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Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer

2026年8月6日 更新者：Washington University School of Medicine

A Phase Ib Study Evaluating the Safety and Tolerability of Sipuleucel-T (Sip-T) in Combination With N-803 in Patients With Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer

This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients with metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Patients will receive treatment for up to 8 weeks.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Missouri
      • St Louis、Missouri、美国、63110
        • Washington University School of Medicine
        • 副研究员：
          • Jingqin Rosy Luo, Ph.D.
        • 接触：
        • 首席研究员：
          • Russell K Pachynski, M.D.
        • 副研究员：
          • Peter Oppelt, M.D.
        • 副研究员：
          • Eric Knoche, M.D.
        • 副研究员：
          • Melissa Reimers, M.D.
        • 副研究员：
          • Jade Tao, Ph.D.
        • 副研究员：
          • Mark Sundermeyer, M.D.
        • 首席研究员：
          • Daniel Thorek, Ph.D.
        • 副研究员：
          • John Visconti, D.O.
        • 副研究员：
          • Wilbur Song, M.D.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Histologically or cytologically confirmed prostate adenocarcinoma.
  • Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral).
  • Prior treatment must include either orchiectomy or luteinizing hormone-releasing agonist or antagonist treatment with documented testosterone ≤ 50 ng/dL.
  • Eligible for standard of care Sipuleucel-T.
  • Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy.
  • At least 18 years of age.
  • ECOG performance status ≤ 2

  • Adequate bone marrow and organ function as defined below:

    • Absolute neutrophil count ≥ 1,500 K/cumm without granulocyte colony-stimulating factor support
    • Platelets ≥ 100,000 K/cumm without transfusion
    • Hemoglobin ≥ 10.0 g/dL
    • Total bilirubin ≤ 1.5 x IULN
    • AST(SGOT) and ALT(SGPT) ≤ 2.5 x IULN
    • Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault
  • PSA ≤ 200 ng/mL.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Exclusion Criteria:

  • Rapidly progressing disease or symptomatic prostate cancer as assessed by the investigator.
  • Prior immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) within the 6 months prior to enrollment.
  • Prior systemic radiotherapy (such as Ra-223, Lu177-PSMA) within the 6 months prior to enrollment. Prior palliative radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed.
  • Prior exposure to Sipuleucel-T.
  • Ongoing systemic immune suppression (oral steroids equivalent to 10 mg daily prednisone or less are allowed; topical, inhaled, and intra-articular steroids are allowed).
  • Currently receiving any other investigational therapeutic or imaging agents.
  • Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or N-803 or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
  • HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
  • Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
  • History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
  • Uncontrolled infection with hepatitis A.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1: Dose level 0 Starting dose: N-803 + SIP-T
Patients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 15 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
生物：Sipuleucel-T
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
其他名称：
  • 普罗旺斯
  • 西普
生物：N803
N-803 is a biologic that is administered subcutaneously in the abdominal area.
实验性的：Cohort 1: Dose level -1: N-803 + SIP-T
Patients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 10 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
生物：Sipuleucel-T
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
其他名称：
  • 普罗旺斯
  • 西普
生物：N803
N-803 is a biologic that is administered subcutaneously in the abdominal area.
实验性的：Cohort 1: Dose level -2: N-803 + SIP-T
Patients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 6 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30.
生物：Sipuleucel-T
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
其他名称：
  • 普罗旺斯
  • 西普
生物：N803
N-803 is a biologic that is administered subcutaneously in the abdominal area.
实验性的：Cohort 2: N-803 + SIP-T
Patients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and recommended phase 2 dose (RP2D) of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day -5 or 5 days before first SIP-T dose.
生物：Sipuleucel-T
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
其他名称：
  • 普罗旺斯
  • 西普
生物：N803
N-803 is a biologic that is administered subcutaneously in the abdominal area.
实验性的：Cohort 3: N-803 + SIP-T
Patients will receive standard dose (>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and RP2D of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day 37.
生物：Sipuleucel-T
Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously.
其他名称：
  • 普罗旺斯
  • 西普
生物：N803
N-803 is a biologic that is administered subcutaneously in the abdominal area.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Frequency of dose-limiting toxicities (Cohort 1 only)
大体时间：Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 (total time up to 44 days)
As assessed via CTCAE v6.0. Dose limiting toxicities will be evaluated according to protocol.
Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 (total time up to 44 days)
Recommended Phase II Dose (RP2D) (Cohort 1 only)
大体时间：Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 for all participants in Cohort 1 (total time up to 44 days)
RP2D is defined as the highest dose of N-803 that has an overall DLT rate of less than 33% in total of 6 patients.
Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 for all participants in Cohort 1 (total time up to 44 days)
Number of severe (grade 3+) adverse events measured via CTCAE v6.0
大体时间：Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
Number and type of adverse events measured via CTCAE v6.0
大体时间：Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)
Start of treatment through 100 days after last dose of N-803 (total time up to 137 days)

次要结果测量

结果测量
措施说明
大体时间
PSA30 Response
大体时间：Start of treatment to completion of follow-up (up to 26 months)
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 30% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria.
Start of treatment to completion of follow-up (up to 26 months)
PSA50 Response
大体时间：Start of treatment to completion of follow-up (up to 26 months)
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 50% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria.
Start of treatment to completion of follow-up (up to 26 months)
PSA90 Response
大体时间：Start of treatment to completion of follow-up (up to 26 months)
PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 90% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria.
Start of treatment to completion of follow-up (up to 26 months)
Radiographic progression-free survival (PFS)
大体时间：Start of treatment to date of progression or death or last follow-up (up to 26 months)
rPFS is defined as the duration of time from start of treatment to time of radiographic progression by PCWG3 or time of death or last follow-up, the event that occurs first. Patients who have not experienced either event at the time of analysis will be censored at their last radiographic scan date. All radiographic response criteria are assessed per PCWG3 criteria.
Start of treatment to date of progression or death or last follow-up (up to 26 months)
Failure-free survival (FFS)
大体时间：Start of treatment to date of any progression events or last follow-up (up to 26 months)
Failure-free survival which is defined from date of treatment start to date of any progression events (radiographic progression, biochemical recurrence, or death, whichever is earlier) or date of last follow-up if experiencing no events
Start of treatment to date of any progression events or last follow-up (up to 26 months)
Time to next therapy (TTNT)
大体时间：Through completion of follow-up (up to 26 months)
Through completion of follow-up (up to 26 months)
Overall survival (OS)
大体时间：Start of treatment to death or last follow-up (up to 26 months)
Overall survival is defined as the date of treatment start to date of death or date of last follow-up.
Start of treatment to death or last follow-up (up to 26 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Washington University School of Medicine

合作者

ImmunityBio, Inc.
Dendreon

调查人员

  • 首席研究员：Russell K Pachynski, M.D.、Washington University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月30日

初级完成 (估计的)

2029年4月14日

研究完成 (估计的)

2031年1月31日

研究注册日期

首次提交

2026年8月6日

首先提交符合 QC 标准的

2026年8月6日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月6日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26-x147

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data that underlie the results reported will be available for investigators with approval by an independent review committee.

IPD 共享时间框架

Data will be made available beginning 9 months and ending 36 months following publication.

IPD 共享访问标准

Investigators who have approval to use the data by an independent review committee.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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