Application of antiCD19 CAR T lymphocytes for the treatment of adult patients with B-cell acute lymphoblastic leukemia with resistance, relapse or detectable measurable residual disease. Phase I/II clinical trial (MERMAID1)

B-cell acute lymphoblastic leukemia. with resistance, relapse or detectable measurable residual disease

Overall response rate (ORR) to treatment, defined as complete remission (CR) and complete remission with incomplete haematopoietic recovery (CRi), Percentage of patients with treatment-emergent adverse event (TEAE) Grade ≥ 3 within 12 weeks after treatment of therapies of particular interest, i.e.: o Cytokine Release Syndrome (CRS)o Neurological Adverse Events (ICANS) o Infections o Febrile neutropenia o Persistent cytopenias (i.e. more than 28 days after CAR T cell administration) o Tumor lysis syndrome (TLS)

Percentage of patients with SAE during the observation period, taking into account their severity and the causal relationship with the applied treatment, Disease-free percentage at 1, 3, 6, 12, 18 and 24 months post-infusion ie complete remission (CR) or complete remission with incomplete haematopoietic recovery (CRi) with negative minimal residual disease (MRD-) cytometrically assessed, Progression-Free Survival (PFS); Time from CAR-T infusion to relapse or death from any cause, Overall Survival (OS); Time from CAR-T infusion to death from any cause, Cmax; cellular kinetics of CAR-T - maximum expression observed in peripheral blood after a single administration (% copies/µg) over 24 months of observation, Tmax; CAR-T cellular kinetics - time to maximum copy number in peripheral blood after a single administration (days) over 24 months of observation, AUC0-30d and 90d; CAR-T cellular kinetics - AUC from day 0 to day 30 and 90 or other days as assessed in peripheral blood (% copies/µg x days), AUC0-Tmax; CAR-T cellular kinetics - AUC from day 0 to Tmax in peripheral blood (% copies/µg/days), Percentage of patients enrolled in the study for whom the CAR-T product was manufactured, Duration of response (time from finding CR or CRi to patient progression or death from any cause), Percentage of CR or CRi patients with persistent B-cell aplasia after CAR-T cell infusion over 24 months of follow-up. Absolute CD19(+) lymphocyte count < 50/µl

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