eligibility_summary
Adults ≥18 with adequate renal/hepatic/pulm function and DLBCL (NOS, transformed FL, PMBCL, or high‑grade BCL non‑Burkitt) that is refractory/relapsed (≤12 mo after last therapy or ASCT, or after ≥2 regimens incl anthracycline+CD20), imaging‑confirmed disease required. Exclude: ECOG ≥2, pregnancy/lactation, active CNS disease, major cardiac issues, HIV/active HBV/HCV, uncontrolled infection, active malignancies, serious neuro disorders. Allo‑HCT ok if >3 mo/no GVHD, prior CD19 Rx allowed if CD19+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: 19(T2)28z1xx TRAC CAR T cells—an autologous, gene-edited cellular therapy. The CAR targets CD19 using a CD28 costimulatory domain and CD3ζ signaling with a “1XX” ITAM-modulated ζ chain to tune activation. The CAR is inserted into the T-cell receptor alpha constant (TRAC) locus, knocking out the endogenous TCR to standardize CAR expression and reduce tonic signaling/GvHD risk. Mechanism of action: engineered T cells bind CD19 on B cells, trigger CD28/ζ signaling, and kill malignant cells, with 1XX designed to limit exhaustion and enhance persistence. Targets: CD19+ malignant B cells (DLBCL/HGBCL/PMBCL), T-cell activation pathways (Lck–ZAP70–NFAT/NF-κB).