eligibility_summary
Adults (≥18) with relapsed/refractory B‑cell cancers: DLBCL/HGBL: ≥2 regimens (or ≥1 if HDCT/ASCR‑ineligible), CLL: ≥2 incl. BTKi, MCL: ≥2 incl. chemoimmunotherapy+BTKi, FL: ≥2. Cohort rules for prior/eligibility for CD19 CAR‑T, prior CD19 allowed if CD19+ confirmed. Need PET‑avid measurable disease (DLBCL biopsy), ECOG 0–1, adequate organ function, contraception, consent. Exclude pregnancy, cardiac disease, active GVHD/autoimmune on T‑cell suppression, HIV, active HBV/HCV, uncontrolled infection, other active cancer, CNS/neuro disease, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06343376 (Phase I): Tests EGFRt/19-28z/IL-12 CAR T cells, an autologous gene-modified cellular therapy. Drug/intervention: EGFRt/19-28z/IL-12 CAR T-lymphocytes (anti‑CD19 CAR with CD28 costimulatory and CD3ζ signaling domains) engineered to secrete IL‑12, includes truncated EGFR (EGFRt) tag for cell tracking and potential cetuximab-mediated depletion (safety switch). Cohort B also receives lymphodepletion: cyclophosphamide (alkylating agent) and fludarabine (purine analog). Mechanisms: CAR engagement of CD19 triggers T-cell activation via CD28/CD3ζ, IL‑12 promotes Th1 polarization, IFN‑γ production, and activation of innate cells to enhance anti-tumor activity. Targets: CD19+ malignant B cells (on-target B-cell aplasia expected), pathways include CAR signaling and IL‑12/STAT4 axis. Indications: R/R DLBCL/HGBL, FL, MCL, CLL. Status: terminated (manufacturing issues).