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A clinical trial to compare how safe and effective different doses of mosunetuzumab are in people with chronic lymphocytic leukaemia that has not responded to, or has come back after previous treatments
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia
- Chronic Lymphocytic Leukemia
Trial Status:
Recruiting
This trial runs in
Countries
- Australia
- France
- Germany
- Italy
- Spain
- United Kingdom
- United States
Trial Identifier:
NCT05091424 BO43243
Trial Summary
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT05091424 , BO43243
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
1. Why is the BO43243 clinical trial needed?
Chronic lymphocytic leukaemia (CLL) is a type of blood cancer in which the bone marrow makes too many B-cells (a type of white blood cell). The excess B-cells build up and stop the blood, bone marrow and lymph nodes working properly. Standard treatment for CLL includes medicines such as:
- Bruton’s tyrosine kinase inhibitors (BTKi) such as ibrutinib and acalabrutinib, which work by blocking a protein called BTK on CLL cells so they cannot grow as quickly
- Venetoclax, which works by blocking the action of a protein called BCL2 that helps keep CLL cells alive. Venetoclax can be given on its own or with:
- Rituximab or obinutuzumab, which are known as ‘immunotherapies’ because they stick to CLL cells and help the body’s immune system fight the cancer, and /or
- Chemotherapy
Treatment can include stem cell transplant but for most people age or medical conditions prevent this. Some people have CLL that does not respond to or comes back after treatment with standard medicines. More treatments are needed for people with CLL when previous treatment has not worked. Mosunetuzumab is a type of immunotherapy. Mosunetuzumab attaches to a marker called CD20 that is on some types of CLL cells. This brings them closer to cancer-killing immune cells. Mosunetuzumab is an experimental drug – this means health authorities have not approved mosunetuzumab for treating CLL, but mosunetuzumab has been approved to treat a cancer called follicular lymphoma.
This clinical trial aims to test the safety of mosunetuzumab at different doses and to understand how the body processes mosunetuzumab.
2. How does the BO43243 clinical trial work?
This clinical trial is recruiting people with a health condition called chronic lymphocytic leukaemia (CLL). People can take part if their CLL has not responded to previous treatment (known as ‘refractory’ CLL) or has come back after treatment (known as ‘relapsed’ CLL).
People who take part in this clinical trial (participants) will be given increasing doses of the clinical trial treatment mosunetuzumab every week until the target dose is reached, unless their cancer gets worse or they have unacceptable side effects. Participants will stay in the hospital for 2 days after each dose and will be given a medicine called a corticosteroid to lower the chance of side effects. Once the target dose is reached, mosunetuzumab will be given (without needing to stay in hospital after each dose) once every 3 weeks for about 1 year, unless a participants’ cancer gets worse or they have unacceptable side effects. The clinical trial doctor will see them at least every 3 weeks. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. Participants will also be seen 1 month after the last dose of mosunetuzumab is given. Then they will be followed up for as long as they agree to it, about every 3 months for 2 years, then every 6 months. Total time in the clinical trial will depend on how participants’ cancer responds to treatment, and if they have unacceptable side effects. Participants can stop trial treatment and leave the clinical trial at any time.
3. What are the main endpoints of the BO43243 clinical trial?
The main clinical trial endpoint (the main result measured in the trial to see if the drug has worked) is the number and seriousness of side effects with different doses of mosunetuzumab.
The other clinical trial endpoints include:
- How many participants have a response to treatment (objective response rate)
- How many participants have no CLL cells detectable in their blood or bone marrow 2–3 months after the final dose of treatment
- The length of time between the start of the trial and participant’s cancer getting worse (progression-free survival)
- How long participants live (overall survival)
- The time between treatment and having a change in disease or treatment (event-free survival)
- How many participants have no signs of cancer on scans or tests (complete response)
- How much time there is between participant’s cancer getting better from treatment and then getting worse (duration of response)
- How the body processes mosunetuzumab
4. Who can take part in this clinical trial?
People can take part in this trial if they are over the age of 18 and have CLL that has not responded to, or has come back after at least two treatments. People may not be able to take part in this trial if they have certain medical conditions including severe heart, lung or liver disease. People also may not be able to take part if they have had certain treatments including mosunetuzumab. Women cannot take part in this trial if they are pregnant or breastfeeding or are planning to become pregnant during or soon after the clinical trial.
5. What treatment will participants be given in this clinical trial?
Everyone who joins this clinical trial will be given increasing doses of mosunetuzumab. This will be given as an injection under the skin (subcutaneous injection). The dose will increase weekly until the target dose is reached. The target dose will be given every 3 weeks for about 1 year, unless a participants’ cancer gets worse or they have unacceptable side effects. This is an open-label trial, which means everyone involved, including the participant and the clinical trial doctor, will know the participant has been given mosunetuzumab. If a participant experiences a potential side effect called ‘cytokine release syndrome’ (when the body’s immune cells are activated and release large amounts of inflammatory substances throughout the body), they may receive another medicine called tocilizumab.
6. Are there any risks or benefits in taking part in this clinical trial?
The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant. However, it may not be greater than the risks related to routine medical care or the natural progression of the health condition. People who would like to participate will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial).
Risks associated with the clinical trial drugs
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe, even life-threatening, and may vary from person to person. Participants will be closely monitored during the clinical trial; safety assessments will be performed regularly. Participants will be told about the known side effects of mosunetuzumab and tocilizumab and possible side effects based on human and laboratory studies or knowledge of similar drugs. Mosunetuzumab will be given by injection under the skin (subcutaneous injection). Participants will be told about any known side effects of subcutaneous injection. Tocilizumab will be given by infusion into a vein (intravenous infusion). Participants will be told about any known side effects of intravenous infusion.
Potential benefits associated with the clinical trial
Participants' health may or may not improve from participation in the clinical trial. Still, the information collected may help other people with similar medical conditions in the future.
For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT05091424
Trial Summary
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT05091424 , BO43243
Trial Identifier
Mosunetuzumab, Tocilizumab
Treatments
Chronic Lymphocytic Leukemia
Condition
Official Title
A Phase IB Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
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 (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; use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first 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 or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment; 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)
For the latest version of this information please go to www.forpatients.roche.com