QEL-005 cell therapy for systemic sclerosis and hard-to-treat rheumatoid arthritis
Tests QEL-005, made from a person's own cells, in adults with these autoimmune diseases.
Key facts
- Who runs it
- Quell Therapeutics Limited
- Where
- Birmingham, Leeds, London, Manchester, Newcastle, and Oxford, United KingdomSee the 7 sitesAlso in 2 other countries, 3 sites
- Trial code
- Registry title
- Controlling Hyperactive Immunity With Long-lived Lymphocytes
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 16 people, planned
- Started
- 10 Apr 2026
- Expected to end
- Aug 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- QEL-005
- Record updated
- 19 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diffuse cutaneous systemic sclerosis or difficult-to-treat rheumatoid arthritis. They would get QEL-005, made from their own immune cells.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Rheumatoid arthritis group: difficult-to-treat rheumatoid arthritis with active disease and inflamed target joints. Systemic sclerosis group: diffuse cutaneous disease with a skin score of at least 15, lung fibrosis and active disease.
- Earlier treatment
- Systemic sclerosis group: did not respond enough to immune-modifying disease-modifying anti-rheumatic drugs (DMARDs). All: stable steroid dose before screening and up-to-date vaccinations. People who had a previous cell therapy cannot join.
- Biomarker or test result
- Systemic sclerosis group: positive antinuclear antibodies.
Main reasons for not taking part
- Past or current hepatitis B or C, tuberculosis, syphilis or HIV
- Any solid organ, bone marrow or stem cell transplant
- Previous cell therapy
- Cancer in the past 5 years
- Autoimmune disease other than the ones studied
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- Participants must be at least 18 years of age at the time of signing the informed consent
- Up to date vaccination status and no planned vaccinations for post 3 months infusion
- Adequate haematological, liver and renal function
- Willing to undergo annual influenza vaccination
- Willing to enter a 15-year follow-up
- Eastern Cooperative Oncology Group (ECOG) performance status grade < 3
- Able and willing to use a highly effective method of contraception
- Stable dose of steroid prior to screening; Specific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only:
- Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria
- Diagnosis of D2TRA per 2021 EULAR criteria
- Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA
- Evidence of inflammation in target joints used for the DAS28 CRP assessment; Specific inclusion criteria for participants with diffuse cutaneous systemic sclerosis (dcSSc) only:
- Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria
- Serologically positive for antinuclear antibodies
- Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs)
- Skin involvement with a total modified Rodnan Skin Score of at least 15
- Evidence of lung fibrosis based on imaging or pulmonary function testing
- Evidence of active disease based on a validated SSc activity assessment
Who cannot take part
- Immunodeficiency or receiving immunoglobulin replacement therapy
- Use of investigational agents within a pre-defined period prior to study screening
- Received a previous cell therapy
- Received certain B cell related experimental therapies in a clinical trial with the past year
- Any solid organ, bone marrow or stem cell transplant
- Receiving prohibited medication that cannot be stopped at screening
- History or concern of autoimmune diseases other than those under study
- Active infection, or recurrent chronic infection requiring intervention
- Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV
- Clinically significant cardiac dysfunction or severe pulmonary impairment
- History of malignancy in the past 5 years
- Presence of a significant medical condition(s), or clinically significant laboratory abnormality
Where in United Kingdom
Also in 2 other countries, 3 sites
- University Hospitals Birmingham NHS Foundation TrustBirmingham, United KingdomContact: Benjamin FisherTaking people
- Leeds Teaching Hospitals NHS TrustLeeds, United KingdomContact: Francesco Del GadoTaking people
- Guy's & St Thomas' NHS Foundation TrustLondon, United KingdomContact: Andrew CopeNot yet recruiting
- Royal Free London NHS Foundation TrustLondon, United KingdomContact: Voon OngTaking people
- Manchester University NHS Foundation TrustManchester, United KingdomContact: Maya BuchNot yet recruiting
- Newcastle Upon Tyne NHS Foundation TrustNewcastle, United KingdomContact: John IsaacsTaking people
- University of Oxford - The Kennedy InstituteOxford, United KingdomContact: Chris BuckleyTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Dose EscalationTreatment being tested
Dose escalation will involve 3 distinct dose level ranges. Each dose level will enrol at least 3 participants
Treatment: QEL-005
- Dose ExpansionTreatment being tested
The dose selected for dose expansion will be based on safety and any relevant additional data emerging from the Dose Escalation phase
Treatment: QEL-005
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase I/II Study of QEL-005 in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) and in Patients With Difficult to Treat Rheumatoid Arthritis (D2TRA).
- Plain-language title
- QEL-005 cell therapy for systemic sclerosis and hard-to-treat rheumatoid arthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 19 October 2026