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New drug combo trial targets blood cancers

NCT ID NCT06564038

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This study tests a new drug called AZD0486, alone or with other cancer drugs, in people with B-cell blood cancers like certain lymphomas and leukemias. The goal is to see if it is safe and helps shrink or control the cancer. About 408 adults will take part in this early-phase trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 408 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. * 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: 1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022. 2. R/R B-NHL after at least 1 prior lines of systemic therapy. 3. International Prognostic Index (IPI) 2-5. * Cohort 3B: 1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022. 2. IPI score of 2 to 5. Exclusion Criteria: 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    63 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Research Site

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Research Site

    RECRUITING

    New York, New York, 10029, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10065, United States

  • Research Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Research Site

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Research Site

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Research Site

    RECRUITING

    Portland, Oregon, 97239, United States

  • Research Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Research Site

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Research Site

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Heidelberg, 3084, Australia

  • Research Site

    RECRUITING

    Melbourne, 3004, Australia

  • Research Site

    RECRUITING

    Nedlands, 6009, Australia

  • Research Site

    RECRUITING

    Beijing, 100044, China

  • Research Site

    RECRUITING

    Guangzhou, 510060, China

  • Research Site

    WITHDRAWN

    Jinan, 250013, China

  • Research Site

    RECRUITING

    Tianjin, 300060, China

  • Research Site

    RECRUITING

    Zhengzhou, 450008, China

  • Research Site

    RECRUITING

    Ostrava - Poruba, 708 52, Czechia

  • Research Site

    RECRUITING

    Prague, 12808, Czechia

  • Research Site

    RECRUITING

    Praha 2 - Nové Město, 12820, Czechia

  • Research Site

    RECRUITING

    Aalborg, 9000, Denmark

  • Research Site

    RECRUITING

    Aarhus N, 8200, Denmark

  • Research Site

    RECRUITING

    Copenhagen, 2100, Denmark

  • Research Site

    RECRUITING

    Odense C, 5000, Denmark

  • Research Site

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63000, France

  • Research Site

    RECRUITING

    Montpellier, 34295, France

  • Research Site

    RECRUITING

    Paris, 75010, France

  • Research Site

    RECRUITING

    Saint-Cloud, 92210, France

  • Research Site

    RECRUITING

    Villejuif, 94805, France

  • Research Site

    NOT_YET_RECRUITING

    Cologne, 50937, Germany

  • Research Site

    NOT_YET_RECRUITING

    Homburg, 66421, Germany

  • Research Site

    RECRUITING

    Kiel, 24105, Germany

  • Research Site

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

  • Research Site

    RECRUITING

    München, 81377, Germany

  • Research Site

    RECRUITING

    Würzburg, 97080, Germany

  • Research Site

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Matsuyama, 791-0280, Japan

  • Research Site

    RECRUITING

    Nagoya, 464-8681, Japan

  • Research Site

    RECRUITING

    Busan, 48108, South Korea

  • Research Site

    RECRUITING

    Seoul, 02841, South Korea

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    RECRUITING

    Barcelona, 8036, Spain

  • Research Site

    RECRUITING

    Madrid, 28034, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Palma de Mallorca, 7120, Spain

  • Research Site

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Research Site

    RECRUITING

    Valencia, 46026, Spain

  • Research Site

    RECRUITING

    Changhua, 500, Taiwan

  • Research Site

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Research Site

    RECRUITING

    Tainan, 710, Taiwan

  • Research Site

    RECRUITING

    Taipei, 100, Taiwan

  • Research Site

    RECRUITING

    Derriford, PL6 5FP, United Kingdom

  • Research Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Research Site

    RECRUITING

    Oxford, 0X3 7LJ, United Kingdom

  • Research Site

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.