eligibility_summary
Eligibility: Adults (>18) with CD19+ or CD269+ R/R aggressive B-cell lymphoma (Burkitt, rare histologies not covered by CART19, or R/R after CART19). ECOG 0-2, life expectancy >=3 months, apheresis access, consent, if prior anti-CD19/-CD269, tumor must express >=1 target. Exclude: recent experimental therapy, other active cancer, immunosuppression, active infection (HBV/HCV/HIV), major organ dysfunction, pregnancy/no contraception, CNS mass lesions, isolated meningeal OK.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: ARI0003, an autologous gene‑modified cellular immunotherapy (CAR T cells). Patient T cells are expanded and co‑transduced by lentiviral vectors to express two chimeric antigen receptors: anti‑CD19 and anti‑BCMA (CD269). Mechanism of action: Upon binding CD19 or BCMA on malignant B cells/plasmablastic cells, the dual CARs activate T‑cell effector functions (cytotoxicity and cytokine release) to kill tumor cells. Dual targeting is intended to prevent/overcome antigen escape after prior CD19‑directed therapy. Target cells/pathways: CD19+ B‑cell lineage malignancies and BCMA+ plasmablastic/plasma‑cell–like components, BCMA (TNFRSF17) is part of the BAFF/APRIL survival axis. Trial: Early Phase 1, single‑arm, first‑in‑human in relapsed/refractory aggressive B‑cell lymphoma (including post‑CART19 failure), ARI0003 given IV in split doses (total 0.5–5×10^6 cells/kg).