NCT06413511撤回1 期
A Phase 1b, Dose Escalation, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Participants With Autoimmune Disease
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 16
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with stable but active autoimmune disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) from 18 to 40 kilograms per square meter (kg/m^2) (BMI = weight/height^2), inclusive, and body weight of >=40 kilogram (kg)
- •IgM >= lower limit of normal (LLN) (40 milligram per deciliter [mg/dL]) at initial screening visit (ISV)
- •Participants with systemic lupus erythematosus (SLE) must also meet the following inclusion criteria:
- •Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria
- •Positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibody and/or positive antinuclear antibody (ANA) test results, using central lab test, at ISV.
- •SLE Disease Activity Index 2000 (SLEDAI-2K) total score of >=6 at ISV.
- •Failure to adequately respond to at least two immunosuppressive therapies.
- •Participants with Rheumatoid Arthritis (RA) must also meet the following inclusion Criteria:
- •Meets ACR/EULAR 2010 RA Classification Criteria with a duration of RA disease of >=6 months at time of ISV
- •Positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) test results, using central lab test, at ISV.
- •Have moderate to severe active disease as defined by >=3/68 Tender and >=3/66 Swollen joint count at ISV and Baseline.
- •Failure to adequately respond to at least two immunosuppressive therapies.
- •Participants with antiphospholipid syndrome (APS) must also meet the following inclusion criteria:
- •Documented diagnosis of APS meeting the 2023 ACR/EULAR APS classification criteria
- •Positive lupus anticoagulant test or moderate to high titers of positive IgG/IgM anticardiolipin (aCL) or moderate to high titers of IgG/IgM anti-beta2-glycoprotein I antibody using central lab test, at ISV
- •Clinical features attributable to antiphospholipid antibodies that are resistant to warfarin and/or heparin:
- •Thrombotic event within last 18 months despite adequate anti-coagulation therapy and/or
- •Persistent thrombocytopenia and/or
- •Persistent autoimmune hemolytic anemia
- •Sex and Contraceptive /Barrier requirements for females.
- •Exclusion criteria:
- •SLE specific exclusion:
- •Any acute, severe lupus related flare during the Screening Period that needs immediate treatment
- •Has any unstable or progressive manifestation of SLE
- •Significant, likely irreversible organ damage related to SLE
- •RA specific exclusions:
- •RA functional status class IV according to the ACR 1991 revised criteria
- •Adult Juvenile RA
- •APS specific exclusions:
- •Acute thrombosis (arterial or venous acute thrombosis diagnosis) less than 30 days before study ISV
- •Catastrophic APS classification within the prior 90 days of ISV
排除标准
- 未提供
研究组 & 干预措施
Belantamab
Experimental
干预措施: Belantamab (Biological)
结局指标
主要结局
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to Week 12
Number of participants with clinically important findings in urinalysis parameters
时间窗: Up to Week 12
Number of participants with clinically important findings in vital signs
时间窗: Up to Week 12
Number of participants with clinically important findings in echocardiogram
时间窗: Up to Week 12
Number of participants with clinically important findings in hematology
时间窗: Up to Week 12
Number of participants with clinically important findings in clinical chemistry
时间窗: Up to Week 12
Number of participants with clinically important findings in electrocardiogram
时间窗: Up to Week 12
Number of participants with clinically important finding in corneal toxicity
时间窗: Up to Week 12
次要结局
- Change from Baseline in Immunoglobulin (Ig) M (IgM)(Baseline (Day 1) and up to Week 12)
- Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab(Up to 12 weeks)
- Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab(Up to 12 weeks)
- Maximum observed plasma drug concentration [Cmax] of belantamab(Up to 12 weeks)
- Number of participants with Anti-Drug Antibodies (ADAs) against belantamab(Up to 12 weeks)
- Titers of ADAs against belantamab(Up to 12 weeks)
研究者
相似试验
已完成
1 期
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)Multiple MyelomaNCT03544281GlaxoSmithKline153
已完成
1 期
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)NCT03340766Amgen31
已完成
1 期
A Study of MGD013 in Patients With Unresectable or Metastatic NeoplasmsAdvanced Solid TumorsHematologic NeoplasmsHER2-positive Advanced Solid TumorsNon Small Cell Lung CancerSmall-cell Lung CancerOvarian CancerSquamous Cell Carcinoma of Head and NeckTNBC - Triple-Negative Breast CancerCervical CancerCholangiocarcinomaNCT03219268MacroGenics277
Unknown
1 期
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple MyelomaRelapsed or Refractory Multiple MyelomaNCT04798586Pfizer4
已完成
1 期
A Study of AMG 757 in Participants With Neuroendocrine Prostate CancerNeuroendocrine Prostate CancerNCT04702737Amgen41