Purpose of this Study
In this study, people may be placed into one of two groups when they join. One group will receive chemotherapy that lowers the immune system before getting the study treatment, and the other group will not. Everyone in the study will receive special CAR T cells that are made to fight disease. After receiving the cells, participants will stay in the hospital for several days so doctors can watch their health closely. They must also stay near the study center for about 45 days and will have regular doctor visits during that time.
Who Can Participate?
Eligibility
People can join this study if they have an autoimmune disease such as lupus, inflammatory muscle disease, or systemic sclerosis. These diseases happen when the immune system attacks the body by mistake. Participants must have active disease but also be healthy enough for their organs to work well so they can safely take part in the study procedures.
Age Range
18-70
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 cells to see if it is safe for people with autoimmune diseases. In autoimmune diseases, the body attacks itself by mistake. The CAR T cells used in this study come from a donor and are changed in a lab to help remove or reduce harmful immune cells. Researchers want to learn if this treatment can safely help control these diseases.
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DRA02 - A PHASE 1 STUDY EVALUATING THE SAFETY AND PRELIMINARY EFFICACY OF ALLO-329, A DUAL ANTI-CD19 / ANTI-CD70 ALLOGENEIC CAR T CELL PRODUCT IN AUTOIMMUNE DISEASE (RESOLUTION)
Principal Investigator
Lisa
Criscione-Schreiber
Protocol Number
PRO00118071
NCT ID
NCT07085104
Phase
I
Enrollment Status
Open to Enrollment