Phase 12 Study of QEL-005 Cell Therapy for Adults with Diffuse Cutaneous Systemic Sclerosis and Difficult-to-Treat Rheumatoid Arthritis

What this Trial Is About

Researchers are evaluating an experimental treatment called QEL-005 in adults with two autoimmune conditions diffuse cutaneous systemic sclerosis dcSSc and difficult-to-treat rheumatoid arthritis D2TRA. This Phase 12, open-label clinical trial aims to assess the safety, tolerability, and potential effects of QEL-005 on disease activity and symptoms in these participants. QEL-005 is a new type of therapy made from each participants own white blood cells, which are genetically modified to target a specific protein on B cells. Participants will first undergo leukapheresis to collect white blood cells, which are then modified in the lab to create CAR-T regulatory cells targeting CD19. These modified cells are infused back into the participant through an intravenous IV infusion. The study includes a dose escalation phase with increasing doses to find a safe and tolerable level, followed by a dose expansion phase using the selected dose. Participants will stay overnight in hospital for monitoring after infusion. During the trial, participants will attend scheduled visits for safety checks including blood tests, imaging scans, questionnaires, and tissue biopsies to understand how QEL-005 works in the body. Detailed follow-up continues for one year after infusion, with additional long-term monitoring planned for up to 15 years. Researchers will measure adverse events, disease activity scores, skin and lung assessments, and immune system changes to evaluate safety and biological effects of the treatment.

Controlling Hyperactive Immunity With Long-lived Lymphocytes