Purpose of this Study
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.
Who Can Participate?
Eligibility
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.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
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
Principal Investigator
Ankoor
Shah
Protocol Number
PRO00119785
NCT ID
NCT07115745
Phase
I
Enrollment Status
Pending Open to Enrollment