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

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

Start date

Oct 1, 2026

Status verified

May 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 Mosunetuzuma Inpatient
  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.
• Experimental: Phase 2 : Treatment with Mosunetuzuma Outpatient
  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.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

• Mahesh Swaminathan, MBBS
  (832) 728-8778
  [email protected]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.
  PHASE1 · Recruiting · Dana-Farber Cancer Institute · Boston, Massachusetts