NCT06566547进行中（未招募）2 期
Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- ORR evaluated by IRC
研究概览
简要总结
All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be measurable by central laboratory assessment: Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
- •Light chain multiple myeloma without measurable disease in the serum or the urine:
- •Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
排除标准
- •1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
研究组 & 干预措施
GR1803
Experimental
干预措施: GR1803 injection (Drug)
结局指标
主要结局
ORR evaluated by IRC
时间窗: 2 years
Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
次要结局
- ORR evaluated by investigator(2 years)
- Progression-free survival (PFS) evaluated by IRC(2 years)
- MRD negative rate(2 years)
- AE(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Study to Evaluate GR1801's Efficacy and SafetyRabies Post-exposure ProphylaxisNCT05846568Genrix (Shanghai) Biopharmaceutical Co., Ltd.1,200
招募中
1 期
A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT06590246Shanghai AbelZeta Ltd.121
终止
1 期
Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) PatientsCastrate Resistant Prostate CancerNCT01352208Astellas Pharma Inc13
招募中
2 期
Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TBNCT02354014Janssen Research & Development, LLC60
招募中
3 期
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA TherapyGEP-NETGastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine Tumor DiseaseNeuroendocrine TumorsCarcinoid TumorPancreatic NETCarcinoidNCT05477576RayzeBio, Inc.288