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New hope for Hard-to-Treat leukemia: Two-Drug combo enters human trials

NCT ID NCT05091424

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial is testing two drugs, mosunetuzumab and venetoclax, in people with chronic lymphocytic leukemia (CLL) that has come back or stopped responding to treatment. Mosunetuzumab is given as a shot under the skin, and venetoclax is a daily pill. The study will check for safety, side effects, and whether the drugs help shrink the cancer. About 137 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mosunetuzumab (Lunsumio) and venetoclax (Venclexta)
What this could lead to
If successful, this could offer a new treatment option for people with CLL that has stopped responding to other therapies.
What could go wrong
This is an early Phase 1 trial focused on safety, so it is too soon to know if the drugs will work. Side effects like cytokine release syndrome are possible.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 332 people

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

Started

Mar 2022

Expected to finish

Feb 2032

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: * Have a diagnosis of CLL requiring treatment according to the International Workshop on CLL (iwCLL) criteria (Hallek et al 2018) * Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2 * Adequate bone marrow (BM) function independent of growth factor or transfusion support, within 2 weeks of screening, at screening as defined by the protocol unless cytopenia is clearly due to marrow involvement of CLL * Adequate liver function unless directly attributable to the participant's CLL * Life expectancy \> 6 months * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year, and agreement to refrain from donating eggs during the treatment period and for at least 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable) * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm as defined by the protocol Inclusion Criteria Specific to Arm B: * Participants must have been taking a BTKi for at least 12 months, have demonstrated evidence of progressive disease while receiving the BTKi and require additional salvage therapy as assessed by their treating physician. Participants should be able to continue their previously prescribed BTKi at a stable dose throughout the study screening period and for up to three cycles of mosunetuzumab administration Inclusion Criteria Specific to Arm C: * Non-US participants only Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and tocilizumab or within 30 days after the final dose of venetoclax (if applicable) * Participants who have received any of the following treatments prior to study entry: treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies; allogenic stem cell transplant * Participants who have received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment: radiotherapy within 2 weeks prior to the first dose of study treatment; autologous stem cell transplant within 100 days prior to first study treatment; CAR T-cell therapy within 30 days before first study treatment; prior use of any monoclonal antibodies, radioimmunoconjugates, or antibody-drug conjugates for anti-CLL treatment within 4 weeks before first dose of study treatment; systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of study treatment; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy within 4 weeks prior to initiation of study treatment (except for participants enrolled in Arm B, where overlapping therapy is permitted; other prior cancer immunotherapy not explicitly defined by the protocol is to be discussed with the medical monitor to determine eligibility * Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment, or in whom it is anticipated that such a vaccine will be required during the study period or within 5 months after the final dose of study treatment * Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL) * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * Contraindication to tocilizumab * History of prior malignancy except for conditions defined by the protocol * Participants with infections requiring intravenous (IV) treatment with antibiotics or hospitalization within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment * Evidence of any significant concomitant disease that could affect compliance with the protocol or interpretation of results * Recent major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies) * Positive SARS-CoV-2 test within 7 days prior to enrollment Exclusion Criteria Specific to Arm C: * Have received venetoclax therapy within 12 months prior to first study treatment administration * Participants with known infection with HIV or human T-cell leukemia virus 1 (HTLV1) * HIV testing will be performed in countries where mandatory testing by health authorities is required * HTLV testing is required in participants from endemic countries * Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia * Participants who have received the following: strong and moderate CYP3A inhibitors within 7 days prior to the initiation of study treatment; strong and moderate CYP3A inducers within 7 days prior to the initiation of study treatment; steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration * Have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration * Inability to swallow a large number of tablets * Malabsorption syndrome or other condition that precludes enteral route of administration * Known allergy to both xanthine oxidase inhibitors and rasburicase

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma

As listed by the trial registrant

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

Chronic lymphocytic leukemia Chronic lymphocytic leukemia or small lymphocytic lymphoma

How to take part

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

  1. The places running it

    24 sites in 9 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

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    RECRUITING

    Brescia, Lombardy, 25123, Italy

  • Asst Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Lombardy, 20162, Italy

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    RECRUITING

    Sant'Andrea Delle Fratte (PG), Umbria, 06132, Italy

  • Christie Hospital NHS Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Chu de Clermont Ferrand

    WITHDRAWN

    Clermont-Ferrand, 63003, France

  • Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Huntsman Cancer Institute at The University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IUCT Oncopole

    WITHDRAWN

    Toulouse, 31059, France

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • Memorial Sloan-Kettering Cancer Center

    WITHDRAWN

    New York, New York, 10065, United States

  • Monash Medical Centre

    RECRUITING

    Melbourne, Victoria, 3168, Australia

  • Osp. San Raffaele

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • PRATIA MCM Kraków

    RECRUITING

    Krakow, 30-727, Poland

  • Peking University People's Hospital

    RECRUITING

    Beijing, 100044, China

  • Peter MacCallum Cancer Center

    COMPLETED

    East Melbourne, Victoria, 3002, Australia

  • Princess Alexandra Hospital Woolloongabba

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Seoul St Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • Southern Medical University Nanfang Hospital

    RECRUITING

    Guangzhou, 510515, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • The James Cancer Hospital and Solove Research Institute

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Tianjin Institute of Hematology & Blood Diseases Hospital

    RECRUITING

    Tianjin, 301600, China

  • Uni of Texas - Md Anderson Cancer Center

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Uniklinik Koln

    WITHDRAWN

    Cologne, 50937, Germany

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • Universitätsklinikum Ulm

    WITHDRAWN

    Ulm, 89081, Germany

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    RECRUITING

    Wroc?aw, 50-367, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gda?sk, 80-214, Poland

  • Yeouido St. Mary's Hospital

    RECRUITING

    Seoul, 07345, South Korea

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