Mosunetuzumab for Chronic Lymphocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of mosunetuzumab for individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Researchers are testing it alone or with a Bruton tyrosine kinase inhibitor (BTKi), such as ibrutinib or acalabrutinib. Suitable candidates include those who have been on continuous BTKi treatment for over a year or have recently completed BCL2i therapy. As a Phase 1 and Phase 2 trial, the research focuses on understanding the treatment's effects and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you should not be on certain immunosuppressive drugs or high doses of prednisone shortly before starting the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mosunetuzumab is generally well-tolerated by patients. One study found no new safety concerns or delayed side effects, which reassures those considering this treatment. Some patients experienced side effects like cytokine release syndrome (CRS), causing fever and tiredness, but these were usually mild.
Bruton tyrosine kinase inhibitors (BTK inhibitors) such as ibrutinib, acalabrutinib, zanubrutinib, and pirtobrutinib have been used in other treatments and are known to cause some common side effects. These can include headaches, diarrhea, and muscle pain, but they are often manageable.
Overall, both mosunetuzumab and BTK inhibitors have safety profiles suggesting they are tolerable for most patients. However, discussing any concerns with a healthcare professional before joining a trial is important.12345Why are researchers excited about this trial's treatments?
Mosunetuzumab is unique because it works differently from the usual treatments for chronic lymphocytic leukemia (CLL), which often include BTK inhibitors like Acalabrutinib or Ibrutinib. Unlike these, Mosunetuzumab is a bispecific antibody that targets both CD20 on B-cells and CD3 on T-cells, effectively bringing the immune system directly to the cancer cells to destroy them. This innovative approach harnesses the body's own immune system to fight CLL, offering a potentially more direct and effective attack on cancer cells. Researchers are excited about Mosunetuzumab because it could provide an option for patients who have not responded well to other treatments, especially those who have tried BTK inhibitors or BCL2 inhibitors without success.
What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?
Research shows that mosunetuzumab has promising results for treating some blood cancers. Previous studies found that many patients respond well to mosunetuzumab, experiencing long-lasting improvements. These studies also indicate that the treatment is generally safe and manageable for patients. In this trial, participants in the BTKi arm will receive mosunetuzumab alongside Bruton tyrosine kinase inhibitors like ibrutinib and acalabrutinib. These inhibitors have been effective in treating chronic lymphocytic leukemia (CLL) by blocking signals that promote cancer cell growth. This combination might offer a strong approach to treating CLL.12567
Who Is on the Research Team?
Inhye Ahn, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have a particular stage of disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mosunetuzumab alone or in combination with a BTKi for up to 17 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes such as progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Acalabrutinib
- Ibrutinib
- Mosunetuzumab
- Pirtobrutinib
- Zanubrutinib
Trial Overview
The study is testing the effectiveness of mosunetuzumab alone or combined with a Bruton tyrosine kinase inhibitor (BTKi), which could be ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib. The goal is to see if these treatments can clear CLL MRD (minimal residual disease).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
20 enrolled participants who have been on a BTKi will receive up to 17 cycles of mosunetuzumab. Each participant will continue the BTKi during treatment with mosunetuzumab.
20 enrolled participants who have been previously treated with a BCL2i-containing regimen will receive up to 17 cycles of mosunetuzumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inhye Ahn
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Citations
NCT05091424 | A Study Evaluating the Safety, Efficacy, ...
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with ...
2.
genentech-clinicaltrials.com
genentech-clinicaltrials.com/en/trials/cancer/leukemia/a-study-evaluating-the-safety--efficacy--and-pharmacoki-80734.htmlClinical Trial – Chronic Lymphocytic Leukemia – Efficacy,...
A clinical trial to compare how safe and effective different doses of mosunetuzumab on its own or in combination with other treatments are in people with
Real-World Effectiveness of Frontline Treatments Among ...
Regarding TTNT-D, at 2 years' follow-up, 69.1%, 82.5%, 86.3%, 79.1%, and 53.0% of patients treated with first- and second-generation cBTKis, ...
4.
bloodcancerstoday.com
bloodcancerstoday.com/post/clinically-meaningful-and-durable-response-of-mosunetuzumab-in-mzlClinically Meaningful and Durable Response of ...
Frontline mosunetuzumab achieved high response rates and sustained remissions in untreated MZL, with manageable CRS and safety in Phase II ...
Interim results from the phase II MorningSun study.
Mosun SC achieved high response rates with manageable safety in patients with 3L+ FL in a pivotal Phase II study (Bartlett et al. ASH 2024). We ...
6.
forpatients.roche.com
forpatients.roche.com/content/patient-platform/global/en/trials/cancer/leukemia/a-safety-and-pharmacokinetic-study-of-btct4465a--mosunetuzumab--.pdfA clinical trial to look at how safe different doses ... - ForPatients
Participants will be told about the known side effects of mosunetuzumab, atezolizumab, and tocilizumab, and possible side effects based on human and laboratory ...
Durable Responses With Mosunetuzumab in Relapsed ...
Patients who achieved CR had durable responses. Importantly, no new safety concerns nor delayed toxicities were identified.
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