Mosunetuzumab for CLL MRD Clearance

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Inhye Ahn
Study ID
NCT07052695
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Mosunetuzumab — DRUG
    Subcutaneous injection of a CD20xCD3 bispecific antibody
  • Ibrutinib — DRUG
    For participants who have been ibrutinib PO prior to enrollment
  • Acalabrutinib — DRUG
    For participants who have been acalabrutinib PO prior to enrollment
  • Zanubrutinib — DRUG
    For participants who have been zanubrutinib PO prior to enrollment
  • Pirtobrutinib — DRUG
    For participants who have been pirtobrutinib PO prior to enrollment

Study Details

The goal of this study is to test mosunetuzumab given alone or in combination with a Bruton tyrosine kinase inhibitor (BTKi, such as ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) in participants with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL). The names of the study drugs in this research study are: * Mosunetuzumab * BTK inhibitor: Ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib

Key Dates

Start date
Nov 24, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BCL2i arm
    20 enrolled participants who have been previously treated with a BCL2i-containing regimen will receive up to 17 cycles of mosunetuzumab
  • Experimental: BTKi arm
    20 enrolled participants who have been on a BTKi will receive up to 17 cycles of mosunetuzumab. Each participant will continue the BTKi during treatment with mosunetuzumab.

Primary Outcome Measure

Rate of undetectable bone marrow minimal residual disease [ Time Frame: Up to 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham & Women's HospitalBostonMassachusetts02215
Inhye Ahn, MD
877-DF-TRIAL
Dana-Farber Cancer InstituteBostonMassachusetts02215
Inhye Ahn, MD
877-DF-TRIAL

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