What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include targeted therapies like BTK inhibitors (e.g., ibrutinib, acalabrutinib), BCL2 inhibitors (e.g., venetoclax), and monoclonal antibodies (e.g., rituximab, obinutuzumab). These treatments can cause a range of side effects. BTK inhibitors are associated with hematologic adverse effects, atrial fibrillation, hypertension, and infections. BCL2 inhibitors can lead to tumor lysis syndrome, neutropenia, and gastrointestinal issues. Monoclonal antibodies often cause infusion reactions, especially during the first cycle. Bispecific antibodies like Mosunetuzumab, which target CD20 on B-cells and CD3 on T-cells, can cause cytokine release syndrome, neurotoxicity, and infections. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Lymphocytic Leukemia (CLL) include targeted therapies such as Bruton tyrosine kinase (BTK) inhibitors (ibrutinib, acalabrutinib, zanubrutinib) and BCL-2 inhibitors (venetoclax). While Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, is still under investigation, other anti-CD20 monoclonal antibodies like rituximab, obinutuzumab, and ofatumumab have been approved for CLL. These treatments focus on targeting specific proteins on B-cells to enhance the immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to Mosunetuzumab for CLL patients include: 1) Acalabrutinib, a BTK inhibitor with a favorable tolerability profile. 2) Zanubrutinib, another BTK inhibitor known for its efficacy and tolerability. 3) Venetoclax in combination with Obinutuzumab, which has shown high rates of undetectable minimal residual disease (MRD). These therapies offer targeted treatment options with varying mechanisms of action and have demonstrated significant efficacy in clinical trials.

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Checkpoint Inhibitor

Atezolizumab + BTCT4465A (Mosunetuzumab) for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival

Must not have

Systemic immunosuppressive medication within 2 weeks prior to study drug

Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called Mosunetuzumab, both alone and with another drug called atezolizumab, in patients with blood cancers that have not responded to other treatments. These drugs work by helping the immune system find and destroy cancer cells. Atezolizumab is a medication that has been approved for use in various cancers, including breast cancer, and has shown effectiveness when combined with other treatments.

Who is the study for?

This trial is for adults with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia who have tried at least one treatment that didn't work. They should be in fairly good health otherwise, not pregnant, and haven't had certain treatments like stem cell transplants recently.

What is being tested?

Researchers are testing Mosunetuzumab, given by injection or IV, alone and combined with Atezolizumab to see how safe and effective they are against these blood cancers. The study has two parts: finding the right dose and then seeing how well it works in specific groups.

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, tiredness, changes in blood tests (like liver function), increased risk of infections due to a weakened immune system, and possibly others as this is an early-phase trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My B-cell cancer has not improved after at least one treatment and no other treatments are likely to help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any immunosuppressive drugs in the last 2 weeks.

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I have had a stem cell transplant using my own cells within the last 100 days or any transplant from a donor.

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I haven't had radiotherapy in the last 2 weeks before starting Mosunetuzumab.

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I haven't had CAR-T therapy in the last 30 days.

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I have had a brain lymphoma or other brain condition.

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I have a serious heart or lung condition.

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I have Hepatitis B, C, or HIV.

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I have not received a live vaccine in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Scores to Assess Health-Related Quality of Life (HRQoL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.

Group II: Dose EscalationExperimental Treatment3 Interventions

Participants will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with atezolizumab. Dose escalation will be guided by the observed incidence of DLTs at each dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Lymphocytic Leukemia (CLL) include bispecific antibodies, monoclonal antibodies, and targeted agents. Bispecific antibodies, such as Mosunetuzumab, target CD20 on B-cells and CD3 on T-cells, facilitating the immune system's ability to recognize and destroy malignant B-cells. Monoclonal antibodies like obinutuzumab and rituximab also target CD20, leading to direct cytotoxicity and immune-mediated cell death. Targeted agents, including BTK inhibitors (e.g., ibrutinib) and BCL2 inhibitors (e.g., venetoclax), disrupt critical survival pathways in CLL cells, leading to apoptosis. These treatments are crucial for CLL patients as they offer more precise and effective options, often with fewer side effects compared to traditional chemotherapy, and can lead to deeper and more durable remissions.

Immunotherapeutic Strategies in Chronic Lymphocytic Leukemia: Advances and Challenges.The latest developments with anti-CD20 monoclonal antibodies in chronic lymphocytic leukemia.Cytotoxic effects of the trifunctional bispecific antibody FBTA05 in ex-vivo cells of chronic lymphocytic leukaemia depend on immune-mediated mechanism.