eligibility_summary
Eligible: R/R B‑ALL (Ph‑ after ≥1 multiagent, Ph+ after ≥1 2nd/3rd‑gen TKI), consent, age ≥17 initially then ≥12, CD19+ if prior anti‑CD19, allo‑HSCT ≥3 mo w/o GVHD, DLI ≥4 wks, non‑isolated, asymptomatic CNS ok, adequate organs, ECOG 0–1/Lansky≥60, prior CD19 Tx allowed. Exclude: other active malignancy (except low‑risk localized), Burkitt’s/CML‑LBC, CNS3/symptomatic CNS, recent steroids/chemo, major cardiac, autoimmune/GVHD Tx, HIV/HBV/HCV, uncontrolled infection/COVID, live vax <4 wks, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06287528 tests 19-28z/IL-18, an autologous CD19-directed CAR T-cell therapy (biological, gene‑modified cellular immunotherapy). The CAR uses a CD19 scFv with CD28/CD3ζ signaling (“28z”) and is engineered to constitutively secrete interleukin‑18. Arms dose 0.5–1×10^6 CAR T cells/kg with or without lymphodepleting chemotherapy. Mechanism: CAR engagement of CD19 on B‑ALL blasts activates T cells via CD28/CD3ζ to kill malignant B cells. Secreted IL‑18 acts on IL‑18 receptors on T cells, NK cells, and myeloid cells to amplify Th1/IFN‑γ responses, enhance cytotoxicity, proliferation, and persistence, and reshape the tumor microenvironment. Targets/pathways: CD19 on leukemic B‑cell precursors, CAR/T-cell activation (CD28/CD3ζ), IL‑18/IL‑18R signaling, downstream IFN‑γ axis, effects on T cells, NK cells, and macrophages.