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TARA-002 · STARBORN-1

Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age

Ensayo de Protara Therapeutics, Inc. en Lymphatic Malformation (del registro, en inglés).

Fase

Fase 2

Estado

Reclutando pacientes

Participantes

38

previstos

Centros

11

Fin del objetivo primario

dic 2026

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2023.

Qué mide

Proportion of participants with clinical success after one treatment cycle of TARA-002 (8 weeks after the last injection) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart.

Más ensayos de TARA

Todos los de TARA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05871970), actualizada en ago 2026.