Peripheral blood cellular profile at pre-lymphodepletion is associated with CD19-targeted CAR-T cell-associated neurotoxicity.
Serena De Matteis, Michele Dicataldo, Beatrice Casadei...
https://pubmed.ncbi.nlm.nih.gov/36726971Actively Recruiting
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-27
150
Participants Needed
1
Research Sites
254 weeks
Total Duration
Researchers are studying a new type of cancer treatment called CAR-T immunotherapy, which uses specially modified T cells to target and destroy cancer cells. This therapy is for patients with certain blood cancers that have not responded to other treatments, including forms of lymphoma, leukemia, and multiple myeloma. CAR-T therapy gives patients reprogrammed immune cells that can better recognize and attack cancer, overcoming some limitations of the body's natural immune responses. The study focuses on analyzing blood samples from patients undergoing CAR-T therapy at multiple time points before and after treatment, up to one year later. Researchers will examine epigenetic changes, microRNA levels, and different immune cell populations to understand how these factors relate to patient outcomes. The study will include about 35 patients per year over five years and will use samples collected during routine clinical care. Participants will provide peripheral blood samples at various stages, including before apheresis, on treatment day, and multiple days post-infusion. The research aims to link biological markers with clinical results to better understand and manage complications like inflammatory responses and neurological effects. This may help improve how CAR-T therapy is personalized and its safety monitored in patients with advanced blood cancers.
CONDITIONS
Tissue Study in Patients Undergoing CAR-T Cell Therapy (CAR_21_01)
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Total: 1 location
1
IRCC, University Hospital of Bologna
Bologna, Italy, Italy, 40138
Actively Recruiting
F
Franscesca Bonifazi, MD
E
Enrica Tomassini, DM
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Serena De Matteis, Michele Dicataldo, Beatrice Casadei...
https://pubmed.ncbi.nlm.nih.gov/36726971