eligibility_summary
Adults 18–75 with refractory/metastatic solid tumors, ≥1 measurable lesion, ECOG 0–1, life expectancy >6 mo, consent and a resectable tumor‑associated LN for T‑cell isolation, use contraception and attend visits. Exclude active infection, autoimmune disease, uncontrolled heart/lung disease, recent major CV events, severe allergy, pregnant/lactating, uncontrolled CNS mets, prior allogeneic transplant, ILD, HIV/HBV/HCV, uncontrolled effusions, second primary tumor, concurrent study.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT06302062 tests tumor-associated lymph node T cells (TAL-T, autologous adoptive cell therapy) alone or combined with serplulimab (anti–PD-1 mAb, immune checkpoint inhibitor) in refractory advanced solid tumors. Supportive agents: cyclophosphamide (alkylating chemo used for lymphodepleting conditioning to reduce Tregs/competition and boost homeostatic cytokines) and IL-2 (recombinant cytokine to expand/sustain infused T cells). Mechanisms: TAL-T are tumor-draining lymph node–primed, tumor-reactive T cells that recognize tumor antigens via TCRs and mediate cytotoxicity, serplulimab blocks PD‑1/PD‑L1 inhibitory signaling to reverse T-cell exhaustion, IL‑2 activates IL‑2R–JAK/STAT and PI3K/AKT to promote T-cell proliferation, cyclophosphamide targets suppressive lymphocytes (e.g., Tregs) and creates marrow “space.” Targets/pathways: tumor-reactive CD8+/CD4+ T cells, PD‑1/PD‑L1 axis, TCR signaling, IL‑2R signaling, TME immunosuppression.