eligibility_summary
Eligibility: Age 3–70, ECOG 0–2, life expectancy >12 wks, CD19+ relapsed/refractory B‑cell hematolymphatic malignancy, adequate organ function (Cr ≤1.5×ULN, LVEF ≥45%, SpO2 >91%, Tbili ≤1.5×ULN, ALT/AST ≤2.5×ULN), informed consent. Exclude: GVHD/immunosuppressants, recent other cancers (limited in‑situ exceptions), HBV/HCV/HIV/CMV/syphilis+, serious heart/systemic disease, active infection, pregnancy/plans, recent steroids, other trial <3 mo, CNS disease, investigator veto.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests UTAA09, an allogeneic off‑the‑shelf CAR‑γδ T‑cell therapy (biological, gene‑modified cells via lentiviral anti‑CD19 vector) for CD19+ relapsed/refractory B‑cell hematolymphatic malignancies. UTAA09 is infused IV after lymphodepletion with fludarabine (purine‑analog antimetabolite) and cyclophosphamide (alkylating agent). Mechanism: the engineered CAR recognizes CD19 on B cells, activating γδ T cells to kill targets through MHC‑independent cytotoxicity, in vivo expansion, persistence, and CD19+ cell reduction are assessed. Targets: CD19 antigen on malignant B cells, downstream CAR T‑cell activation pathways and resultant B‑cell depletion. Lymphodepletion drugs target host lymphocytes to facilitate CAR‑T engraftment/expansion.