eligibility_summary
Adults >=18 with R/R AML lacking standard options (failure/relapse/MRD+, incl post-allo SCT/DLI), HLA-A02:01+, NPM1-mut qPCR-monitorable, WBC >1e9/L, <20% blasts, >=0.3e9 T and >=0.03e9 CD8+ cells/L, ECOG 0-3, life >=3 mo, neg pregnancy test/contraception. Exclude: pregnancy/lactation, HIV/HBV/HCV/HTLV/SARS-CoV-2/syphilis, unstable disease/organ failure, high-dose immunosuppression, uncontrolled CNS disease or severe infection/DIC, other IMP, hypersensitivity, creatinine >=2x ULN or eGFR <30, BMI >=40, live vaccine <6 wk, surgery <30 d, institutionalized.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: MB-dNPM1-TCR.1, an autologous T-cell receptor (TCR)–engineered T-cell therapy (gene-modified cellular immunotherapy). Patient T cells are collected, lentivirally transduced ex vivo to express a TCR that recognizes mutant NPM1 (dNPM1) peptides presented by HLA-A02:01, expanded, and reinfused after lymphodepleting chemotherapy. Mechanism: engineered TCR enables CD8+ T cells to bind the HLA-A02:01/dNPM1 peptide complex on leukemic myeloid cells, driving antigen-specific cytotoxic killing and clearance of NPM1-mutant AML. Targets: NPM1 mutation–derived neoantigen peptides, HLA class I antigen presentation pathway (HLA-A02:01), leukemic blasts/myeloid cells expressing dNPM1. Trial: Phase I/II, single-arm dose escalation (BOIN) to MTD/RP2D, then Simon two-stage expansion for efficacy.