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Surovatamig作为慢性淋巴细胞白血病或小淋巴细胞淋巴瘤伴未突变免疫球蛋白重链可变区（IGHV）参与者的巩固疗法 (SOUNDTRACK-C1)

2026年10月5日 更新者：AstraZeneca

一项针对IGHV未突变慢性淋巴细胞白血病或小淋巴细胞淋巴瘤患者一线诱导治疗后，比较Surovatamig巩固治疗与观察的III期、随机、开放标签、多中心研究（SOUNDTRACK-C1）

The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a Phase III global, randomised, open-label, multicentre study. The study will consist of 2 sequential parts- the Dose Optimisation and Safety Run-in part and the Phase-III part.

During the dose optimisation and safety run-in part, Surovatamig will be initiated in 2 dose levels. This part will help to determine the recommended phase III dose (RP3D) of Surovatamig to be used in Phase III part. Phase III would comprise of 2 arms, Arm A where the Surovatamig dose (RP3D) will be administered as a consolidation therapy (post standard of care [SOC] induction therapy) and Arm B where participants will be observed. In Phase 3 participants will be randomized in a 1:1 ratio to Arm A or Arm B.

研究类型

介入性

注册 (估计的)

420

阶段

  • 第三阶段

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 5G2
        • 招聘中
        • Research Site
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E6
        • 暂停
        • Research Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
        • 招聘中
        • Research Site
    • Ontario
      • Hamilton、Ontario、加拿大、L8V 5C2
        • 尚未招聘
        • Research Site
      • Toronto、Ontario、加拿大、M5G 2L7
        • 招聘中
        • Research Site
    • Quebec
      • Montreal、Quebec、加拿大、H3T 1E2
        • 招聘中
        • Research Site
      • Montreal、Quebec、加拿大、H2L 4M1
        • 暂停
        • Research Site
      • Québec、Quebec、加拿大、G1J 1Z4
        • 暂停
        • Research Site
  • 土耳其（türkiye）
      • Adapazarı、土耳其（türkiye）、54100
        • 招聘中
        • Research Site
      • Antalya、土耳其（türkiye）、07025
        • 招聘中
        • Research Site
      • Istanbul、土耳其（türkiye）、34098
        • 尚未招聘
        • Research Site
      • Istanbul、土耳其（türkiye）、34899
        • 招聘中
        • Research Site
      • Istanbul、土耳其（türkiye）、34517
        • 招聘中
        • Research Site
      • Kocaeli、土耳其（türkiye）、41380
        • 招聘中
        • Research Site
      • Mezitli、土耳其（türkiye）、33200
        • 招聘中
        • Research Site
  • 澳大利亚
      • Adelaide、澳大利亚、5000
        • 招聘中
        • Research Site
      • Fitzroy、澳大利亚、3065
        • 尚未招聘
        • Research Site
      • Heidelberg、澳大利亚、3084
        • 招聘中
        • Research Site
      • Nedlands、澳大利亚、6009
        • 招聘中
        • Research Site
      • Perth、澳大利亚、6847
        • 招聘中
        • Research Site
      • Rockingham、澳大利亚、6168
        • 尚未招聘
        • Research Site
  • 美国
    • California
      • La Jolla、California、美国、92093
        • 尚未招聘
        • Research Site
    • Colorado
      • Denver、Colorado、美国、80218
        • 尚未招聘
        • Research Site
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • 尚未招聘
        • Research Site
    • Illinois
      • Chicago、Illinois、美国、60637
        • 尚未招聘
        • Research Site
    • Kansas
      • Kansas City、Kansas、美国、66210
        • 尚未招聘
        • Research Site
    • Kentucky
      • Louisville、Kentucky、美国、40207
        • 尚未招聘
        • Research Site
    • Maryland
      • Bethesda、Maryland、美国、20817
        • 尚未招聘
        • Research Site
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 尚未招聘
        • Research Site
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 尚未招聘
        • Research Site
    • New Jersey
      • Basking Ridge、New Jersey、美国、07920
        • 尚未招聘
        • Research Site
    • New York
      • Rochester、New York、美国、14642
        • 尚未招聘
        • Research Site
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 尚未招聘
        • Research Site
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • 尚未招聘
        • Research Site
    • Texas
      • Houston、Texas、美国、77030
        • 尚未招聘
        • Research Site
  • 英国
      • Edinburgh、英国、EH4 2XU
        • 招聘中
        • Research Site
      • Hampshire、英国、SO16 6YD
        • 招聘中
        • Research Site
      • Leeds、英国、LS9 7TF
        • 尚未招聘
        • Research Site
      • London、英国、SE5 9RS
        • 招聘中
        • Research Site
      • London、英国、NW1 2BU
        • 招聘中
        • Research Site
      • Manchester、英国、M20 4BX
        • 招聘中
        • Research Site
      • Nottingham、英国、NG5 1PB
        • 招聘中
        • Research Site
      • Oxford、英国、OX3 7LE
        • 招聘中
        • Research Site
      • Sutton、英国、SM2 5PT
        • 招聘中
        • Research Site

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

18年 至 18年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV.
  • Treatment received and response at the end of 1L (first-line) finite therapy.
  • Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion.
  • ECOG performance status of 0 to 2.
  • Adequate haematologic, liver, renal and cardiac function.
  • Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception.
  • Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms).

