eligibility_summary
Key eligibility: adults 18–75, ECOG 0–1, >3‑mo survival, advanced recurrent/metastatic solid tumor post ≥2 lines, CD70+ by IHC, measurable disease, adequate marrow/renal/hepatic/coagulation, negative pregnancy test and contraception, consent. Exclude: recent cell therapy, high‑bleed esophageal CA, recent other cancers, CNS disease, recent systemic anti‑cancer Tx, HBV/HIV/HCV, active infection, cardiac/respiratory issues, effusions, autoimmune disease, steroids, pregnant/lactating, other unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, single-arm trial of CGC729, a CD70-targeted CAR-NKT cell therapy, in adults with CD70-positive advanced solid tumors. Intervention: leukapheresis-derived CAR-NKT cells infused after lymphodepleting chemotherapy with cyclophosphamide (alkylating agent) and fludarabine (purine analog). Doses: 5.0×10^6 or 1.5×10^7 CAR-NKT cells/m2. Mechanisms: CAR-engineered natural killer T cells recognize CD70 on tumor cells and kill them via CAR signaling–driven cytotoxicity and cytokine release, largely MHC-independent, with potential remodeling of the tumor microenvironment. Cyclophosphamide and fludarabine deplete endogenous lymphocytes (including regulatory/suppressive cells) to enhance CAR cell engraftment and expansion. Targets: CD70/TNFSF7 antigen (the CD27 ligand) on tumor cells, effector pathway is CAR activation in NKT cells.