Study QEL-005-CLN-01. 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).
Key facts
- Where
- Duesseldorf, Erlangen és Magdeburg, NémetországSee the 3 sites
- Phase
- 1/2. fázis
Where in Németország
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, NémetországTaking people
- Universitaetsklinikum Erlangen AöRErlangen, NémetországTaking people
- Otto Von Guericke Universitaet MagdeburgMagdeburg, NémetországTaking people
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?
Trial details
- Who runs it
- Quell Therapeutics Limited
- Trial code
- EU 2025-523971-46-00
- Record updated
- 2026. október 15.
- Original description
To determine the safety and tolerability of a single dose of QEL-005.Read full original descriptionShow less
A single-arm, open-label, multi-centre, phase I/II first-in-human study evaluating the safety and clinical activity of QEL-005, an autologous CAR T-regulatory cell therapy treatment targeting CD19, in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA).
To determine the safety and tolerability of a single dose of QEL-005.
Inclusion: Participants must be at least 18 years of age at the time of signing the informed consent; Specific inclusion criteria for participants with systemic sclerosis (SSc) only 1. Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) as per the 2013 ACR-EULAR criteria. 2. Serologically positive for antinuclear antibodies 3. Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs). 4. Skin involvement with a total modified Rodnan Skin Score of at least 15 5. Evidence of lung fibrosis based on imaging or pulmonary function testing 6. Evidence of active disease based on a validated SSc activity assessment; Up to date vaccination schedule as per local guidance; Adequate haematological, liver and renal function as assessed by the Investigator according to local laboratory tests; 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; Participants requiring oral steroids be on a stable dose of steroid prior to screening; Specific inclusion criteria for participants with difficult to treat rheumatoid arthritis (D2TRA) only: 1. Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria 2. Diagnosis of D2TRA per 2021 EULAR criteria 3. Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA. 4. Evidence of inflammation in target joints used for the DAS28 CRP assessment.
Exclusion: Immunodeficiency or receiving immunoglobulin replacement therapy; Receiving prohibited medications that cannot be stopped at screening; Active 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 (TB), syphilis or HIV; Participants with known clinically significant cardiac dysfunction or pulmonary disease; History of malignancy within the past 5 years; 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.