ZUMA-1 (NCT02348216) is a prospective, interventional and first multicenter, pivotal trial of an autologous anti-CD19 CAR T cell therapy, axicabtagene ciloleucel (axi-cel, formerly KTE-C19), in patients with refractory, aggressive NHL. Axi-cel treatment resulted in an ORR of 82% and a...
Eighty recent-onset type 1 diabetes patients participated in the placebo-controlled otelixizumab (GSK; NCT00627146) trial. Hyperglycemic clamps were performed at baseline, 6, 12 and 18 months, involving 3 h of induced euglycemia, followed by acutely raising and maintaining glycemia to ≥ 10 mmol...
https://clinicaltrials.gov/ct2/show/NCT02684357 18. Rentz AM, Skalicky AM, Burslem K, et al. The content validity of the PSS in patients with plaque psoriasis. J Patient Rep Outcomes. 2017;1(1):4. doi:10.1186/s41687-017-0004-7PubMedGoogle ScholarCrossref 19. ...
NCT05690035 /Withdrawn临床2期IIT PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial This is an open-label phase II study, with the aim of investiga...
Ⅱ期临床试验(NCT01030861)中,Tzield(teplizumab)组中有75%的患者出现淋巴细胞减少症,给药105天后,淋巴细胞数量恢复到正常范围;36%的患者出现自发消退性皮疹。给药组与安慰剂组出现感染的发生率相近。 2023年3月13日,赛诺菲(Sanofi)和Provention Bio联合宣布,两者达成协议,赛诺菲将斥资近29亿美元收购Provention,并...
PROMISE-1是一项随机,双盲,多中心,安慰剂对照研究(NCT02559895),成人(18-75岁)具有大于12个月的偏头痛病史,每月头痛次数≤14天(其中≥4天为偏头痛)接受eptinezumab 30、100、300 mg或安慰剂每3个月1次,共12个月(n =888)。在研究期间,患者可以使用并发急性偏头痛药物(例如曲普坦,麦角-胺衍生物)。相对于...
teplizumab的BLA,基于TrialNet开展的TN-10研究(“At-Risk”,NCT01030861)的临床数据。该研究评估了teplizumab用于高危群体预防或延缓发生临床1型糖尿病(T1D)的疗效和安全性。结果显示,与安慰剂相比,单个为期2周(14天)疗程的teplizumab治疗显著推迟了高危儿童和成人临床T1D的发病和诊断时间,T1D发病率降低50%,发...
Tzield的安全性和有效性在一项针对76名2期1型糖尿病患者的随机、双盲、事件驱动、安慰剂对照试验（NCT01030861）中进行了评估。在试验中，患者每天通过静脉输注随机接受Tzield或安慰剂一次，持续14天。疗效的主要衡量指标是从随机分配到进行3期1型糖尿病诊断的时间。试验结果显示，在51个月的中位随访期间，接受Tzi...
Tzield(teplizumab)的安全性和有效性在一项针对76名2期1型糖尿病患者的随机、双盲、安慰剂对照试验(NCT01030861)中进行了评估。在试验中,患者每天通过静脉输注随机接受Tzield(teplizumab)或安慰剂一次,持续14天。疗效的主要衡量指标是从随机分配到进...
NCT06796803 /Not yet recruiting临床2/3期IIT Camrelizumab and Rivoceranib Plus HAIC As Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2/3 Study The purpose of this phase 2/3 study is to investigate the eff...