eligibility_summary
Adults ≥18 with LGR5+ metastatic colorectal cancer, ECOG 0–1, measurable/evaluable disease, life expectancy >12 weeks, adequate organ/marrow, ≤2 prior 5-FU/oxaliplatin/irinotecan regimens, ≥4-week washout, contraception and negative pregnancy test. Exclude: BRAF-mut, prior TAS-102 or regorafenib, CNS disease, significant GI disease/diarrhea, serious infection/autoimmune/IBD, cardiac/QTc issues, lung disease, ascites/peritoneal/liver/biliary risks, recent surgery, other trials/biologics.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/Intervention: CNA3103, an autologous chimeric antigen receptor T-cell (CAR-T) therapy, delivered as a single IV infusion after lymphodepleting chemotherapy (dose escalation 2.5×10^7–1.5×10^9 cells). Mechanism of action: patient T cells are engineered to express a CAR that binds LGR5 (leucine-rich repeat-containing GPCR5), triggering antigen-dependent T-cell activation and cytotoxic killing of LGR5+ tumor cells. Targets: LGR5-expressing metastatic colorectal cancer cells, including putative cancer stem cells, LGR5 is linked to R-spondin/Wnt–beta-catenin signaling. Study goal: determine safety, RP2D, PK/PD, and antitumor activity.