Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
报名条件（概要）
- 年龄：18 Years – 不限
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
United States
药品与企业信息
Cohort A Eligible subjects will receive the anti-CD40 antibody 2141-V11 administered by intravesical instillation once weekly for 3 consecutive weeks (weeks 1, 2, and 3) for a total of 3 doses. As discussed further below, depending on disease status at week 13 and week 25 evaluations, subjects may be eligible for re-treatment (once weekly for 3 doses) at these time points.
Cohort B Part 1 Eligible subjects will receive the anti-CD40 antibody 2141-V11 administered by intratumoral injection once every 3 weeks (weeks 1, 4, 7, and 10) for a total of 4 doses. As discussed further below, depending on disease status at week 14 and week 26 evaluations, subjects may be eligible for re-treatment (once every 3 weeks for a total of 4 doses) at these time points.
Cohort C Eligible subjects will receive the anti-CD40 antibody 2141-V11 administered by intratumoral injection as a single 10mg during standard of care cystoscopy and examination no sooner than 22 days of the last cycle of neoadjuvant therapy with enfortumab vedotin and pembrolizumab and prior to and within 4 weeks of planned radical cystectomy.
Cohort B Part 2 is a nonblinded, randomized prospective trial to determine whether the combination of gemcitabine with 2141-V11 is more efficacious than gemcitabine monotherapy in patients with BCG-naïve HG Ta NMIBC
Cohort B Part 2 is a nonblinded, randomized prospective trial to determine whether the combination of gemcitabine with 2141-V11 is more efficacious than gemcitabine monotherapy in patients with BCG-naïve HG Ta NMIBC
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
合作机构
- Pin Down Bladder Cancer Research FoundationUNKNOWN
- Rockefeller University研究机构/其他
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Bernard Bochner, MDbochnerb@mskcc.org646-422-4387
- Eugene Pietzak, MD646-422-4781
研究中心联系方式
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge，New Jersey，United States
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown，New Jersey，United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale，New Jersey，United States
- Memorial Sloan Kettering Commack (Limited Protocol Activities)Commack，New York，United States
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison，New York，United States
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York，New York，United States
问自己是否符合条件、如何预筛
我的病情档案
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment ClinicalTrials.gov Identifier: NCT05126472 Sponsor: Memorial Sloan Kettering Cancer Center Investigational product: anti-CD40 antibody 2141-V11, anti-CD40 antibody 2141-V11, anti-CD40 antibody 2141-V11, Intravesical Gemcitabine, Intravesical Gemcitabine with anti-CD40 antibody 2141-V11 About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment 试验编号：NCT05126472 申办方：Memorial Sloan Kettering Cancer Center 研究药物：anti-CD40 antibody 2141-V11、anti-CD40 antibody 2141-V11、anti-CD40 antibody 2141-V11、Intravesical Gemcitabine、Intravesical Gemcitabine with anti-CD40 antibody 2141-V11 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。