30 Participants NeededMy employer runs this trial

Mosunetuzumab for Lymphocytic Leukemia

MS
MS
Overseen ByMahesh Swaminathan, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: BTK inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mosunetuzumab, a type of immunotherapy, for individuals with chronic lymphocytic leukemia (CLL) who still show signs of the disease after using specific leukemia medications for at least six months. The trial aims to evaluate mosunetuzumab's effectiveness in targeting and fighting cancer cells. Participants should have tried at least two different treatment plans for CLL and continue to experience symptoms or detectable disease despite long-term therapy. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, certain treatments like systemic immunosuppressive medications and some cancer therapies must be stopped before starting the study treatment. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that mosunetuzumab is likely to be safe for humans?

Research has shown that mosunetuzumab is generally well-tolerated, meaning most people can manage its side effects. In earlier studies, about 45% of patients experienced serious side effects, but these studies included individuals with various conditions. The most common side effects were low blood cell counts and fever, often manageable with medical care.

Overall, mosunetuzumab showed promise in earlier research, and ongoing studies aim to confirm its safety for individuals with conditions like chronic lymphocytic leukemia. Prospective participants should discuss potential side effects with a healthcare provider before joining a trial.12345

Why do researchers think this study treatment might be promising for leukemia?

Mosunetuzumab is unique because it targets CD20 and CD3 proteins, offering a novel approach to treating lymphocytic leukemia. Unlike traditional therapies like chemotherapy and targeted drugs such as BTK inhibitors, Mosunetuzumab is a bispecific antibody that brings T-cells directly to the cancer cells, potentially enhancing the immune system's ability to attack the cancer. Researchers are excited about Mosunetuzumab because it may offer a more targeted attack with potentially fewer side effects compared to conventional treatments.

What evidence suggests that mosunetuzumab might be an effective treatment for chronic lymphocytic leukemia?

Research has shown that mosunetuzumab, a special type of antibody, may help treat chronic lymphocytic leukemia (CLL). In one study, 40% of patients responded to the treatment, and 20% had a complete response, with some responses lasting over 20 months. Another study found that patients lived longer without their disease worsening, with a median time of 24 months. These findings suggest that mosunetuzumab can be effective for CLL patients, especially those who have previously used Bruton's tyrosine kinase inhibitors. The data highlight mosunetuzumab's potential to provide lasting benefits. Participants in this trial will receive mosunetuzumab in either an inpatient or outpatient setting, depending on the treatment phase.12456

Who Is on the Research Team?

MS

Mahesh Swaminathan, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults (18+) with chronic lymphocytic leukemia who still have detectable disease after at least 6 months on BTK inhibitor treatment, are otherwise stable, and have had at least two prior treatments. Participants must have good organ function and not be pregnant or breastfeeding.

Inclusion Criteria

My bone marrow, liver, and kidneys are working well.
Life expectancy >6 months
Ability to comply with the study protocol and procedures
See 8 more

Exclusion Criteria

I have had certain treatments or procedures recently.
My cancer is considered to have a high disease burden.
History of specific viral infections or autoimmune diseases
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-In Treatment

Initial treatment with mosunetuzumab on an inpatient basis during step up dosing (Cycle 1) for the first 6 participants

1 cycle
Inpatient visits for Cycle 1

Treatment

Treatment with mosunetuzumab in an outpatient setting for all cycles following the lead-in phase

17 cycles

Follow-up

Participants are monitored for MRD status every 6 months after end of combined treatment for 3 years

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Mosunetuzumab

Trial Overview

The study tests mosunetuzumab, a new antibody therapy that targets cancer cells in CLL patients who haven't progressed but still show signs of the disease after previous treatments. All participants receive this drug to see how well it works.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Phase 2: Treatment with Mosunetuzuma OutpatientExperimental Treatment1 Intervention
Group II: Phase 2 Lead-In Phase: Treatment with Mosunetuzumab InpatientExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

Mosunetuzumab monotherapy is active and tolerable in ...

Mosunetuzumab resulted in an overall response rate of 40% and a complete response (CR) rate of 20%. CRs were durable, with 2 patients experiencing CR for >20 ...

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 ...

Clinical Trial – Chronic Lymphocytic Leukemia – Efficacy,...

This clinical trial aims to test mosunetuzumab at different doses on its own or in combination with BTKi. This is to understand how safe and how well it works ...

Mosunetuzumab in R/R Richter's transformation: Phase I/II ...

The best ORR was 40%, with a CR in 20% of patients. The median PFS was 3.2 months, and the median OS was 10.2 months. Key learning: ...

Mosunetuzumab monotherapy is active and tolerable in ...

Real World Data on the Outcomes of Richter's. Transformation of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma in the. Australian Population: An ...

AN ONGOING PHASE 1B TRIAL EVALUATING ...

Mosunetuzumab monotherapy may have promise in R/R CLL and could exert synergistic activity when combined with the complementary mechanisms of ...