eligibility_summary
Eligibility: Adults 18–75 with GCC‑positive solid tumors that failed/are intolerant to standard therapy or relapsed, ≥1 measurable lesion (RECIST 1.1), ECOG 0–2, adequate organ function, LVEF>50%, no bleeding disorders, life expectancy ≥12 wks, consent. Exclude: pregnancy, recent trials, serious CV/CNS disease, prior immune‑cell/GCC therapy, uncontrolled infection, HBV/HCV/HIV/syphilis, active autoimmunity, recent surgery, recent DVT/PE, immunosuppressants, drug allergies, substance abuse/unstable psych.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05875402 tests XKDCT080, a chimeric antigen receptor T-cell (CAR-T) therapy targeting guanylyl cyclase C (GCC). Type: cellular gene therapy/adoptive T‑cell immunotherapy. Mechanism: patient T cells are engineered to express a CAR that binds GCC on tumor cells, triggering T‑cell activation, cytotoxic killing (perforin/granzyme), and cytokine release after intravenous infusion. Design: single‑center, single‑arm, 3+3 dose escalation in 9–18 patients with GCC‑positive, recurrent/refractory solid tumors (notably colorectal). Targets and pathways: GCC on tumor cells, activation of CAR‑mediated T‑cell effector pathways, study correlates cytokine dynamics with efficacy and characterizes CAR‑T pharmacokinetics/persistence. Primary aim: safety/tolerability, secondary: PK, preliminary efficacy, cytokine–response relationships.