Using long-lived immune cells to calm an overactive immune system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

QEL-005 is made from a participant's own white blood cells collected by leukapheresis, genetically modified ex vivo to express a CD19-targeted regulatory receptor, and returned by intravenous infusion. This open-label Phase 1/2, single-arm study uses a dose-escalation followed by dose-expansion design to characterize safety and tolerability and to collect preliminary clinical and biological activity data. Safety monitoring includes adverse event recording, laboratory tests, and vital signs, and secondary assessments will track disease-specific outcome measures and immune biomarkers. Participants will be followed long-term, including a planned 15-year follow-up for durability and late safety signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• University Hospital Düsseldorf
  Düsseldorf, Germany Recruiting
• Hospital Universitario Fundacion Jimenez Diaz
  Madrid, Spain Recruiting
• University Hospitals Birmingham NHS Foundation Trust
  Birmingham, United Kingdom Recruiting
• Leeds Teaching Hospitals NHS Trust
  Leeds, United Kingdom Recruiting
• Royal Free London NHS Foundation Trust
  London, United Kingdom Recruiting
• Newcastle Upon Tyne NHS Foundation Trust
  Newcastle, United Kingdom Recruiting

Study contacts

• Study coordinator: Quell Therapeutics Clinical Trials
• Email: contact@quell-tx.com
• Phone: +44(0)2070969012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.