Actively Recruiting
Phase I/II Study of QEL-005 in Adults With Diffuse Cutaneous Systemic Sclerosis and Difficult-to-Treat Rheumatoid Arthritis
Led by Quell Therapeutics Limited · Updated on 2026-05-11
16
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental treatment called QEL-005 in adults with two autoimmune diseases: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). This Phase 1/2 open-label study aims to assess the safety, tolerability, and potential effects of QEL-005 on disease activity and symptoms. QEL-005 is made from the participant's own white blood cells, which are genetically modified to create specialized immune cells targeting B cells. The treatment involves collecting white blood cells through leukapheresis and modifying them in a lab to produce CAR-T regulatory cells directed against the CD19 protein on B cells. Participants then receive a single intravenous infusion of these modified cells. The study includes a dose escalation phase with increasing doses to assess safety, followed by a dose expansion phase using the selected dose. After infusion, participants stay overnight in the hospital for monitoring. Participants will have regular safety checks including blood tests, imaging scans, symptom questionnaires, and tissue biopsies to evaluate how QEL-005 works. Follow-up visits occur over one year after infusion with detailed assessments, plus a long-term safety follow-up extending to 15 years, which is standard for cell therapies. The study will help determine the appropriate dose and treatment schedule for future research.
CONDITIONS
Brief Title
Controlling Hyperactive Immunity With Long-lived Lymphocytes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old at the time of informed consent
- Up to date vaccination status and no planned vaccinations for 3 months after infusion
- Adequate blood, liver, and kidney function
- Willing to receive annual influenza vaccination
- Willing to participate in a 15-year follow-up
- Eastern Cooperative Oncology Group performance status less than grade 3
- Able and willing to use a highly effective method of contraception
- Stable steroid dose before screening
- For difficult-to-treat rheumatoid arthritis participants: diagnosis per 2010 ACR-EULAR criteria and 2021 EULAR criteria, active disease with inflammation in target joints
- For diffuse cutaneous systemic sclerosis participants: diagnosis per 2013 ACR-EULAR criteria, positive antinuclear antibodies, insufficient response to immunomodulatory drugs, skin involvement with modified Rodnan Skin Score of at least 15, lung fibrosis evidence, and active disease based on validated assessment
You will not qualify if you...
- Significant medical conditions or abnormal lab results
- History or concern of autoimmune diseases other than study conditions
- Active or recurrent infections needing treatment
- Immunodeficiency or immunoglobulin replacement therapy
- Past or current hepatitis B or C, tuberculosis, syphilis, or HIV infection
- Significant heart or severe lung problems
- Use of investigational agents shortly before screening
- Previous cell therapy
- B cell experimental therapies within the past year
- Any solid organ, bone marrow, or stem cell transplant
- History of cancer in the past 5 years
- Use of prohibited medications that cannot be stopped before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline to day of infusion
Participants undergo leukapheresis for collection of peripheral blood mononuclear cells, which are then genetically modified ex vivo to prepare the QEL-005 therapy.
1 to 2 visits depending on procedures
Duration - Single day infusion with assessments up to 28 days post-infusion for dose escalation phase
Participants receive a single intravenous infusion of QEL-005, an autologous CAR-T regulatory cell therapy targeting B cells, with dose escalation or expansion depending on cohort assignment.
1 infusion visit and multiple safety monitoring visits up to 28 days
Duration - Up to 52 weeks
Participants attend scheduled visits for clinical evaluations, laboratory tests, imaging studies, and patient reported outcome questionnaires to monitor safety, clinical efficacy, and biological activity for 52 weeks following infusion.
Multiple visits including assessments at weeks 4, 8, 12, 24, 38, and 52
Duration - Up to 15 years
Participants are followed for long-term safety and clinical outcomes for 15 years after infusion as standard for cell therapy trials.
Annual visits
Trial Site Locations
Total: 6 locations
1
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Not Yet Recruiting
2
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Actively Recruiting
3
Guy's & St Thomas NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
4
Royal Free London NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
5
Newcastle Upon Tyne NHS Foundation Trust
Newcastle, United Kingdom
Actively Recruiting
6
University of Oxford - The Kennedy Institute
Oxford, United Kingdom
Actively Recruiting
Research Team
Q
Quell Therapeutics Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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