eligibility_summary
Eligible: BCG‑exposed high‑grade NMIBC (Ta/T1/Tis, >50% urothelial, restaging TURBT shows no T2), visible cystoscopic disease, tissue for TIL, ECOG 0–1, adequate organ/marrow, consent. Exclude: intravesical chemo <6 mo, recent immunosuppression/lymphocyte‑affecting therapy, serious cardiac/illness, HIV/HBV/HCV/syphilis, TB, live vaccine <30 d, transplant/immunodef, active infection, >G2 toxicity, pneumonitis, active autoimmune, other cancer <2 y, pregnancy/no contraception, penicillin allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Autologous adoptive cell therapy using tumor-infiltrating lymphocytes (TIL) harvested from bladder tumors, expanded ex vivo with interleukin‑2 (IL‑2) and anti‑CD3 mAb (rapid expansion), then administered intravesically four times (up to 3.2×10^8 cells). Type: Cellular immunotherapy/biologic. Mechanism of action: Ex vivo activation and massive expansion of patient’s tumor‑reactive T cells, IL‑2 drives IL‑2R/JAK‑STAT5 signaling for proliferation/survival, anti‑CD3 provides TCR/CD3 stimulation for clonal expansion. Targets: High‑grade non‑muscle‑invasive urothelial carcinoma cells in the bladder, adaptive T‑cell pathways (CD8+/CD4+ TIL recognizing tumor antigens via TCR), with effector cytotoxic mechanisms (perforin/granzyme, IFN‑γ). Intravesical delivery focuses activity within the bladder and limits systemic exposure.