 16 participants
- • This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with diffuse cutaneous systemic sclerosis
Where?
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust
- • Leeds - Leeds Teaching Hospitals NHS Trust
- • London - Guy's & St Thomas NHS Foundation Trust
- • London - Royal Free London NHS Foundation Trust
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms. QEL-005 is made from a participant's own white blood cells (autologous cells). These cells are collected and then changed in a laboratory using genetic methods to create specialized immune cells called CAR-T regulatory cells that target a protein on B cells called CD19. These modified cells are then given back to the participant by intravenous (IV) infusion. To take part, eligible participants will first have a procedure called leukapheresis, where some of their white blood cells are removed from the blood. The study team will use these cells to manufacture QEL005. After QEL005 is ready, participants will receive an IV infusion of their modified cells, stay in hospital overnight for monitoring, and will then be followed closely in the clinic. Throughout the trial, participants will have regular safety checks, which may include blood tests, imaging scans, questionnaires about symptoms and daily functioning, and biopsies taken from involved tissues, to help understand how QEL005 is working in the body. Detailed follow up will be for 1 year after QEL-005 infusion, and there is long-term follow up for a total of 15 years, which is standard for cell therapies. The information from this Phase 1/2 study will help determine an appropriate dose and dosing schedule of QEL005 for future studies.
More detail
This is a single-arm, open label, multicentre, Phase 1/2, first in human study of QEL005 in adult participants with diffuse cutaneous systemic sclerosis (dcSSc) or difficult to treat rheumatoid arthritis (D2TRA). QEL005 is an autologous chimeric antigen receptor regulatory T-cell (CAR-Treg) therapy directed against the CD19 marker found on B cells. The primary objective of this study is to evaluate the safety and tolerability of single IV infusions of QEL005 across different dose levels in participants with dcSSc or D2TRA. Secondary and exploratory objectives include assessment of preliminary clinical efficacy (for example, changes in disease activity scores, skin involvement, or joint symptoms, as appropriate for each disease) and evaluation of biological activity (including effects on B cell populations, immune biomarkers, and other laboratory measures). The study uses a dose escalation phase then a dose expansion phase. In the dose escalation phase, sequential cohorts of participants receive increasing doses of QEL005 under close safety monitoring. Safety assessments include recording of adverse events, vital signs and laboratory abnormalities. QEL005 is manufactured from autologous leukapheresis material obtained at baseline. Participants undergo leukapheresis for collection of peripheral blood mononuclear cells, which are then genetically modified ex vivo to express a CD19directed CAR-T regulatory cell. Over the course of the trial, participants will attend scheduled visits for clinical evaluations, laboratory tests, imaging studies, and patient reported outcome questionnaires, as well as tissue biopsies, to characterize the safety profile and to explore pharmacodynamic and immunologic effects of QEL005. There are detailed assessments over the first year following QEL-005 infusion, and then additional long-term follow up for 15 years, standard for cell therapy trials. Data from this Phase 1/2 trial will inform the recommended dose, regimen, and patient population for subsequent studies of QEL005 in autoimmune diseases.
How this trial compares with your answers
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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: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participants must be at least 18 years of age at the time of signing the agreement to take part.
- ✓Up to date vaccination status and no planned vaccinations for post 3 months infusion
- ✓Adequate haematological, liver and kidney function
- ✓Willing to undergo annual influenza vaccination
- ✓Willing to enter a 15-year follow-up
Who cannot take part
- ✗Presence of a significant medical condition(s), or clinically significant laboratory abnormality
- ✗History or concern of autoimmune diseases other than those under study
- ✗Active infection, or recurrent chronic infection requiring intervention
- ✗Immunodeficiency or receiving immunoglobulin replacement therapy
- ✗Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV
See the full criteria
Where Is This Study? (7 UK sites)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Guy's & St Thomas NHS Foundation Trust
London, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Newcastle Upon Tyne NHS Foundation Trust
Newcastle, United Kingdom
University of Oxford - The Kennedy Institute
Oxford, United Kingdom
How to Get in Touch
Quell Therapeutics Clinical Trials
Sponsor contactCONTACT