Resimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma
Resimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma
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DOI：
10.3324/haematol.2015.123711
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发表时间：
2015-06-01
期刊：
影响因子：
10.1
通讯作者：
Neville, David M.
中科院分区：
文献类型：
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作者：
Frankel, Arthur E.;Woo, Jung H.;Neville, David M.
Resimmune是第二代重组免疫毒素，由白喉毒素的催化和易位结构域与两个与CD 3+胞外结构域反应的单链抗体片段融合组成。在一项患者间剂量递增试验中，我们对30名患者（25名皮肤T细胞淋巴瘤患者，3名外周T细胞淋巴瘤患者，1名T细胞大颗粒淋巴细胞白血病患者和1名T细胞幼淋巴细胞白血病患者）在15分钟内静脉输注2.5 - 11.25 μ g/kg的瑞舒命。最常见的不良事件为发热、寒战、低血压、水肿、低白蛋白血症、低磷血症和转氨酶血症。在25例皮肤T细胞淋巴瘤患者中，有9例缓解，缓解率为36%（95% CI，18%-57%），其中4例完全缓解（16%，95% CI，5%-36%）。完全缓解的持续时间为72+、72+、60+和38+个月。有5例部分缓解持续3、3、3+、6+和14个月。在17名具有改良皮肤加权评估工具评分的患者中
Resimmune is a second-generation recombinant immunotoxin composed of the catalytic and translocation domains of diphtheria toxin fused to two single chain antibody fragments reactive with the extracellular domain of CD3 epsilon. We gave intravenous infusions of Resimmune 2.5 - 11.25 mu g/kg over 15 minutes to 30 patients (25 with cutaneous T-cell lymphoma, 3 with peripheral T-cell lymphoma, 1 with T-cell large granular lymphocytic leukemia and 1 with T-cell prolymphocytic leukemia) in an inter-patient dose escalation trial. The most common adverse events were fever, chills, hypotension, edema, hypoalbuminemia, hypophosphatemia, and transaminasemia. Among the 25 patients with cutaneous T-cell lymphoma, there were nine responses for a response rate of 36% (95% CI, 18%-57%) including four complete remissions (16%, 95% CI, 5%-36%). The durations of the complete remissions were 72+, 72+, 60+ and 38+ months. There were five partial remissions lasting 3, 3, 3+, 6+ and 14 months. Of 17 patients with a modified skin weighted assessment tool score