eligibility_summary
Eligibility: ≥18, ECOG 0–1, CD19+ DLBCL/FL/MCL/MZL with active disease, adequate organs, allo‑SCT >6 mo with no GVHD/immunosupp. Failed/ineligible for CAR‑T plus R/R after ≥2 lines or auto/allo SCT, subtype: FL early relapse, MCL/MZL BTKi. Exclusions: active infection (HBV/HCV), NYHA III/IV or unstable arrhythmia, active GVHD or steroid/immunosuppression dependence, prior huCART19‑IL18, active CNS disease, pregnancy/lactation, immune CNS/optic neuritis, autoimmune disease on ≥10 mg prednisone.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05989204 tests TmCD19-IL18, an autologous, genetically engineered CAR T-cell therapy (“armored” CAR) for relapsed/refractory CD19+ non-Hodgkin lymphomas. Drug type: biological cellular therapy. Mechanism: patient T cells are modified to express an anti-CD19 CAR for antigen-specific recognition and killing of malignant B cells, while co-expressing and secreting human IL-18 to boost CAR-T expansion/persistence and create a Th1-skewed, proinflammatory microenvironment (enhancing IFN-γ, and activating NK cells and macrophages). Targets: CD19 on B-cell malignancies, immune pathways include CAR signaling (CD3ζ/costimulation) in T cells and IL-18/IL-18R signaling (NF-κB/AP-1) in T, NK, and myeloid cells. Single IV infusion with 3+3 dose escalation.