Phase 2 study of the infusion of differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001 cells) in patients with CD19+ acute lymphoid leukemia resistant or refractory to therapy

Acute lymphoid leukemia

Response rate with measurable residual disease negative by multiparametric flow cytometry 28 days after infusion of ARI-0001 cells.

Duration of response, Best response during the first 3 months of follow-up after administration of the first fractioned dose of ARI-0001, Progression-free survival at 6 months and 1 year of the infusion and after the signature of informed consent., Overall Survival (OS) at 1 year of the infusion and after the informed consent form signature, Assessment of ARI-0001 cell toxicity considering special interest in the following adverse events: CRS (cytokine release syndrome), encephalopathy associated with CARs (ICANS) and cerebral edema. Mortality related to study procedures and adverse events grade 3-4 will be evaluated at month 3 and year 1. Intensity will be assessed using CTCAE version 5.0 scale. To evaluate CRS and neurotoxicity ASTCT criteria will be used., In vivo survival of ARI-0001 cells in peripheral blood, bone narrow and cerebrospinal fluid, to be determined by flow cytometry and quantitative transgene PCR with monthly frequency in the first 6 months and thereafter quarterly up to 2 years of infusion

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