eligibility_summary
Eligibility: Age 1–70 with CD33+ AML (primary refractory/relapsed, extramedullary, MRD+ or post-allo-HSCT relapse), ECOG 0–2, life expectancy ≥60 days, consent per age, and a suitable allo-HSCT donor. Exclude: PB tumor load >30%, intracranial hypertension/lesions or impaired consciousness, heart failure/arrhythmia, severe respiratory failure, other malignancy, DIC, renal dysfunction, active infection/sepsis, uncontrolled diabetes, severe mental illness, prior solid-organ transplant, pregnancy, hepatitis B/C, HIV, syphilis, severe allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: FL-33 CD33-directed CAR T-cell therapy (genetically engineered cellular immunotherapy), given IV at two dose levels. Product sources: autologous, prior-HSCT donor-derived, or newly matched donor-derived. Mechanism of action: patient/donor T cells are modified to express a chimeric antigen receptor that binds CD33 (Siglec-3) on AML cells, triggering antigen-dependent T-cell activation via CAR intracellular signaling (CD3ζ plus co-stimulation) and HLA-independent cytotoxicity (cytolytic granule release and cytokines). Cells/pathways targeted: CD33-positive AML blasts (marrow and extramedullary) and normal CD33+ myeloid progenitors/monocytes, engagement of the CD33 surface receptor on targets and CAR signaling in T cells. Primary aim: safety and optimal biological dose.