eligibility_summary
Inclusion: Untreated MCL (cyclin D1+ or t(11,14)) with high-risk (MIPI-c HI/H or int+Ki-67≥30% and/or TP53), stage II–IV, age 18–75, measurable disease, ECOG≤2, adequate labs/organ function, no CNS disease, contraception/negative pregnancy test, no driving 8 wks post CAR-T. Exclusion: Inability to consent, hypersensitivity, recent trial, psych/substance abuse, major comorbidity (cardiac, O2≤92%, severe DM), pregnancy/active cancer, uncontrolled infection or HBV/HCV/HIV, CNS disorder/autoimmune, recent VTE, immunodeficiency, live vaccine ≤6 wks, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II trial in untreated high‑risk mantle cell lymphoma compares early CAR‑T consolidation vs standard care. Interventions/mechanisms: KTE‑X19 (brexucabtagene autoleucel)—autologous anti‑CD19 CAR‑T cells (cell therapy) that recognize CD19 and kill malignant B cells via T‑cell cytotoxicity. Ibrutinib—oral covalent BTK inhibitor (small molecule) blocking B‑cell receptor (BCR) signaling to reduce proliferation/survival/trafficking. Rituximab—anti‑CD20 monoclonal antibody (mAb) mediating ADCC/CDC/apoptosis of B cells. Lymphodepletion with fludarabine (purine analog) and cyclophosphamide (alkylator) to enhance CAR‑T expansion. Comparator chemoimmunotherapy: R‑CHOP (cyclophosphamide—alkylator, doxorubicin—topo II inhibitor, vincristine—microtubule inhibitor, prednisone—glucocorticoid), R‑DHAP, bendamustine (alkylator), ± ASCT. Targets/pathways: CD19 and CD20 on malignant B cells, BTK/BCR pathway, DNA synthesis/repair and microtubules (cytotoxics).