eligibility_summary
Include: 18–72, ECOG 0–1, metastatic solid tumor with KRAS G12V/G12D and HLA match for KRAS TCR, refractory (CRC: oxaliplatin/irinotecan, breast/ovarian: ≥2 lines, NSCLC: platinum + targeted, others: ≥1 line/declined), ≤3 asymptomatic brain mets <1 cm, contraception, HIV/HBV/HCV‑neg, adequate labs. Exclude: pregnancy/nursing, immune deficiency/suppression, active infection/major illness, unpalliable bronchial bleed/occlusion, major cardiac/pulmonary disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06253520 tests: 1) KRAS TCR‑transduced peripheral blood lymphocytes (biologic, autologous gene‑modified T‑cell therapy) engineered to express T‑cell receptors specific for KRAS G12D or G12V neoantigens (HLA class I or II restricted) to recognize HLA‑presented mutant KRAS peptides and kill tumor cells, 2) GRT‑C903 (adenoviral vector prime) + GRT‑R904 (mRNA boost) vaccine (biologic) to induce/expand KRAS‑mutant–specific T cells and support infused cells, 3) Cyclophosphamide (alkylating agent) + fludarabine (purine analog) for lymphodepletion, 4) High‑dose aldesleukin/IL‑2 (cytokine) to promote T‑cell expansion. Targets: tumor cells harboring KRAS G12D/G12V, HLA class I/II antigen presentation, CD8+ and CD4+ T‑cell responses, TCR signaling and cytotoxic pathways (perforin/granzyme).