eligibility_summary
Inclusion: 14–70, grade II–IV steroid‑refractory/resistant/dependent aGVHD after allo‑HSCT, ECOG 0–3, expectancy >12 wks, pregnancy test/contraception, consent. Exclusion: recent malignancy (in‑situ/skin exceptions), prior organ transplant or >1 allo‑HSCT, uncontrolled CV/organ/metabolic disease, active infection incl. TB/HIV/syphilis, recent trial (<12 wks), gene therapy, CNK‑UT allergy, psych/substance disorders, pregnant/lactating or planning pregnancy ≤1 yr, investigator‑judged unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06750133. Intervention: Chimeric Natural Killer Receptor Universal T-cells (CNK-UT), type: allogeneic, gene‑engineered adoptive cellular therapy (biologic). Dosing: IV single dose 3×10^7 CNK+ cells/kg (dose escalation) followed by multiple doses 6–10×10^7 CNK+ cells/kg (dose expansion). Mechanism of action: patient receives “universal” T cells engineered to express chimeric NK receptors, these receptors harness NK receptor–mediated recognition and signaling on T cells to trigger cytotoxic and immunomodulatory functions, aiming to dampen the pathogenic immune response in steroid‑refractory/‑dependent acute GVHD. Cells/pathways targeted: alloreactive immune cells driving aGVHD (primarily T cells) and associated inflammatory pathways, activation occurs via NK receptor signaling pathways embedded in the engineered T cells. Phase: early phase/Phase 1, single‑arm, open‑label.