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DRA04: BMS CAR-T - Clinical Trial

¿Cuál es el Propósito de este estudio?

In this study, participants will first receive chemotherapy for one to three days to lower their immune system. After that, they will receive special CAR T cells in the hospital and stay there so doctors can watch them closely. For the first month after receiving the cells, participants will be monitored very carefully and must stay near the study center for about 30 days. After that, they will return to the clinic once a month for at least two years so doctors can continue to check their health.

¿Cuál es la Condición que se está estudiando?

This study is for people who have autoimmune diseases that affect the immune system. In these diseases, the body attacks itself by mistake. The study includes conditions such as lupus, inflammatory muscle disease, systemic sclerosis, and rheumatoid arthritis. These conditions can cause pain, swelling, and problems in different parts of the body.

¿Quién puede participar en el Estudio?

People can join this study if they are adults who have autoimmune diseases such as lupus, inflammatory muscle disease, systemic sclerosis, or rheumatoid arthritis. These diseases are active, which means they are currently causing symptoms. Participants must also be healthy enough overall to safely take part in the study.

Grupo etario
Adultos

¿Qué Implica?

This study is testing a special treatment called CAR T cell therapy for people with autoimmune diseases. In these diseases, the immune system attacks the body by mistake. The treatment uses cells from a donor that are changed in a lab so they can find and remove certain harmful immune cells called B cells. Researchers want to learn if this treatment is safe and find the right dose to use.

Detalles del Estudio

Título Completo
DRA04: A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Autoimmune Diseases
Investigador Principal
Ankoor Shah, MD
Especialista en reumatología
Número de Protocolo
IRB: PRO00119785
NCT: NCT07115745
Fase
Fase I
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción
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Contribuya a Duke Health