eligibility_summary
Eligible: adults ≥18 with relapsed/refractory solid tumor lacking options, NKG2DL+ (≥10% cells), measurable disease, ECOG 0–1, normal cardiac/O2 ≥95%, adequate blood counts/chemistry, biopsyable, ≥6‑mo life expectancy, contraception/consent, agree to 15‑yr LTFU. Exclude: active HBV/HCV/HIV/HTLV/syphilis, recent anticancer therapy, prior LEU011, coumarin anticoagulants, major comorbidity, active autoimmune/infection, drug allergies, pregnancy/breastfeeding, live vaccine ≤4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: LEU011, an autologous, gene‑modified CAR T‑cell therapy (biologic). Mechanism of action: patient T cells are engineered to express a CAR that binds NKG2D ligands (NKG2DL) on target cells, engagement activates the CAR T cells to kill NKG2DL‑positive cells and release effector cytokines. Regimen: single IV infusion after lymphodepleting chemotherapy (preconditioning, agents include fludarabine/cyclophosphamide per exclusions). Trial: Phase I/IIa, open‑label, dose‑escalation to define safety/MTD in relapsed/refractory solid tumors. Targets/cells/pathways: the NKG2D–NKG2DL pathway, tumor and tumor‑associated stromal cells expressing NKG2DL (require ≥10% expression).