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    • 7. 发明申请
    • METHODS FOR ADAPTIVE DESIGN OF A TREATMENT REGIMEN AND RELATED TREATMENTS
    • 治疗方案和相关治疗的自适应设计方法
    • WO2017161212A1
    • 2017-09-21
    • PCT/US2017/022849
    • 2017-03-16
    • JUNO THERAPEUTICS, INC.CONNOR, JasonQUINTANA, Melanie
    • CONNOR, JasonQUINTANA, MelanieLI, HeALBERTSON, Tina
    • G06F19/00
    • Provided herein are methods for adaptive design of a treatment regimen for treatment of subjects with a therapeutic agent. In some embodiments, the methods can determine the optimal dosing regimen, such as dose level and/or schedule to administer to a subject. In some embodiments, the methods can be used for determining dosing regimens in clinical trials, such as Phase I clinical trials. In some embodiments, one or more of or all of the steps of the method occur at an electronic device containing one or more processors and memory, such as implemented by a computer. Also provided are methods of administering a therapeutic agent to a subject in accord with an adaptive dosing regimen designed to identify an optimal dose and/or schedule of a therapeutic agent for treating a disease or condition.
    • 本文提供用于自适应设计用于用治疗剂治疗受试者的治疗方案的方法。 在一些实施方案中,所述方法可以确定最佳给药方案,例如给予对象的剂量水平和/或时间表。 在一些实施方案中,该方法可用于确定临床试验中的给药方案,例如I期临床试验。 在一些实施例中,该方法的一个或多个或全部步骤发生在包含一个或多个处理器和存储器的电子设备处,例如由计算机实现的。 还提供了根据设计用于鉴定用于治疗疾病或病症的治疗剂的最佳剂量和/或时间表的适应性给药方案向对象施用治疗剂的方法。
    • 8. 发明申请
    • METHODS FOR DETERMINING DOSING OF A THERAPEUTIC AGENT AND RELATED TREATMENTS
    • 确定治疗剂剂量和相关治疗的方法
    • WO2017161208A1
    • 2017-09-21
    • PCT/US2017/022844
    • 2017-03-16
    • JUNO THERAPEUTICS, INC.JI, Yuan
    • JI, YuanLI, He
    • G06F19/00
    • Provided herein are methods employing a toxicity and efficacy probability interval (TEPI) design for performing a clinical trial, such as a Phase I dose-finding trial. In some embodiments, the methods can be used in the dosing of subjects administered a therapy, such as adoptive cell therapy or other immunotherapy, where safety and efficacy data for a therapeutic agent can be observed in the same timeframe or period. In some embodiments, one or more of or all of the steps of the method occur at an electronic device containing one or more processors and memory, such as implemented by a computer. Also provided are methods of administering a therapeutic agent to a subject in accord with the dosing decisions.
    • 本文提供了采用毒性和效力概率区间(TEPI)设计进行临床试验(例如I期剂量发现试验)的方法。 在一些实施方案中,所述方法可以用于施用治疗的受试者的剂量,例如过继性细胞疗法或其他免疫疗法,其中治疗剂的安全性和有效性数据可以在相同的时间范围或时间段内观察到。 在一些实施例中,该方法的一个或多个或全部步骤发生在包含一个或多个处理器和存储器的电子设备处,例如由计算机实现的。 还提供了根据给药决定向受试者施用治疗剂的方法。
    • 9. 发明申请
    • METHODS AND COMPOSITIONS RELATED TO TOXICITY ASSOCIATED WITH CELL THERAPY
    • 与细胞疗法有关的毒性的方法和组合物
    • WO2017096331A1
    • 2017-06-08
    • PCT/US2016/064865
    • 2016-12-02
    • JUNO THERAPEUTICS, INC.FRED HUTCHINSON CANCER RESEARCH CENTER
    • LI, HeGILBERT, Mark J.MALONEY, DavidRIDDELL, Stanley R.TURTLE, Cameron J.
    • G01N33/68
    • G01N33/6863A61K39/0011A61K2039/5156A61K2039/5158G01N33/6866G01N33/6869
    • Provided are methods, kits and compositions related to toxicity associated with administration of cell therapy for the treatment of diseases or conditions, e.g., cancer, including methods for use in predicting and treating a toxicity. In some embodiments, the toxicity is a neurotoxicity or cytokine release syndrome (CRS), such as a severe neurotoxicity or a severe CRS. The methods generally involve detecting a parameter of a biomarker or individually a parameter of each biomarker in a panel of biomarkers, such as a concentration, amount or activity, and comparing the detected parameter to a reference value for the parameter to determine if the subject is at risk for developing the toxicity, such as neurotoxicity or CRS or severe neurotoxicity or severe CRS. In some embodiments, the methods further involve administering an agent or therapy for treating, ameliorating, preventing, delaying and/or attenuating the development of the toxicity, such as neurotoxicity or CRS, such as severe neurotoxicity or severe CRS.
    • 提供了涉及与施用细胞疗法以治疗疾病或病症(例如癌症)有关的毒性的方法,试剂盒和组合物,包括用于预测和治疗毒性的方法。 在一些实施方案中,毒性是神经毒性或细胞因子释放综合征(CRS),例如严重的神经毒性或严重的CRS。 该方法通常包括检测生物标志物的参数或单独检测生物标志物组(例如浓度,量或活性)中的每个生物标志物的参数,并将检测到的参数与参数的参考值比较以确定受试者是 处于产生毒性的风险中,例如神经毒性或CRS或严重神经毒性或严重CRS。 在一些实施方案中,所述方法还包括施用用于治疗,改善,预防,延迟和/或减轻毒性发展的药剂或疗法,所述毒性例如神经毒性或CRS,例如严重的神经毒性或严重的CRS。