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

NCT ID: NCT06564038

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2028-02-28

Brief Summary

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

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Detailed Description

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This is open-label, multi-center study to evaluate the safety and preliminary efficacy of AZD0486 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

Conditions

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Chronic Lymphocytic Leukaemia Small Lymphocytic Lymphoma Mantle-cell Lymphoma Large B-cell Lymphoma B-cell Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Substudy 1 (RR CLL/SLL): Cohort 1A (AZD0486 Monotherapy)

Participants will receive AZD0486 monotherapy as subcutaneous (SC) injection.

Group Type EXPERIMENTAL

AZD0486

Intervention Type DRUG

AZD0486 will be administered as either SC injection or IV infusion.

Substudy 1 (RR CLL/SLL): Cohort 1B (AZD0486 + Acalabrutinib)

Participants will receive AZD0486 as SC injection. Participants will receive acalabrutinib tablet orally twice daily.

Group Type EXPERIMENTAL

AZD0486

Intervention Type DRUG

AZD0486 will be administered as either SC injection or IV infusion.

Acalabrutinib

Intervention Type DRUG

Acalabrutinib will be administered orally

Substudy 1 (RR CLL/SLL): Cohort 1C (AZD0486 Monotherapy)

Participants will receive AZD0486 monotherapy as intravenous (IV) infusion.

Group Type EXPERIMENTAL

AZD0486

Intervention Type DRUG

AZD0486 will be administered as either SC injection or IV infusion.

Substudy 2 (RR MCL): Cohort 2A (AZD0486 Monotherapy)

Participants will receive AZD0486 monotherapy as SC injection.

Group Type EXPERIMENTAL

AZD0486

Intervention Type DRUG

AZD0486 will be administered as either SC injection or IV infusion.

Substudy 2 (RR MCL): Cohort 2C (AZD0486 Monotherapy)

Participants will receive AZD0486 monotherapy as IV infusion.

Group Type EXPERIMENTAL

AZD0486

Intervention Type DRUG

AZD0486 will be administered as either SC injection or IV infusion.

Substudy 3 (LBCL): AZD0486 + R-CHOP

Participants will receive AZD0486 as IV infusion in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.

Group Type EXPERIMENTAL

AZD0486

Intervention Type DRUG

AZD0486 will be administered as either SC injection or IV infusion.

Prednisone (or equivalent)

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Vincristine

Intervention Type DRUG

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

Doxorubicin

Intervention Type DRUG

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

Interventions

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AZD0486

AZD0486 will be administered as either SC injection or IV infusion.

Intervention Type DRUG

Prednisone (or equivalent)

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

Intervention Type DRUG

Rituximab

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Vincristine

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

Intervention Type DRUG

Doxorubicin

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

Intervention Type DRUG

Acalabrutinib

Acalabrutinib will be administered orally

Intervention Type DRUG

Other Intervention Names

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TNB-486 Surovatamig

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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 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.


* 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 and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.


* 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 90 days after last dose of AZD0486 or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.

Exclusion Criteria

* 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-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.


* CLL transformation to more aggressive lymphoma.
* Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.


* Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
* Cumulative dose of anthracycline \>150 mg/m2.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Research Site

Hackensack, New Jersey, United States

Site Status NOT_YET_RECRUITING

Research Site

New Brunswick, New Jersey, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status NOT_YET_RECRUITING

Research Site

Charlotte, North Carolina, United States

Site Status RECRUITING

Research Site

Charlotte, North Carolina, United States

Site Status NOT_YET_RECRUITING

Research Site

Columbus, Ohio, United States

Site Status NOT_YET_RECRUITING

Research Site

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

Research Site

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Research Site

Pittsburgh, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Research Site

Providence, Rhode Island, United States

Site Status RECRUITING

Research Site

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Heidelberg, , Australia

Site Status RECRUITING

Research Site

Melbourne, , Australia

Site Status RECRUITING

Research Site

Nedlands, , Australia

Site Status RECRUITING

Research Site

Beijing, , China

Site Status RECRUITING

Research Site

Guangzhou, , China

Site Status RECRUITING

Research Site

Jinan, , China

Site Status WITHDRAWN

Research Site

Tianjin, , China

Site Status RECRUITING

Research Site

Zhengzhou, , China

Site Status RECRUITING

Research Site

Ostrava - Poruba, , Czechia

Site Status RECRUITING

Research Site

Prague, , Czechia

Site Status RECRUITING

Research Site

Praha 2 - Nové Město, , Czechia

Site Status RECRUITING

Research Site

Aalborg, , Denmark

Site Status RECRUITING

Research Site

Aarhus N, , Denmark

Site Status RECRUITING

Research Site

Copenhagen, , Denmark

Site Status RECRUITING

Research Site

Odense C, , Denmark

Site Status NOT_YET_RECRUITING

Research Site

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Research Site

Montpellier, , France

Site Status RECRUITING

Research Site

Paris, , France

Site Status RECRUITING

Research Site

Saint-Cloud, , France

Site Status RECRUITING

Research Site

Villejuif, , France

Site Status RECRUITING

Research Site

Cologne, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Kiel, , Germany

Site Status RECRUITING

Research Site

Mainz, , Germany

Site Status NOT_YET_RECRUITING

Research Site

München, , Germany

Site Status RECRUITING

Research Site

Würzburg, , Germany

Site Status RECRUITING

Research Site

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Milan, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Kōtoku, , Japan

Site Status RECRUITING

Research Site

Matsuyama, , Japan

Site Status RECRUITING

Research Site

Nagoya, , Japan

Site Status RECRUITING

Research Site

Busan, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Palma de Mallorca, , Spain

Site Status RECRUITING

Research Site

Santiago de Compostela, , Spain

Site Status RECRUITING

Research Site

Valencia, , Spain

Site Status RECRUITING

Research Site

Changhua, , Taiwan

Site Status RECRUITING

Research Site

Kaohsiung City, , Taiwan

Site Status RECRUITING

Research Site

Tainan, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Derriford, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

Oxford, , United Kingdom

Site Status RECRUITING

Research Site

Southampton, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Australia China Czechia Denmark France Germany Italy Japan South Korea Spain Taiwan United Kingdom

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

[email protected]
1-877-240-9479

Other Identifiers

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2024-515034-33-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

D7407C00001

Identifier Type: -

Identifier Source: org_study_id

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