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).

Diffuse cutaneous systemic sclerosis (dcSSc) Difficult to treat rheumatoid arthritis (D2TRA)

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., 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.

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