Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV) (SOUNDTRACK-C1)

May 28, 2026 updated by: AstraZeneca

A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Not yet recruiting
        • Research Site
      • Fitzroy, Australia, 3065
        • Not yet recruiting
        • Research Site
      • Heidelberg, Australia, 3084
        • Not yet recruiting
        • Research Site
      • Nedlands, Australia, 6009
        • Recruiting
        • Research Site
      • Perth, Australia, 6847
        • Not yet recruiting
        • Research Site
      • Rockingham, Australia, 6168
        • Not yet recruiting
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Not yet recruiting
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Not yet recruiting
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Not yet recruiting
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Not yet recruiting
        • Research Site
      • Toronto, Ontario, Canada, M5G 2L7
        • Recruiting
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Not yet recruiting
        • Research Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Not yet recruiting
        • Research Site
      • Québec, Quebec, Canada, G1J 1Z4
        • Not yet recruiting
        • Research Site
  • Turkey (Türkiye)
      • Adapazarı, Turkey (Türkiye), 54100
        • Not yet recruiting
        • Research Site
      • Antalya, Turkey (Türkiye), 07025
        • Recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34899
        • Not yet recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34098
        • Not yet recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34517
        • Not yet recruiting
        • Research Site
      • Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • Research Site
      • Mezitli, Turkey (Türkiye), 33200
        • Recruiting
        • Research Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Not yet recruiting
        • Research Site
      • Hampshire, United Kingdom, SO16 6YD
        • Not yet recruiting
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Not yet recruiting
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Not yet recruiting
        • Research Site
      • London, United Kingdom, NW1 2BU
        • Not yet recruiting
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Not yet recruiting
        • Research Site
      • Oxford, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Surovatamig
Surovatamig will be administered as a subcutaneous injection.
Other Names:
  • TNB-486
  • AZD0486
Experimental: DOSRI-Surovatamig Dose 2
Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).
Drug: Surovatamig
Surovatamig will be administered as a subcutaneous injection.
Other Names:
  • TNB-486
  • AZD0486
Experimental: Phase III-Arm A: Surovatamig SC
Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).
Drug: Surovatamig
Surovatamig will be administered as a subcutaneous injection.
Other Names:
  • TNB-486
  • AZD0486
No Intervention: Phase III-Arm B: Observation
Participants will undergo observation for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Parexel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2026

Primary Completion (Estimated)

August 29, 2031

Study Completion (Estimated)

April 5, 2032

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7409C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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