eligibility_summary
Eligibility: MCL - cyclin D1+ or t(11,14), ≤5 prior lines incl anthracycline/bendamustine/HiDAC, anti-CD20, and BTKi, relapsed/refractory, ≥1 measurable lesion (LN ≥2 cm if nodal only). Exclude: autoSCT <6 wk, prior alloSCT unless no donor cells >100 d, prior CD19/CAR-T, other malignancy <3 y, hypersensitivity. ALL - R/R B-ALL with >5% marrow blasts, post-alloSCT allowed (>100 d, off IS ≥4 wk), Ph+ if TKI-intolerant or failed ≥2 TKIs. Exclude: Burkitts/CML LBC, other malignancy <3 y, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 study in Japan testing KTE‑X19 (brexucabtagene autoleucel, Tecartus), an autologous anti‑CD19 chimeric antigen receptor (CAR) T‑cell therapy. Mechanism: patient T cells are engineered to express a CAR that recognizes CD19 on B cells, activating T‑cell cytotoxicity to eliminate CD19+ malignant and normal B cells (often causing B‑cell aplasia). Preconditioning uses cyclophosphamide (alkylating DNA crosslinker) and fludarabine (purine analog inhibiting DNA synthesis) to lymphodeplete and enhance CAR‑T expansion. Targets: CD19 on B‑cell lineage in r/r MCL and B‑precursor ALL, broad host lymphocytes via lymphodepletion.