Exclusion Criteria:

  • Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL).
  • Evidence of active or history of Central Nervous System (CNS) involvement by CLL/SLL.
  • History of or ongoing confirmed progressive multifocal leukoencephalopathy.
  • Participants who have any concurrent or history of malignancy.
  • Participants with:
  • Active or uncontrolled infection (including Epstein-Barr virus-EBV) requiring systemic therapy.
  • Participants with known history of Heamophagocytic lymphohistiocytosis (HLH).
  • Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
  • Major cardiac abnormalities.
  • Prior CLL/SLL-specific therapies.
  • Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition or prior allogeneic stem cell or solid organ transplant.
  • Major surgical procedure.
  • Known hypersensitivity to surovatamig or any of the excipients of the product.

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：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：Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1

Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).
药品：Surovatamig

Surovatamig will be administered as a subcutaneous injection.

其他名称：
  • TNB-486
  • AZD0486
实验性的：DOSRI-Surovatamig Dose 2

Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).
药品：Surovatamig

Surovatamig will be administered as a subcutaneous injection.

其他名称：
  • TNB-486
  • AZD0486
实验性的：Phase III-Arm A: Surovatamig SC

Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).
药品：Surovatamig

Surovatamig will be administered as a subcutaneous injection.

其他名称：
  • TNB-486
  • AZD0486
无干预：Phase III-Arm B: Observation

Participants will undergo observation for 24 weeks.

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
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
大体时间：Up to 5 years

To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
Up to 5 years
Phase III- Progression Free Survival (PFS)
大体时间：Until disease progression or death (up to 5 years)

PFS is defined as the time from date of randomisation until disease progression or death due to any cause, whichever occur first based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria, as assessed by independent review committee (IRC).
Until disease progression or death (up to 5 years)
DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs
大体时间：Up to 5 years

To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
Up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Objective Response Rate (ORR)
大体时间：Up to 5 years

ORR is defined as the proportion of participants achieving either a partial response (PR) or complete response (CR)/complete response with incomplete haematological recovery (CRi) based on response criteria iwCLL 2018, as assessed by IRC or investigator at any point during therapy/observation.
Up to 5 years
Complete Response rate (CR rate)
大体时间：Up to 5 years

CR rate is defined as the proportion of participants achieving a CR or CRi as best response based on response criteria for iwCLL 2018.
Up to 5 years
Duration of response (DoR)
大体时间：Up to 5 years

The DoR is defined as the time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018.
Up to 5 years
DOSRI- PFS
大体时间：Until disease progression or death (up to 5 years)

PFS for Safety Run-in phase is defined as the time from first dose until the date of documented progression or death due to any cause whichever comes first, based on iwCLL 2018 criteria.
Until disease progression or death (up to 5 years)
Overall Survival (OS)
大体时间：Up to 5 years

OS is defined as the time from first dose until death due to any cause.
Up to 5 years
Serum concentrations of Surovatamig
大体时间：At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)

To characterise the serum concentration of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)
Maximum concentration observed (Cmax)
大体时间：At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)

To characterise the pharmacokinetics (PK) of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Time to Maximum Concentration (tmax)
大体时间：At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)

To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Trough concentration (Ctrough)
大体时间：At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)

To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Number of participants with Anti-drug antibodies (ADA)
大体时间：At predefined intervals from the date of first dose to approximately 5 years

DOSRI- To evaluate the immunogenicity of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.

Phase III- To determine the immunogenicity of SC surovatamig in CLL/SLL participants with uIGHV.
At predefined intervals from the date of first dose to approximately 5 years
Phase III- PFS
大体时间：Until disease progression or death (up to 5 years)

PFS is defined as the time from date of randomisation until disease progression or death due to any cause , whichever comes first based on iwCLL 2018 criteria, as assessed by investigator.
Until disease progression or death (up to 5 years)
Phase III- Number of participants with AEs and SAEs
大体时间：Up to 5 years

To assess safety and tolerability of SC surovatamig compared to observation in CLL/SLL participants with uIGHV.
Up to 5 years

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

AstraZeneca

合作者

Parexel

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 (实际的)

2026年5月5日

初级完成 (估计的)

2031年8月29日

研究完成 (估计的)

2032年4月5日

研究注册日期

首次提交

2026年3月27日

首先提交符合 QC 标准的

2026年3月27日

首次发布 (实际的)

2026年4月3日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月5日

最后验证

2026年10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

  • D7409C00001

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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

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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