Calendario›COGT›Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product

Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product

Ensayo de Cogent Biosciences, Inc. en B Cell Lymphomas · Multiple Myeloma · Solid Tumor · HER-2 Protein Overexpression (del registro, en inglés).

Más ensayos de: Mieloma múltiple · Tumor sólido.

Fase

no aplica

Estado

Interrumpido

Participantes

22

previstos

Centros

16

Fin del objetivo primario

oct 2020

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en oct 2016.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Business Decision».

Qué mide

Long-term safety of ACTR T cell product as assessed by overall survival (Total of 15 years after first receiving an ACTR T cell product) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroSubjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.

Más ensayos de COGT

Todos los de COGT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02840110), actualizada en oct 2021.