Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHVPhase 3SOUNDTRACK-C1NCT07509151
Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
A Phase 3 study testing Surovatamig in people with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV, run by AstraZeneca at 44 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV
- What is being tested?
- Surovatamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 44 sitesin 5 countries
- Study dates
- 5 May 2026to 5 Apr 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
44 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
44 sites in 5 countries
United States14 sites, 14 recruiting
- Not yet recruiting
Research Site
Basking Ridge, New Jersey, 07920
- Not yet recruiting
Research Site
Bethesda, Maryland, 20817
- Not yet recruiting
Research Site
Boston, Massachusetts, 02215
- Not yet recruiting
Research Site
Chicago, Illinois, 60637
- Not yet recruiting
Research Site
Cleveland, Ohio, 44195
- Not yet recruiting
Research Site
Denver, Colorado, 80218
- Not yet recruiting
Research Site
Houston, Texas, 77030
- Not yet recruiting
Research Site
Kansas City, Kansas, 66210
- Not yet recruiting
Research Site
La Jolla, California, 92093
- Not yet recruiting
Research Site
Louisville, Kentucky, 40207
- Not yet recruiting
Research Site
New Haven, Connecticut, 06510
- Not yet recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Not yet recruiting
Research Site
Rochester, Minnesota, 55905
- Not yet recruiting
Research Site
Rochester, New York, 14642
United Kingdom9 sites, 9 recruiting
- Recruiting
Research Site
Edinburgh, EH4 2XU
- Recruiting
Research Site
Hampshire, SO16 6YD
- Not yet recruiting
Research Site
Leeds, LS9 7TF
- Recruiting
Research Site
London, NW1 2BU
- Recruiting
Research Site
London, SE5 9RS
- Recruiting
Research Site
Manchester, M20 4BX
- Recruiting
Research Site
Nottingham, NG5 1PB
- Recruiting
Research Site
Oxford, OX3 7LE
- Recruiting
Research Site
Sutton, SM2 5PT
Canada8 sites, 5 recruiting
- Recruiting
Research Site
Calgary, Alberta, T2N 5G2
- Recruiting
Research Site
Halifax, Nova Scotia, B3H 2Y9
- Not yet recruiting
Research Site
Hamilton, Ontario, L8V 5C2
- Suspended
Research Site
Montreal, Quebec, H2L 4M1
- Recruiting
Research Site
Montreal, Quebec, H3T 1E2
- Suspended
Research Site
Québec, Quebec, G1J 1Z4
- Recruiting
Research Site
Toronto, Ontario, M5G 2L7
- Suspended
Research Site
Vancouver, British Columbia, V5Z 4E6
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Research Site
Adapazarı, 54100
- Recruiting
Research Site
Antalya, 07025
- Not yet recruiting
Research Site
Istanbul, 34098
- Recruiting
Research Site
Istanbul, 34517
- Recruiting
Research Site
Istanbul, 34899
- Recruiting
Research Site
Kocaeli, 41380
- Recruiting
Research Site
Mezitli, 33200
Australia6 sites, 6 recruiting
- Recruiting
Research Site
Adelaide, 5000
- Not yet recruiting
Research Site
Fitzroy, 3065
- Recruiting
Research Site
Heidelberg, 3084
- Recruiting
Research Site
Nedlands, 6009
- Recruiting
Research Site
Perth, 6847
- Not yet recruiting
Research Site
Rockingham, 6168
About this study
Official title: 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).
Read the 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.
- Being tested
- Surovatamig
- Keywords
- Leukaemia, Lymphoma, Monoclonal IgG4 antibody, Consolidation therapy, Therapeutic benefit, Induction therapy, B-cell malignancy
- Medical subject headings
- Leukemia, B-Cell, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurovatamigDrug
Also called TNB-486, AZD0486
Surovatamig will be administered as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1 | Experimental | Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length). Receives: Drug: Surovatamig |
| DOSRI-Surovatamig Dose 2 | Experimental | Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length). Receives: Drug: Surovatamig |
| Phase III-Arm A: Surovatamig SC | Experimental | Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length). Receives: Drug: Surovatamig |
| Phase III-Arm B: Observation | No intervention | Participants will undergo observation for 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: Up to 5 years
Phase III- Progression Free Survival (PFS)
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).
Measured: 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
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.
Measured: Up to 5 years
Secondary outcomes (12)
Objective Response Rate (ORR)
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.
Measured: Up to 5 years
Complete Response rate (CR rate)
CR rate is defined as the proportion of participants achieving a CR or CRi as best response based on response criteria for iwCLL 2018.
Measured: Up to 5 years
Duration of response (DoR)
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.
Measured: Up to 5 years
DOSRI- PFS
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.
Measured: Until disease progression or death (up to 5 years)
Overall Survival (OS)
OS is defined as the time from first dose until death due to any cause.
Measured: Up to 5 years
Serum concentrations of Surovatamig
To characterise the serum concentration of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Measured: At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)
Maximum concentration observed (Cmax)
To characterise the pharmacokinetics (PK) of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Measured: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Time to Maximum Concentration (tmax)
To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Measured: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Trough concentration (Ctrough)
To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Measured: 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)
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.
Measured: At predefined intervals from the date of first dose to approximately 5 years
Phase III- PFS
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.
Measured: Until disease progression or death (up to 5 years)
Phase III- Number of participants with AEs and SAEs
To assess safety and tolerability of SC surovatamig compared to observation in CLL/SLL participants with uIGHV.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start5 May 2026
- Primary completion29 Aug 2031 (estimated)
- Study completion5 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHVStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509151
- Sponsor's protocol ID
- D7409C00001
- Acronym
- SOUNDTRACK-C1
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07509151
- Acronym / sponsor ID
- SOUNDTRACK-C1 / D7409C00001
- Keywords
- Leukaemia, Lymphoma, Monoclonal IgG4 antibody, Consolidation therapy, Therapeutic benefit, Induction therapy, B-cell malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 5 May 2026 (actual)
- Primary completion
- 29 Aug 2031 (estimated)
- Study completion
- 5 Apr 2032 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1 | Experimental | Drug: SurovatamigParticipants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length). |
| DOSRI-Surovatamig Dose 2 | Experimental | Drug: SurovatamigParticipants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length). |
| Phase III-Arm A: Surovatamig SC | Experimental | Drug: SurovatamigParticipants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length). |
| Phase III-Arm B: Observation | No intervention | –Participants will undergo observation for 24 weeks. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurovatamigAlso: TNB-486, AZD0486Surovatamig will be administered as a subcutaneous injection. | Drug | DOSRI-Surovatamig Dose 2, Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1, Phase III-Arm A: Surovatamig SC |
Primary outcome
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.
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).
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.
12 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 5 years
Complete Response rate (CR rate)
Time frame: Up to 5 years
Duration of response (DoR)
Time frame: Up to 5 years
DOSRI- PFS
Time frame: Until disease progression or death (up to 5 years)
Overall Survival (OS)
Time frame: 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)
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)
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)
Trough concentration (Ctrough)
Time frame: 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
Phase III- PFS
Time frame: Until disease progression or death (up to 5 years)
Phase III- Number of participants with AEs and SAEs
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
44 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surovatamig in people with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV, run by AstraZeneca at 44 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, United Kingdom, Canada, Turkey (Türkiye), Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.