eligibility_summary
Adults ≥18 with CD19+ NHL, R/R or HSCT‑ineligible, ECOG ≤2, measurable, FDG‑avid disease (Phase Ib: nodal ≥1.5 cm or non‑nodal ≥1.0 cm, LBCL preferred). Labs: bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, CrCl ≥30, EF ≥45%, SaO2 ≥92%. ≥2 wks since prior therapy (≥28 days for investigational). Exclude: auto‑HCT <6 wks, prior allo‑HCT, active CNS, other active malignancy, major CV disease, HIV/hep B/C PCR+, pregnancy/breastfeeding, MDS, CNS disorders, uncontrolled illness, active autoimmune on immunosuppression, circulating malignant B cells.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05400109 tests UF-KURE19, an autologous, gene-modified cellular immunotherapy (CD19-directed CAR-T). Patient T cells are lentivirally transduced (3rd‑generation vector, FMC63 scFv) and rapidly manufactured (~17–20 h culture) then infused. Mechanism: CAR engagement of CD19 activates T cells to proliferate and kill CD19+ B cells, depleting malignant (and normal) B cells. Lymphodepletion uses fludarabine (antimetabolite purine analog, active 2‑F‑ara‑ATP inhibits DNA polymerase α, ribonucleotide reductase, DNA primase—blocking DNA synthesis) and cyclophosphamide (alkylating agent causing DNA cross‑links) to enhance CAR‑T expansion. Targets: CD19 on B‑cell NHL, B‑cell receptor/CD19 signaling axis, host lymphocyte DNA synthesis pathways (conditioning).