Recruiting Phase 2 2025-523971-46-00

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).

Phase 2 – studying effectiveness and dosage

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

Sponsor: Quell Therapeutics Limited

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Overview

Trial status: Authorised 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.

Who can participate

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 8 participants

Interventions

QEL-005

Drug

Locations 2

Germany (1)

Spain (1)

Status

Recruiting

Phase

Phase 2

Study type

INTERVENTIONAL

Sex

Male and female

Minimum age

18 Years

Healthy volunteers

Start date

21.04.2026

Registry ID

2025-523971-46-00

Source

euclinicaltrials.eu

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