eligibility_summary
Eligible: age 1–70 with grade II–IV steroid-refractory/resistant or -dependent GVHD after allo-HSCT, failed ruxolitinib/≥1 second-line or intolerant, ECOG 0–3, life expectancy >12 wks, contraception and consent required. Exclude: recent malignancy (some in situ/skin allowed), prior organ transplant, >1 allo-HSCT, major cardiac/QTc>500, unstable systemic disease, active TB/HIV/syphilis or severe infection, recent trial, prior gene therapy, allergy, psych/substance issues, pregnancy/breastfeeding or planned birth, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CNK-UT cells—biological, engineered “universal” T‑cell therapy expressing a chimeric natural killer (NK) receptor. Mechanism: the chimeric NK receptor endows T cells with NK-like recognition of stress‑induced NK‑ligands on dysregulated/activated immune cells, engagement triggers T-cell activation and cytotoxicity (perforin/granzyme) and immunomodulation, aiming to eliminate the pathogenic immune cells driving steroid‑refractory/resistant or steroid‑dependent GVHD. Targets: alloreactive/activated donor T cells, antigen‑presenting cells, and other immune cells expressing NK‑receptor ligands in GVHD lesions, key pathways include NK receptor–ligand recognition, T‑cell effector cytotoxic pathways, and downstream inflammatory cytokine cascades. Phase 1 SAD/MAD IV dosing.