Children's Hospital of Fudan University — Biomedical Watch V2

Traitements2programmes

Essais1liés

Publications1liées

SourceDBlocale

Traitements

2

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
YTS109 cellThis exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed/refractory autoimmune diseases, including systemic lupus erythematosus, diffuse systemic sclerosis, idiopathic inflammatory myopathies, and Sjögren's syndrome, as well as other eligible autoimmune diseases defined by the protocol eligibility criteria. Approximately 12 patients aged 5 to \<18 years will be enrolled at Children's Hospital of Fudan University and will receive a single intravenous infusion of YTS109 cells. Dose escalation will follow a standard 3+3 design starting at 1.5 × 10\^6 cells/kg. The primary objective is to assess the safety and preliminary efficacy of YTS109 cell therapy in this population. Secondary objectives include characterizing the pharmacokinetic and pharmacodynamic profiles of YTS109 cells. Primary endpoints include the type, severity, and frequency of adverse events, along with efficacy assessments.	Lupus	Phase 1	Immunomodulation + Thérapie cellulaire	China	À vérifier
YTS109 cellThis exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed/refractory autoimmune diseases, including systemic lupus erythematosus, diffuse systemic sclerosis, idiopathic inflammatory myopathies, and Sjögren's syndrome, as well as other eligible autoimmune diseases defined by the protocol eligibility criteria. Approximately 12 patients aged 5 to \<18 years will be enrolled at Children's Hospital of Fudan University and will receive a single intravenous infusion of YTS109 cells. Dose escalation will follow a standard 3+3 design starting at 1.5 × 10\^6 cells/kg. The primary objective is to assess the safety and preliminary efficacy of YTS109 cell therapy in this population. Secondary objectives include characterizing the pharmacokinetic and pharmacodynamic profiles of YTS109 cells. Primary endpoints include the type, severity, and frequency of adverse events, along with efficacy assessments.	Lupus	Phase 1	Immunomodulation + Thérapie cellulaire	China	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
YTS109 cell	Lupus	Phase 1	NCT07439029	YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases	NOT_YET_RECRUITING

Publications

1

Molécule	Indication / population	Titre	Journal	Date
YTS109 cell		Allogeneic CD19-targeting T cells for treatment-refractory systemic lupus erythematosus: a phase 1 trial.	Nature medicine