NCT05092347进行中（未招募）1 期
A Dose Escalation and Proof-of-Concept Study of Vonsetamig (BCMA × CD3 Bispecific Antibody) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 10
- 主要终点
- Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period
研究概览
简要总结
The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation.
Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA.
The study is looking at several other research questions, including:
- Side effects that may be experienced from taking vonsetamig
- How vonsetamig works in the body
- How much vonsetamig is present in the blood
- If vonsetamig works to lower levels of antibodies to HLA
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA >98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist, as defined in the protocol
- •Adequate hematologic and adequate hepatic function as defined in the protocol
- •Willing and able to comply with clinic visits and study-related procedures
排除标准
- •Current or active malignancy not in remission for at least 1 year
- •Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
- •Patients who have had their spleen removed, including patients with functional asplenia
- •Patients who have received a stem cell transplantation within 5 years
- •Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
- •Total plasma IgG <300 mg/dL at screening
- •Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration
- •Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
- •Received cyclophosphamide, rituximab, obinutuzumab, other anti-CD20 or B cell-depleting agents, or proteasome inhibitors or anti-CD38 therapies (eg, isatuximab, daratumumab) within 12 months of study drug administration
- •Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bsAb) or BCMA-directed CAR-T cell therapy, as described in the protocol
- •Has received a COVID-19 vaccination, as described in the protocol
- •Note: Other protocol defined inclusion / exclusion criteria apply
研究组 & 干预措施
Vonsetamig
Experimental
干预措施: Vonsetamig (Drug)
结局指标
主要结局
Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period
时间窗: Up to approximately 6 weeks
Incidence and severity of treatment-emergent adverse events (TEAE)s from the first study drug dose up to the end of the study
时间窗: Up to 78 weeks
TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)
次要结局
- Percent change from baseline in the peak (immunodominant) MFI(Up to 78 weeks)
- Time to first clinically meaningful reduction in anti-HLA alloantibody levels by SAB assay(Up to 78 weeks)
- Duration of maximal reduction in anti-HLA alloantibody MFI by SAB assay(Up to 78 weeks)
- Time to maximal reduction in cPRA from baseline(Up to 78 weeks)
- Percent change from baseline in the sum of MFI of anti-HLA alloantibodies using the SAB assay(Up to 78 weeks)
- Maximum reduction in cPRA from baseline(Up to 78 weeks)
- Duration of a reduction in peak anti-HLA alloantibody to MFI <5,000 or by ≥50% by SAB assay(Up to 78 weeks)
- Percent change from baseline of serum concentration of Ig classes(Up to 78 weeks)
- Duration of maximal reduction in cPRA by SAB assay(Up to 78 weeks)
- Serum concentration of Immunoglobulin (Ig) classes over time(Up to 78 weeks)
- Concentration of vonsetamig in serum over time(Up to 78 weeks)
- Incidence of treatment-emergent anti-drug antibodies (ADAs) to vonsetamig over time(Up to 78 weeks)
- Proportion of Participants with a clinically meaningful reduction in anti-HLA alloantibodies(Up to 78 weeks)
- Maximum reduction in the peak (immunodominant) MFI of anti-HLA alloantibodies from baseline(Up to 78 weeks)
- Time to maximal reduction in anti-HLA alloantibody levels by SAB assay(Up to 78 weeks)
- Time to first clinically meaningful reduction in cPRA(Up to 78 weeks)
研究者
研究点 (10)
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