eligibility_summary
Eligibility: AML patients >6 months with CLL-1/CD123/CD38/CD33+ blasts, KPS>80, life expectancy >3 mo, adequate organs (EF>=50%, O2>=90%, Cr<=2.5xULN, AST/ALT<=3xULN, bili<=2.0 mg/dL), Hgb>=80 g/L, no cell-separation contraindications, consented. Exclude: severe/uncontrolled infection, HIV or active HCV, pregnant/nursing, systemic steroids <1 wk, prior gene therapy, MRD>50%, likely noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Off-the-shelf “universal” CAR T-cell therapy (biological, adoptive cellular immunotherapy) targeting CLL-1, CD33, CD38, and/or CD123. Mechanism of action: Patient-independent T cells are engineered to express chimeric antigen receptors that bind these AML antigens, activating T-cell cytotoxicity to kill malignant cells, trial also assesses CAR-T persistence and function. Cells/pathways targeted: AML blasts and leukemic stem cells expressing CLL-1 (CLEC12A, enriched on LSCs, minimal on normal HSCs), CD33 (myeloid lineage antigen), CD38 (surface ectoenzyme/receptor), and CD123 (IL-3Rα). Primary biological pathway: antigen-specific CAR signaling leading to T-cell activation and direct lysis of AML cells in bone marrow. Phase: Early-phase/Phase 1, single-arm, in relapsed/refractory AML.