86
Participants
Start Date
October 28, 2025
Primary Completion Date
April 30, 2029
Study Completion Date
April 30, 2029
aldesleukin
Aldesleukin 600,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses).
cyclophosphamide
300 mg/m\^2 IV infusion over 30 minutes. Daily x 3 doses on days -5, -4, -3.
fludarabine phosphate
30 mg/m\^2 IV infusion over 30 minutes administered immediately following cyclophosphamide on day -5, -4, -3. Participants with renal dysfunction receive a lower dose of fludarabine.
Individual Patient TCR-Transduced PBL
Up to 1.5x10\^11 total cells for non-transplant subjects. 1x10\^10 total cells for post-alloHSCT subjects.
TruSight Oncology (TSO) 500
TSO500 sequencing panel performed in the NCI Laboratory of Pathology to detect TP53 or RAS mutations
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH