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Chronic Lymphocytic LeukaemiaPhase 1/2Soundtrack-ENCT06564038

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

A Phase 1/2 study testing Surovatamig, Prednisone (or equivalent) and Rituximab in people with Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma, run by AstraZeneca at 65 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surovatamig, Prednisone (or equivalent) and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
65 sitesin 13 countries
Study dates
30 Jan 2025to 11 Jun 2029
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Master Inclusion Criteria applicable to all substudies:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Contraception use during treatment and at least 90 days after final dose.
  • Confirmed CD19 expression if prior anti-CD19 therapy.
  • Substudy 1 Specific Inclusion Criteria:
  • Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
Show all 28Show fewer
  • SLL: at least 1 measurable site per Lugano.
  • Absolute lymphocyte count (ALC) <25000 cells/mcL.
  • Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
  • Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.
  • Substudy 2 Specific Inclusion Criteria:
  • MCL diagnosis per WHO.
  • Clinical Stage II, III, or IV by Ann Arbor Classification.
  • At least 1 measurable site per Lugano.
  • ALC < 25000 cells/mcL.
  • Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
  • Substudy 3 Specific Inclusion Criteria:
  • At least 1 measurable site as per Lugano.
  • Left ventricular ejection fraction (LVEF) ≥50%.
  • Participant must be no older than 79 years of age at the time of signing ICF.
  • Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
  • Cohort 3A:
  • Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
  • R/R B-NHL after at least 1 prior lines of systemic therapy.
  • International Prognostic Index (IPI) 2-5.
  • Cohort 3B:
  • Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
  • IPI score of 2 to 5.

Who cannot join

  • Master Exclusion Criteria applicable to all substudies:
  • Central nervous system (CNS) lymphoma.
  • Surgery within 14 days of study drug.
  • Clinically significant cardiovascular (CV) disease.
  • Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
  • Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
Show all 17Show fewer
  • Radiation therapy within 28 days.
  • Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
  • Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
  • Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
  • Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).
  • Substudy 1 Specific Exclusion Criteria:
  • CLL/SLL transformation to more aggressive form of lymphoma.
  • Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.
  • Substudy 3 Specific Exclusion Criteria:
  • Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
  • Cumulative dose of anthracycline >150 mg/m2.

