eligibility_summary
Include: high-risk or t-MDS, or R/R AML, ALC ≥200/µL or NK ≥25/µL, blasts ≤20,000 (hydroxyurea allowed), KPS ≥70, adequate organs, SpO2 ≥95%, contraception/consent, dose-finding: within 60 min of site. Exclude: pregnancy/nursing, HSCT candidate/recent post-HSCT relapse, biphenotypic leukemia or APL, therapy <14 d or unresolved AEs, active infection/new infiltrates, HIV, active/positive HBV/HCV, CNS disease, steroids >10 mg/immunosuppression, QTc >480/long QT, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 dose-escalation trial of GTB-3650, an engineered trispecific biologic immunotherapy (TriKE: anti-CD16/IL-15/anti-CD33) for high-risk MDS and relapsed/refractory AML. Mechanism: bridges NK cells to tumor by binding CD16 (FcγRIIIa) on NK cells to trigger cytotoxicity, targets CD33 on leukemic cells and myeloid-derived suppressor cells (MDSCs) for directed killing, and incorporates an IL-15 moiety to expand and sustain NK cells. Targets and pathways: NK cells via CD16 engagement and IL-15–JAK/STAT signaling, CD33+ myeloid blasts, CD33+ MDSCs to alleviate tumor-induced immunosuppression. Administered as single-agent continuous infusions in 28-day cycles.