eligibility_summary
Adults (>=18) with relapsed/refractory B-ALL or high-risk newly diagnosed B-ALL (KMT2A-rearranged, complex cytogenetics per NCCN 2022, low-hypodiploidy/tetraploidy, or Ph-like via CRLF2 overexpression/recurrent fusions). ECOG 0-2, adequate organs (Cr <=1.6, bili <=3.5, ALT/AST <=5x ULN), CD19 >=50%. Controlled HBV/HCV/HIV allowed. Exclude Ph+ B-ALL, pregnancy/lactation (WOCBP neg test), prior anti-CD19 CAR T/brexu-cel, uncontrolled disease/infection, no consent, investigational therapy <14 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib/II single-arm trial in relapsed/refractory or high-risk newly diagnosed B-ALL testing brexucabtagene autoleucel (brexu-cel), an autologous anti-CD19 CAR T-cell therapy, as consolidation after cytoreduction with inotuzumab ozogamicin + blinatumomab + Hyper-CVAD/mini-hyper-CVD. Mechanisms: brexu-cel redirects patient T cells to CD19+ B-lymphoblasts via CAR signaling to induce cytotoxicity and B-cell aplasia, blinatumomab is a bispecific T-cell engager (BiTE) that links CD3 on T cells to CD19 on B cells, activating T-cell killing, inotuzumab ozogamicin is an anti-CD22 antibody-drug conjugate delivering calicheamicin to CD22+ blasts, causing DNA double-strand breaks, Hyper-CVAD/mini-hyper-CVD are multi-agent cytotoxic chemotherapies (alkylation, microtubule inhibition, topoisomerase II inhibition, antimetabolites, glucocorticoid-induced apoptosis). Targets: CD19, CD22, CD3/T-cell activation, DNA damage pathways.