Controlling Hyperactive Immunity With Long-lived Lymphocytes

Recruiting now · Phase 1/Phase 2

Conditions studied: Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Autoimmune Rheumatologic Disease

In brief

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.

Key facts

Study ID

NCT07473154

Run by

Quell Therapeutics Limited

People needed

16

Starts

2026-04-10

Expected to finish

2028-08-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Clinically significant cardiac dysfunction or severe pulmonary impairment
• 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
• History of malignancy in the past 5 years
• Receiving prohibited medication that cannot be stopped at screening

Where it is running

• University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (enrolling)
• Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (enrolling)
• Newcastle Upon Tyne NHS Foundation Trust — Newcastle, United Kingdom (enrolling)
• University of Oxford - The Kennedy Institute — Oxford, United Kingdom (enrolling)
• Guy's & St Thomas NHS Foundation Trust — London, United Kingdom
• Royal Free London NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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