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eligibility_summary
Adults (≥18) with hematologic disease hospitalized for an approved CAR‑T cell infusion at the Departmental Program of Advanced Cellular Therapies, IRCCS AOU of Bologna, who provide written informed consent. No specific exclusions listed.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial type: Observational. Population: Adults receiving approved anti‑CD19 CAR‑T therapies. Drugs/interventions: Second‑generation CAR‑T cell products (autologous, genetically engineered T‑lymphocyte therapy, “living drug”): tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel (lisocabtagene maraleucel anticipated). Mechanism of action: Patient T cells are transduced to express a chimeric antigen receptor that binds CD19 on B cells, triggering HLA‑independent activation and cytotoxic killing, expected on‑target effects include B‑cell aplasia, risks include CRS and ICANS. Targets (cells/pathways): CD19+ malignant B cells, assessment of tumor resistance (e.g., antigen loss/alteration) via ctDNA VAF kinetics, immune microenvironment via single‑cell RNA‑seq of peripheral blood CAR+ and CAR− T‑cell subsets and myeloid cells, mapping cytokine/inflammatory pathways and cellular states linked to efficacy and toxicity.