In short
QEL-005 is an investigational cell therapy being studied for the first time in people with diffuse cutaneous systemic sclerosis (dcSSc) and difficult to treat rheumatoid arthritis (D2TRA). It has no marketing authorisation and is given as a single intravenous infusion. One Phase 1/2 trial, authorised in the EU, is testing its safety and tolerability in 16 participants.
Key points
- QEL-005 is an investigational cell therapy with no marketing authorisation.
- It is being studied in diffuse cutaneous systemic sclerosis (dcSSc) and difficult to treat rheumatoid arthritis (D2TRA).
- The single trial is in Phase 1/2 and is currently authorised.
- The trial plans to enrol 16 participants.
- QEL-005 is given as a single intravenous infusion.
- The main goal is to assess safety and tolerability, including dose-limiting toxicities and adverse events.
What is QEL-005?
QEL-005 is an investigational cell therapy developed by Quell Therapeutics Limited. It is classified as a structurally diverse substance of cell therapy origin in the EU Clinical Trials Information System (CTIS) product records, meaning it is derived from living cells rather than being a conventional chemical medicine. QEL-005 has no marketing authorisation, which means it is not yet approved as a medicine and can only be given to people taking part in clinical trials.
How does QEL-005 work?
The trial records do not describe the mechanism of action of QEL-005 in detail. As a cell therapy, it is designed to act on the immune system, but the exact way it works has not been stated in the available registry data.
Which conditions is it used or studied for?
QEL-005 is being studied in two autoimmune conditions:
- Diffuse cutaneous systemic sclerosis (dcSSc) — a rare autoimmune disease in which the skin and sometimes internal organs become thickened and hardened due to excess collagen.
- Difficult to treat rheumatoid arthritis (D2TRA) — a form of rheumatoid arthritis that has not responded adequately to multiple standard treatments.
How is QEL-005 given?
QEL-005 is given as a single intravenous infusion, meaning it is delivered directly into a vein. The pharmaceutical form recorded in the product records is an infusion.
What do the clinical trials show?
There is one clinical trial of QEL-005, identified as study QEL-005-CLN-01. It is a Phase 1/2 interventional study that is currently authorised in the EU. The trial plans to enrol 16 participants across the two conditions.
The study is divided into two parts. The dose escalation part will look at the incidence of protocol-defined dose-limiting toxicities (DLTs) within 14 days after the infusion, as well as treatment-emergent serious adverse events (SAEs), adverse events (AEs), and adverse events of special interest (AESIs). The expansion part will continue to monitor treatment-emergent SAEs, AEs and AESIs, along with clinically significant changes in safety laboratory assessments, electrocardiogram (ECG) and vital signs. The stated purpose of the trial is to determine the safety and tolerability of a single dose of QEL-005.
What side effects are known?
No side effect data for QEL-005 are available in the registry records. Because this is a first-in-human study, the trial itself is designed to detect and record adverse events, including serious adverse events and adverse events of special interest.