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PURPOSE: MT-3724, a novel engineered toxin body comprised of an anti-CD20 single-chain variable fragment genetically fused to Shiga-like Toxin A subunit, is capable of binding to and internalizing against CD20, inducing cell killing via permanent ribosomal inactivation. This study evaluated MT-3724 in patients with relapsed/refractory B-cell Non-Hodgkin lymphoma (r/rNHL). METHODS: This open-label, multiple-dose Phase 1a/b trial included a dose escalation in patients with r/rNHL according to a standard 3+3 design. Primary objectives were to determine the maximum tolerated dose (MTD) and pharmacokinetics/pharmacodynamics. In a dose expansion study at MTD in serum rituximab-negative patients with diffuse large B-cell lymphoma (DLBCL), primary objectives were safety, tolerability, and pharmacokinetics/pharmacodynamics. RESULTS: Twenty-seven patients enrolled. MTD was 50 µg/kg/dose with 6000 µg/dose cap. Thirteen patients experienced at least one Grade ≥3 treatment-related adverse events; the most common Grade ≥3 event was myalgia (11.1%). Two patients (75 µg/kg/dose) experienced Grade 2 treatment-related capillary leak syndrome. Overall objective response rate was 21.7%. In serum rituximab-negative patients with DLBCL or composite DLBCL (n=12), overall response rate was 41.7% (complete response, n=2; partial response, n=3). In patients with detectable baseline peripheral B-cells, treatment resulted in dose-dependent B-cell depletion. The proportion of patients with anti-drug antibodies (ADAs) increased during treatment and the majority appeared to be neutralizing based on an in vitro assay; nevertheless, tumor regression and responses were observed. CONCLUSIONS: MT-3724 demonstrated efficacy at the MTD in this population of previously treated patients with r/rDLBCL, with mild-to-moderate immunogenic safety events.

Safety and Efficacy of Engineered Toxin Body MT-3724 in Relapsed or Refractory B-cell Non-Hodgkin's Lymphomas and Diffuse Large B-cell Lymphoma