Trial locations and contacts

65 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

65 sites in 13 countries

United States13 sites, 12 recruiting

  • Research Site

    Boston, Massachusetts, 02215

    Recruiting

  • Research Site

    Charlotte, North Carolina, 28204

    Recruiting

  • Research Site

    Charlotte, North Carolina, 28204

    Not yet recruiting

  • Research Site

    Columbus, Ohio, 43210

    Recruiting

  • Research Site

    Hackensack, New Jersey, 07601

    Recruiting

  • Research Site

    Houston, Texas, 77030

    Not yet recruiting

  • Research Site

    New Brunswick, New Jersey, 08901

    Recruiting

  • Research Site

    New York, New York, 10029

    Recruiting

  • Research Site

    New York, New York, 10065

    Withdrawn

  • Research Site

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Research Site

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Research Site

    Portland, Oregon, 97239

    Recruiting

  • Research Site

    Providence, Rhode Island, 02903

    Recruiting

Other trials in United States

Germany6 sites, 6 recruiting

  • Research Site

    Cologne, 50937

    Not yet recruiting

  • Research Site

    Homburg, 66421

    Not yet recruiting

  • Research Site

    Kiel, 24105

    Recruiting

  • Research Site

    Mainz, 55131

    Not yet recruiting

  • Research Site

    München, 81377

    Recruiting

  • Research Site

    Würzburg, 97080

    Recruiting

Other trials in Germany

South Korea6 sites, 6 recruiting

  • Research Site

    Busan, 48108

    Recruiting

  • Research Site

    Seoul, 02841

    Recruiting

  • Research Site

    Seoul, 03080

    Recruiting

  • Research Site

    Seoul, 05505

    Recruiting

  • Research Site

    Seoul, 06351

    Recruiting

  • Research Site

    Seoul, 06591

    Recruiting

Other trials in South Korea

Spain6 sites, 6 recruiting

  • Research Site

    Barcelona, 8036

    Recruiting

  • Research Site

    Madrid, 28034

    Recruiting

  • Research Site

    Madrid, 28040

    Recruiting

  • Research Site

    Palma de Mallorca, 7120

    Recruiting

  • Research Site

    Santiago de Compostela, 15706

    Recruiting

  • Research Site

    Valencia, 46026

    Recruiting

Other trials in Spain

China5 sites, 4 recruiting

  • Research Site

    Beijing, 100044

    Recruiting

  • Research Site

    Guangzhou, 510060

    Recruiting

  • Research Site

    Jinan, 250013

    Withdrawn

  • Research Site

    Tianjin, 300060

    Recruiting

  • Research Site

    Zhengzhou, 450008

    Recruiting

Other trials in China

France5 sites, 5 recruiting

  • Research Site

    Clermont-Ferrand, 63000

    Not yet recruiting

  • Research Site

    Montpellier, 34295

    Recruiting

  • Research Site

    Paris, 75010

    Recruiting

  • Research Site

    Saint-Cloud, 92210

    Recruiting

  • Research Site

    Villejuif, 94805

    Recruiting

Other trials in France

Denmark4 sites, 4 recruiting

  • Research Site

    Aalborg, 9000

    Recruiting

  • Research Site

    Aarhus N, 8200

    Recruiting

  • Research Site

    Copenhagen, 2100

    Recruiting

  • Research Site

    Odense C, 5000

    Recruiting

Other trials in Denmark

Taiwan4 sites, 4 recruiting

  • Research Site

    Changhua, 500

    Recruiting

  • Research Site

    Kaohsiung City, 83301

    Recruiting

  • Research Site

    Tainan, 710

    Recruiting

  • Research Site

    Taipei, 100

    Recruiting

Other trials in Taiwan

United Kingdom4 sites, 4 recruiting

  • Research Site

    Derriford, PL6 5FP

    Recruiting

  • Research Site

    London, SE5 9RS

    Recruiting

  • Research Site

    Oxford, 0X3 7LJ

    Recruiting

  • Research Site

    Southampton, SO16 6YD

    Recruiting

Other trials in United Kingdom

Australia3 sites, 3 recruiting

  • Research Site

    Heidelberg, 3084

    Recruiting

  • Research Site

    Melbourne, 3004

    Recruiting

  • Research Site

    Nedlands, 6009

    Recruiting

Other trials in Australia

Czechia3 sites, 3 recruiting

  • Research Site

    Ostrava - Poruba, 708 52

    Recruiting

  • Research Site

    Prague, 12808

    Recruiting

  • Research Site

    Praha 2 - Nové Město, 12820

    Recruiting

Other trials in Czechia

Italy3 sites, 3 recruiting

  • Research Site

    Bologna, 40138

    Not yet recruiting

  • Research Site

    Milan, 20141

    Not yet recruiting

  • Research Site

    Milan, 20162

    Not yet recruiting

Other trials in Italy

Japan3 sites, 3 recruiting

  • Research Site

    Kōtoku, 135-8550

    Recruiting

  • Research Site

    Matsuyama, 791-0280

    Recruiting

  • Research Site

    Nagoya, 464-8681

    Recruiting

Other trials in Japan

About this study

Official title: A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies

Read the detailed description

This is open-label, multi-center study to evaluate the safety and preliminary efficacy of surovatamig administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies.

This master study currently includes 3 substudies and each substudy focusing on a defined population:

Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic lymphoma (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US)

The study will have the following sequential periods:

  1. Screening period of 28 days
  2. Treatment period
  3. Follow-up period
Being tested
Surovatamig, Prednisone (or equivalent), Rituximab, Cyclophosphamide, Vincristine
Keywords
IgG4 fully human CD19xCD3 bispecific T-cell engager, B cell lymphoma, Subcutaneous, Acalabrutinib, Prednisone, Rituximab, Cyclophosphamide, Vincristine, Doxorubicin, Surovatamig
Medical subject headings
Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurovatamigDrug

    Also called AZD0486, TNB-486

    Surovatamig will be administered as either SC injection or IV infusion.

  • Prednisone (or equivalent)Drug

    Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.

  • RituximabDrug

    Rituximab will be administered as IV infusion as per standard of care.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered as IV infusion as per standard of care.

