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/ Not yet recruitingPhase 1 NMM肿瘤治疗性DNA疫苗裸质粒注射液在晚期实体瘤患者和复发、难治性淋巴瘤患者中的安全性、耐受性的Ia/Ib 期临床研究
[Translation] Phase Ia/Ib clinical study on the safety and tolerability of NMM tumor therapeutic DNA vaccine naked plasmid injection in patients with advanced solid tumors and relapsed and refractory lymphoma
Ia剂量递增阶段:
主要目的:
(1)评估NMM肿瘤治疗性DNA疫苗裸质粒注射液在晚期实体瘤患者和复发/难治性淋巴瘤患者中的安全性和耐受性;
(2)确定剂量限制性毒性(DLT)和最大耐受剂量(MTD),推荐II期临床试验剂量(RP2D)。
次要目的:
评价NMM肿瘤治疗性DNA疫苗裸质粒注射液在晚期实体瘤患者和复发、难治性淋巴瘤患者中的初步疗效。
Ib量扩展阶段:
主要目的:
评估NMM肿瘤治疗性DNA疫苗裸质粒注射液在晚期黑色素瘤、晚期乳腺癌患者和复发/难治性淋巴瘤患者中的安全性和剂量耐受性,并确定RP2D。
次要目的:
进一步评价NMM肿瘤治疗性DNA疫苗裸质粒注射液在晚期黑色素瘤、晚期乳腺癌患者和复发、难治性淋巴瘤患者中的初步疗效。
探索性目的:
探索NMM肿瘤治疗性DNA疫苗裸质粒注射液在晚期黑色素瘤、晚期乳腺癌患者和复发、难治性淋巴瘤患者治疗前后生物标志物较基线期变化规律。
[Translation] Phase Ia dose escalation phase:
Main objectives:
(1) To evaluate the safety and tolerability of NMM tumor therapeutic DNA vaccine naked plasmid injection in patients with advanced solid tumors and relapsed/refractory lymphoma;
(2) To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the Phase II clinical trial dose (RP2D).
Secondary objectives:
To evaluate the preliminary efficacy of NMM tumor therapeutic DNA vaccine naked plasmid injection in patients with advanced solid tumors and relapsed and refractory lymphoma.
Phase Ib dose expansion phase:
Main objectives:
To evaluate the safety and dose tolerance of NMM tumor therapeutic DNA vaccine naked plasmid injection in patients with advanced melanoma, advanced breast cancer and relapsed/refractory lymphoma, and to determine RP2D.
Secondary objectives:
To further evaluate the preliminary efficacy of NMM tumor therapeutic DNA vaccine naked plasmid injection in patients with advanced melanoma, advanced breast cancer and relapsed and refractory lymphoma.
Exploratory purpose:
To explore the changes in biomarkers compared with the baseline period before and after treatment with NMM tumor therapeutic DNA vaccine naked plasmid injection in patients with advanced melanoma, advanced breast cancer, and relapsed and refractory lymphoma.
100 Clinical Results associated with Beijing Zhendan Dingtai Biotechnology Co., Ltd.
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100 Translational Medicine associated with Beijing Zhendan Dingtai Biotechnology Co., Ltd.