Clinical trials

A Phase 2a 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

Condition studied : Systemic sclerosis
Treatment : Anti-CD19 CAR-T cells
Sponsor : Montpellier University Hospital
Principal Investigator : Pr. Christian Jorgensen
: CTIS 2024-519511-33-00
Investigator
Pr. Christian Jorgensen
Director

Safety of the administration of extracellular vesicles derived from adipose-derived mesenchymal stem cells in systemic sclerosis. A phase I study

Condition studied : Systemic sclerosis
Treatment : Extracellular vesicles derived from adipose-derived mesenchymal stem cells
Sponsor : Montpellier University Hospital
Principal Investigator : Dr. Alexandre Maria
: ongoing
Investigator
Dr. Alexandre Maria
Internal medicine specialist

Open-label trial with a long-term extension of RAY121 for the inhibition of the classical complement pathway in immunological diseases. Phase 1b

Condition studied : Bullous pemphigoid, Antiphospholipid syndrome, Autoimmune necrotising myopathy, Behçet’s disease, Dermatomyositis, Immune thrombocytopenic purpura
Treatment : Repeated subcutaneous administration of RAY121
Sponsor : CHUGAI
Principal Investigator : Pr. Christian Jorgensen
: NCT 06371417, EU CT 2023-507692-21-00
Investigator
Pr. Christian Jorgensen
Director

A trial evaluating the safety and pharmacokinetics/pharmacodynamics of a bispecific antibody (CD19/CD3) in systemic lupus erythematosus. A multicentre phase 1 trial

Condition studied : Systemic lupus erythematosus
Treatment : Administration of a bispecific CD19/CD3 antibody
Sponsor : Roche
Principal Investigator : Dr. Alexandre Maria
: NCT 05835986, EU Trial 2022-502632-39-00
Investigator
Dr. Alexandre Maria
Internal medicine specialist

Efgartigimod PH20 SC in adult participants with systemic sclerosis. A phase 2, randomised, double-blind, placebo-controlled trial

Condition studied : Systemic sclerosis
Treatment : Injection of Efgartigimod or placebo
Sponsor : ARGX
Principal Investigator : Pr. Christian Jorgensen
: EU CT 2024-514539-67
Investigator
Pr. Christian Jorgensen
Director

A Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5492 following administration of a single ascending dose and dose-escalation in adult participants

Condition studied : Systemic lupus erythematosus, Idiopathic inflammatory myopathies
Treatment : Repeated injections of AZD5492
Sponsor : Astrazeneca
Principal Investigator : Pr. Christian Jorgensen
: EU CT 2024-511346-39-00
Investigator
Pr. Christian Jorgensen
Director

A Phase 2a, open-label study to evaluate the safety and efficacy of AlloNK® (allogeneic NK-cell therapy derived from umbilical cord blood) in combination with rituximab in relapses of B-cell-dependent rheumatic diseases

Condition studied : Systemic sclerosis, Rheumatoid arthritis, Idiopathic inflammatory myopathies
Treatment : Combined administration of AlloNK® and Rituximab
Sponsor : Artiva
Principal Investigator : Pr. Christian Jorgensen
: NCT 06991114, EU CT 2025-520461-41-00
Investigator
Pr. Christian Jorgensen
Director

Injection of adipose-derived mesenchymal stem cells for the management of digital ulcers in systemic sclerosis. A phase 2, multicentre, randomised, placebo-controlled trial

Condition studied : Systemic sclerosis
Treatment : Injection of mesenchymal stem cells or a placebo
Sponsor : Toulouse University Hospital
Principal Investigator : Dr. Alexandre Maria
: Eudra CT 2019-003906-28, EU CT 2023-508432-53-00
Investigator
Dr. Alexandre Maria
Internal medicine specialist
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