  • VincristineDrug

    Vincristine will be administered as IV infusion as per standard of care.

  • DoxorubicinDrug

    Doxorubicin will be administered as IV infusion as per standard of care.

  • AcalabrutinibDrug

    Acalabrutinib will be administered orally

Study groups in NCT06564038
Study groupRoleWhat they receive
Substudy 1 (RR CLL/SLL): Cohort 1A (Surovatamig Monotherapy)ExperimentalParticipants will receive surovatamig monotherapy as subcutaneous (SC) injection.
Receives: Drug: Surovatamig
Substudy 1 (RR CLL/SLL): Cohort 1B (Surovatamig + Acalabrutinib)ExperimentalParticipants will receive surovatamig as SC injection. Participants will receive acalabrutinib tablet orally twice daily.
Receives: Drug: Surovatamig; Drug: Acalabrutinib
Substudy 1 (RR CLL/SLL): Cohort 1C (Surovatamig Monotherapy)ExperimentalParticipants will receive surovatamig monotherapy as intravenous (IV) infusion.
Receives: Drug: Surovatamig
Substudy 2 (RR MCL): Cohort 2A (Surovatamig Monotherapy)ExperimentalParticipants will receive surovatamig monotherapy as SC injection.
Receives: Drug: Surovatamig
Substudy 2 (RR MCL): Cohort 2C (Surovatamig Monotherapy)ExperimentalParticipants will receive surovatamig monotherapy as IV infusion.
Receives: Drug: Surovatamig
Substudy 3 (LBCL): Cohort 3A 2SUD (Surovatamig + RCHOP)ExperimentalParticipants will receive surovatamig as IV infusion with a 2SUD (double step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Receives: Drug: Surovatamig; Drug: Prednisone (or equivalent); Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin
Substudy 3 (LBCL): Cohort 3B 3SUD (Surovatamig + RCHOP)ExperimentalParticipants will receive surovatamig as IV infusion with a 3SUD (triple step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Receives: Drug: Surovatamig; Drug: Prednisone (or equivalent); Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest

    Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.

    Measured: Up to 6 years 4 months

  2. Number of Participants with Dose Limiting Toxicity (DLTs)

    Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.

    Measured: Up to 2 months

Secondary outcomes (11)

  1. Overall Response Rate (ORR)

    ORR is defined as percentage of participants achieving either a partial response (PR) or complete response (CR) based on response criteria for International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving either PR or CR based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).

    Measured: Up to 6 years 4 months

  2. Complete Response (CR) Rate

    CR rate is defined as percentage of participants achieving CR as best response based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).

    Measured: Up to 6 years 4 months

  3. Duration of Response (DoR)

    DoR is defined as time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator, relapse or death (substudy 1) and time from the date of first documented response until date of documented progression based on Lugano 2014 Response Criteria by investigator assessment, relapse or death (substudies 2 and 3).

    Measured: Up to 6 years 4 months

  4. Maximum Observed Concentration (Cmax)

    The PK (Cmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

  5. Area Under the Concentration-time Curve (AUC)

    The PK (AUC) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

  6. Minimum Observed Concentration (Cmin)

    The PK (Cmin) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

  7. Time to Reach Maximum Concentration (tmax)

    The PK (tmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

  8. Trough Plasma Concentration (Ctrough)

    The PK (Ctrough) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

  9. Half Life (t1/2) of surovatamig

    The PK (t1/2) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

  10. Clearance (CL) of surovatamig

    The PK (CL) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

  11. Number of Participants with Anti-drug Antibody (ADA) for surovatamig

    The incidence of immunogenicity of SC surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

    Measured: Up to 90 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start30 Jan 2025
  3. Primary completion11 Jun 2029 (estimated)
  4. Study completion11 Jun 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564038
Sponsor's protocol ID
D7407C00001
Other IDs
2024-515034-33-00
Acronym
Soundtrack-E
Status last verified
Sep 2026
First submitted
19 Aug 2024
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
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 there quest 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 approved.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Surovatamig, Prednisone (or equivalent) and Rituximab in people with Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma, run by AstraZeneca at 65 sites in 13 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 28 inclusion and 17 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Germany, South Korea, Spain, China and 8 more countries. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (time frame: Up to 6 years 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06564038.

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 8 Sep 2026.

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