Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD

Part of paid clinical trials in Houston, Texas.

Sponsor: M.D. Anderson Cancer Center
Study ID: NCT07566364
Phase: PHASE2
Status: Recruiting

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Conditions

Lymphocytic Leukemia

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Mosunetuzumab — DRUG
Given by injection

Study Details

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.

Key Dates

First listed: May 5, 2026
Start date: Jul 9, 2026
Status verified: Jul 2026
Primary completion: Oct 31, 2028
Completion: Oct 31, 2030

Study Design

Enrollment: 30 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Phase 2 Lead-In Phase: Treatment with Mosunetuzumab Inpatient
Treatment will be administered inpatient during dose step up dosing during Cycle 1 (days 1, 8, 15) and then on cycles 2 and above mosunetuzma will be administered on day 1. all cycles will be 21 days long.
Experimental: Phase 2: Treatment with Mosunetuzuma Outpatient
Mosunetuzumab will be administered outpatient for all doses. During cycle 1, dose step up dosing will be administered on days 1, 8 and 15. Cycles 2 and beyond, mosunetuzumab will be administered on day 1. All cycles will be 21 days long.