Vanderbilt-Ingram was among the first in the nation to establish outpatient protocols for another personalized immunotherapy, CAR-T.
Researchers recommended long-term follow-up for patients by dermatologists familiar with cirAEs and consideration of corticosteroid-sparing treatment options.
The panel determined that allowing the wider indication would put patients at risk for adverse reactions from the two immunotherapies but without the added benefit in survival.
The therapy, P-BCMA-ALL01, demonstrated a 91% overall response rate for the 23 patients participating in the phase 1 trial.
The study seeks to understand the mechanisms of colorectal cancer and builds on recent Vanderbilt research.
The findings were so promising that the clinical trial is being redesigned to investigate whether radiation treatment can also be avoided.