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For patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), who have already failed ibrutinib therapy, CD19-targeted chimeric antigen receptor-engineered T-cells (CAR T) could enable durable response to therapy.
In a pilot phase I/II study (NCT01865617) conducted by Jordan Gauthier, Fred Hutchinson Cancer Research Center, Seattle, US, and colleagues, the safety and efficacy of ibrutinib plus CD19 CAR T infusion was evaluated in patients with R/R CLL, who had previously failed ibrutinib therapy. The primary goal of this trial was to investigate a potential synergistic association between ibrutinib and CAR T therapy, with the hope of improving outcomes for patients with R/R CLL. Results showed that ibrutinib may improve CAR T cell anti-tumor efficacy and could also reduce the risk of cytokine release syndrome (CRS).
During the study, 19 patients with R/R CLL were enrolled. The median number of prior therapies was 5 (range, 1–10), with 17 patients (89%) having high-risk cytogenetics (17p deletion and/or complex karyotype and/or 11q abnormalities). All enrolled patients had previously failed ibrutinib treatment.
Ibrutinib (420mg, daily) was administered to patients, along with a defined composition of 2x105 or 2x106/kg CD4+ and CD8+ CD19 CAR T cells after lymphodepletion chemotherapy. Ibrutinib was scheduled from < 2 weeks before leukapheresis, and up to > 3 months after CAR T infusion.
As results of the study showed that CD19 CAR T-cell therapy combined with ibrutinib led to high rates of durable responses without > grade 3 CRS, the research team concluded that that this combination would be a reasonable choice in patients with R/R CLL. In a previous study, Marie Kersten, from the Academic Medical Center, Amsterdam, NL, found that CAR T therapy lead to durable remissions in patients with DLBCL, and was a feasible treatment option. Below, Renier Brentjens speaks about the latest advances in CAR T-cell therapy.
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