Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

Health ProfessionalsPatients

RecruitingLast updated: 17 April 2025

Soundtrack-E: This study is recruiting people with mature B-cell blood cancers to study how safe and effective a targeted therapy called AZD0486 is when given by itself and in combination with other treatmentsA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

Soundtrack-E

Clinical summary

Summary

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

  • Substudy 1: relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (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)

Specific eligibility criteria apply for each substudy with regards to prior treatment, so please speak with your doctor to see if you are eligible.

The study will have the following sequential periods: screening period of 28 days, treatment period, follow-up period.

Substudy 1 (people with R/R CLL/SLL) will have two treatment cohorts. Cohort 1A will receive AZD0486 targeted therapy by itself (monotherapy) as an injection under the skin (subcutaenous injection, or SC). Cohort 1B will receive AZD0486 as an SC injection plus acalabrutinib targeted therapy which will be given as an oral tablet twice daily.

Substudy 2 (R/R MCL) will have two treatment cohorts. Cohort 2A will receive AZD0486 monotherapy as a SC injection. Cohort 2B will receive AZD0486 as an SC injection plus acalabrutinib as an oral tablet twice daily.

Substudy 3 (LBCL) currentl only has one treatment cohort. Participants will receive AZD0486 as an IV infusion in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy as per standard of care. For people achieving complete or partial remission (CR or PR), AZD0486 will be administered every 3 weeks.

Eligibility

Inclusion

Master Inclusion Criteria applicable to all substudies:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Contraception during treatment and at least 6 months 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.
  • SLL: at least 1 measurable site per Lugano.
  • Absolute lymphocytes <10,000.
  • Cohort 1A: at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i).
  • Cohort 1B: at least 1 prior line of therapy and is 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 < 10,000.
  • Cohort 2A: Relapse or progressed after 2 or more lines of therapy including BTKi.
  • Cohort 2B: Relapse or progressed after 1 or more line of therapy, not including a BTKi.

Substudy 3 Specific Inclusion Criteria:

  • Large B-cell lymphoma per WHO 2022.
  • R/R B-NHL after at least 1 prior line of therapy.
  • International Prognostic Index (IPI) 2-5.
  • At least 1 measurable site as per Lugano.
  • Left ventricular ejection fraction (LVEF) >50%.
  • Contraception at least 12 months after last dose of R-CHOP or 6 months after last dose of AZD0486.

Exclusion

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 anticancer therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
  • Radiation therapy within 28 days.
  • Prior CAR-T or auto-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.

Substudy 1 Specific Exclusion Criteria:

  • CLL transformation to more aggressive lymphoma
  • Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 6 months, GI malabsorption, receiving vitamin K antagonist

Substudy 2 Specific Exclusion Criteria:

  • Cohort 2B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 6 months, 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific 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

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

HelpThis verification step helps prevent fraudulent transactions from automated software.
Submitting ... Please wait