Mosunetuzumab for Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Lorenzo Falchi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Immunosuppressants, Antiepileptics, others

Disqualifiers: CNS disease, Cardiovascular disease, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing mosunetuzumab, a drug that helps the immune system fight cancer, in people newly diagnosed with follicular lymphoma.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on strong CYP3A inhibitors or inducers, you may need to stop them for Cohort 2. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug Mosunetuzumab for treating follicular lymphoma?

Mosunetuzumab has shown promising results in treating relapsed or refractory follicular lymphoma, with an overall response rate of 80% and a complete response rate of 60% in a clinical trial. This suggests that the drug can be an effective option for patients who have not responded to other treatments.

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Is Mosunetuzumab safe for humans?

Mosunetuzumab has been well tolerated in clinical trials for patients with relapsed or refractory B-cell lymphoma, showing it is generally safe for human use.

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What makes the drug Mosunetuzumab unique for treating follicular lymphoma?

Mosunetuzumab is unique because it is a bispecific antibody that targets both CD20 and CD3, redirecting T cells to attack and eliminate cancerous B cells. This 'off-the-shelf' treatment offers a new option for patients with relapsed or refractory follicular lymphoma, showing high effectiveness with manageable side effects.

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Eligibility Criteria

Adults with newly diagnosed, untreated Follicular Lymphoma (FL) grades 1, 2, or 3A are eligible for this trial. They must have measurable disease and be fit for chemoimmunotherapy. Key requirements include good liver and bone marrow function, no severe heart or lung conditions, no active infections or other cancers within the last two years. Participants need to agree to biopsies and use effective contraception if of childbearing potential.

Inclusion Criteria

Agreement to contraceptive methods for men

I am 18 years old or older.

My liver is working well.

Exclusion Criteria

I have had a solid organ transplant.

Serologic test results indicating HIV infection

Pregnancy, lactation, or intention to become pregnant

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mosunetuzumab alone or with zanubrutinib for the treatment of newly diagnosed follicular lymphoma

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Participant Groups

The study is testing Mosunetuzumab's effectiveness in treating Follicular Lymphoma that hasn't been treated before. It aims to determine whether this drug can help patients with FL by assessing its impact on their cancer.

Group I: Single Agent Mosunetuzumab Experimental Treatment 1 Intervention

Participants with newly diagnosed FL in need of systemic therapy

Group II: Mosunetuzumab + Zanubrutinib Experimental Treatment 2 Interventions

Participants with newly diagnosed FL in need of systemic therapy

Mosunetuzumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lunsumio for:

• Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

🇺🇸 Approved in United States as Lunsumio for:

• Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Georgetown University (Data Collection Only) Washington, United States

Memorial Sloan Kettering Cancer Center New York, NY

Memorial Sloan Kettering Monmouth (Limited protocol activities) Middletown, NJ

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities Basking Ridge, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Mosunetuzumab and the emerging role of T-cell-engaging therapy in follicular lymphoma. [2023] Follicular lymphoma (FL) is the most common indolent lymphoma. Since the advent of rituximab, FL has seen a progressive improvement in patient prognosis. While chemotherapy combined with an anti-CD20 monoclonal antibody remains standard first-line therapy, most patients will relapse and require subsequent therapy. T-cell-redirecting therapies can be very potent and are transforming the therapeutic landscape in the relapsed and refractory (R/R) setting. T-cell-dependent bispecific antibodies, of which mosunetuzumab is the first to be approved for R/R FL, are proving to be a highly effective, 'off-the-shelf' option with manageable toxicities. This review covers approved treatments for R/R FL and focuses on preclinical and clinical data available for mosunetuzumab (Lunsumio™), with the goal of determining its role in the treatment of R/R FL.

2. England pubmed.ncbi.nlm.nih.gov

Mosunetuzumab and lymphoma: latest updates from 2022 ASH annual meeting. [2023] Bispecific antibodies are emerging as a promising new immunotherapy modality and are actively being evaluated in clinical trials for patients with lymphoma. As the first BsAb to receive regulatory approval for lymphoma, mosunetuzumab, an antiCD20/anti-CD3 BsAb, is an exciting new option for patients with relapsed or refractory (R/R) follicular lymphoma. The approval was based on results from an international, multicenter, phase 2 trial in patients with relapsed or refractory (R/R) follicular lymphoma following at least 2 prior lines of systemic therapy. Mosunetuzumab demonstrated remarkable efficacy with an overall response rate of 80% and complete response rate of 60%. Here we provided an overview of the latest clinical data on mosunetuzumab in lymphoma presented at the 2022 ASH Annual Meeting.

3. United States pubmed.ncbi.nlm.nih.gov

Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. [2023] Mosunetuzumab is a bispecific antibody targeting CD20 and CD3 that redirects T cells to engage and eliminate malignant B cells and is being developed for relapsed or refractory (R/R) B-cell non-Hodgkin lymphomas (B-NHLs).

4. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness between mosunetuzumab monotherapy clinical trial and real-world data in relapsed/refractory follicular lymphoma in third or subsequent lines of systemic therapy. [2023] A comparison of clinical outcomes in the third or subsequent line (3 L+) of systemic therapy between a real-world data (RWD) external control cohort and a mosunetuzumab single-arm clinical trial cohort is presented. Data for 3 L + patients with relapsed/refractory follicular lymphoma (FL) were obtained from the mosunetuzumab single-arm trial (n = 90) and a US electronic health records database (n = 158), with patients meeting key eligibility criteria from the trial, balanced on pre-specified prognostic factors. Overall response and complete response rates were 80% and 60% in the mosunetuzumab cohort and 75% and 33% in the RWD cohort, odds ratios of 1.23 (95% CI, 0.52-2.93) and 3.18 (95% CI, 1.41-7.17), respectively. Hazard ratios for progression-free survival and overall survival were 0.82 (95% CI, 0.53-1.27) and 0.43 (95% CI, 0.19-0.94). These findings support a clinically meaningful benefit of mosunetuzumab monotherapy as a chemotherapy-free option for the 3 L + FL population.

5. New Zealand pubmed.ncbi.nlm.nih.gov

Mosunetuzumab: First Approval. [2022] Mosunetuzumab (Lunsumio®), an anti-CD20/CD3 T-cell engaging bispecific antibody, is being developed by Roche for the treatment of relapsed or refractory follicular lymphoma. Mosunetuzumab was recently conditionally approved in the EU for the treatment of relapsed or refractory follicular lymphoma in adults who have received at least two prior systemic therapies. This article summarizes the milestones in the development of mosunetuzumab leading to this first approval for relapsed or refractory follicular lymphoma.

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. [2022] Mosunetuzumab is a CD20 × CD3 T-cell-engaging bispecific monoclonal antibody that redirects T cells to eliminate malignant B cells. In a phase 1 study, mosunetuzumab was well tolerated and active in patients with relapsed or refractory B-cell lymphoma. We, therefore, aimed to evaluate the safety and anti-tumour activity of fixed-duration mosunetuzumab in patients with relapsed or refractory follicular lymphoma who had received two or more previous therapies.