Clinical trials

SCLEROCAR

Phase IIa clinical trial evaluating the safety and efficacy of T cells expressing a chimeric antigen receptor targeting CD19 (CAR T-cells) in patients with systemic sclerosis (SSc) resistant to immunosuppressive drugs

Objective: To evaluate the clinical efficacy of anti-CD19 CAR-T- cell therapy on cutaneous fibrosis as assessed by the mRSS score 6 months after administration of anti-CD19 CAR T-cells in patients with SSc resistant to immunosuppressive drugs.

Phase: Phase 1/2a multicentre, prospective, open-label trial to evaluate the safety of expanded autologous CD19 CAR-T in systemic sclerosis.

Study population: Diagnosis of systemic sclerosis according to the ACR/EULAR classification, refractory to low-dose steroids and at least two immunosuppressive treatments including DMARDs (methotrexate, azathioprine, mycophenolate mofetil) and/or rituximab or tocilizumab.

Coordinator: Christian Jorgensen

CPP favourable opinion: pending

NCT No.: pending

Coordinator
Pr Christian Jorgensen
Coordinator
EVASCLER

Safety of administration of extracellular vesicles derived from adipocyte-derived mesenchymal stem/stromal cells in systemic scleroderma

Objective: To evaluate the safety of administering extracellular vesicles derived from adipocyte-derived mesenchymal stem/stromal cells in patients with systemic scleroderma (SSc).

Phase: phase 1 clinical trial.

Coordinator: Alexandre Maria

CPP favourable opinion: pending

NCT No.: pending

Coordinator
Dr Alexandre Maria
Coordinator
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