QEL-005 for Diffuse cutaneous systemic sclerosis | Difficult-to-treat rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Participants must be at least 18 years of age at the time of signing the informed consent."}
• {"criterion_text":"- Specific inclusion criteria for participants with systemic sclerosis (SSc) only 1.\tDiagnosis of diffuse cutaneous systemic sclerosis (dcSSc) as per the 2013 ACR-EULAR criteria. 2.\tSerologically positive for antinuclear antibodies 3.\tFailure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs). 4.\tSkin involvement with a total modified Rodnan Skin Score of at least 15 Evidence of lung fibrosis based on imaging or pulmonary function testing 5.\tEvidence of active disease based on a validated SSc activity assessment"}
• {"criterion_text":"- Up to date vaccination schedule as per local guidance"}
• {"criterion_text":"- Adequate haematological, liver and renal function as assessed by the Investigator according to local laboratory tests"}
• {"criterion_text":"- Willing to undergo annual influenza vaccination"}
• {"criterion_text":"- Willing to enter a 15-year follow-up"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status grade < 3"}
• {"criterion_text":"- Able and willing to use a highly effective method of contraception"}
• {"criterion_text":"- Stable dose of steroid prior to screening"}
• {"criterion_text":"- Specific inclusion criteria for participants with difficult to treat rheumatoid arthritis (D2TRA) only: 1.\tDiagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria 2.\tDiagnosis of D2TRA per 2021 EULAR criteria 3.\tEvidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA. 4.\tEvidence of inflammation in target joints used for the DAS28 CRP assessment"}

Exclusion criteria

• {"criterion_text":"- Presence of a significant medical condition(s), or clinically significant laboratory abnormality, that, in the Investigator's opinion, may impact participant safety or the participant’s ability to undergo study procedures."}
• {"criterion_text":"- History or concern of autoimmune diseases other than those under study"}
• {"criterion_text":"- Active infection, or recurrent chronic infection requiring intervention"}
• {"criterion_text":"- Immunodeficiency or receiving immunoglobulin replacement therapy"}
• {"criterion_text":"- Past or current infection with Hepatitis B or C, tuberculosis (TB), syphilis or HIV."}
• {"criterion_text":"- Participants with clinically significant cardiac dysfunction or pulmonary disease"}
• {"criterion_text":"- History of malignancy within the past 5 years"}
• {"criterion_text":"- Receiving prohibited medications that cannot be stopped at screening"}

Primary endpoints

• {"endpoint_text":"- Dose escalation part: Incidence of protocol-defined dose-limiting toxicities (DLTs) within 14 days postinfusion; Treatment-emergent SAEs, adverse events (AEs) and AEs of Special Interest (AESIs); Clinically significant changes in safety laboratory assessments, ECG and vital signs.","definition_or_measurement_approach":"DLTs assessed within 14 days post-infusion; monitoring and reporting of treatment-emergent SAEs/AEs/AESIs; safety labs, ECG and vital signs assessed for clinically significant changes."}
• {"endpoint_text":"- Expansion part: Treatment-emergent serious adverse events (SAEs), adverse events (AEs) and AEs of Special Interest (AESIs); Clinically significant changes in safety laboratory assessments, electrocardiogram (ECG) and vital signs.","definition_or_measurement_approach":"Monitoring and reporting of treatment-emergent SAEs/AEs/AESIs; assessment of safety laboratory parameters, ECG and vital signs for clinically significant changes."}

Methods

• Website (patient-facing recruitment material) — country-specific materials present for Spain and Germany (website pages and website animations).
• Posters (patient-facing recruitment posters) — country-specific posters for Spain and Germany.
• Website animations and accompanying scripts/storyboards (digital multimedia recruitment content) — available for Spain and Germany.
• Recruitment arrangements documents (country-specific K1 recruitment arrangements) — Spain and Germany.
• Patient concierge / expenses reimbursements provided by Greenphire LLC (support for participants' travel/expenses).

Spain

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

33

Number Of Sites

1

Number Of Participants

4

Germany

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

30

Number Of Sites

3

Number Of Participants

4

Primary sponsor

Full Name

Quell Therapeutics Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

CTI Clinical Trial and Consulting Services Europe GmbH

Responsibilities

codes: 1,10,12,13,2,5,6,7

Name

Cti Clinical Trial Services Inc.

Responsibilities

code: 8

Third parties

• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient concierge/expenses reimbursements","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"France","full_name":"Genosafe S.A.S.","duties_or_roles":"Replication Competent Lentivirus (RCL) testing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cti Clinical Trial Services Inc.","duties_or_roles":"code: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"CTI Clinical Trial and Consulting Services Europe GmbH","duties_or_roles":"codes: 1,10,12,13,2,5,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"The John Radcliffe Hospital","duties_or_roles":"Laboratory analysis - exploratory endpoints","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}