eligibility_summary
Eligibility: Consent, ECOG 0-1, histologically confirmed LBCL, FL, MCL, or indolent lymphoma transformed to DLBCL with CD19 and/or CD20, at least 1 measurable lesion (Lugano: nodal >1.5 cm, extranodal >1.0 cm). Exclude prior CAR or other gene-modified cell therapy, ongoing/expected need for systemic steroids (except inhaled/local), unstable heart disease (e.g., recent MI <6 mo, NYHA >=III CHF, severe arrhythmia).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: UTAA09 injection, a biological, gene‑modified cellular immunotherapy composed of CD19‑CAR γδ T cells (single IV dose, 3×10^8–1×10^10 cells). Mechanism of action: γδ T lymphocytes are engineered with a chimeric antigen receptor that recognizes CD19 on B cells, CAR engagement activates γδ T‑cell cytotoxicity, inducing lysis of CD19+ malignant B cells and expected on‑target depletion of normal CD19+ B cells. Targets: CD19 on B‑cell non‑Hodgkin lymphomas (DLBCL, follicular lymphoma, mantle cell lymphoma, and transformed indolent lymphoma). Pathways/cells affected: CD19‑mediated tumor targeting, CAR‑driven T‑cell activation and effector killing by γδ T cells, peripheral CD19+ B‑cell counts assessed as a pharmacodynamic marker.