Mosunetuzumab for Lymphocytic Leukemia

Overseen By Mahesh Swaminathan, MBBS

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: BTK inhibitors

Must not be taking: Immunosuppressants, Monoclonal antibodies

Disqualifiers: High disease burden, Pregnancy, Infections, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 17 cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the therapeutic efficacy of mosunetuzumab, a bispecific antibody targeting CD20 and CD3 in patients who have detectable chronic lymphocytic leukemia (CLL) after receiving Bruton's tyrosine kinase inhibitors (BTKis) for at least 6 months and have no clinical or laboratory evidence of disease progression.

Who Is on the Research Team?

Mahesh Swaminathan, MBBS

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

Inclusion Criteria

My bone marrow, liver, and kidneys are working well.

Life expectancy >6 months

Ability to comply with the study protocol and procedures

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

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

How Is the Trial Designed?

Group I: Phase 2 Lead-In Phase: Treatment with Mosunetuzuma Inpatient Experimental Treatment 1 Intervention

Treatment will be administered on an inpatient basis during step up dosing (Cycle 1) for the first 6 participants (lead-in-phase). The rest of the patients will be treated in the outpatient setting for all cycles.

Group II: Phase 2 : Treatment with Mosunetuzuma Outpatient Experimental Treatment 1 Intervention

Treatment will be administered on an inpatient basis during step up dosing (Cycle 1) for the first 6 patients (lead-in-phase). The rest of the participants will be treated in the outpatient setting for all cycles.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+