Trials / Recruiting
RecruitingNCT07052695
Mosunetuzumab for CLL MRD Clearance
A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Inhye Ahn · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
This is open-label, multicenter, pilot study of mosunetuzumab given alone or in combination with a BTKi in participants with CLL/SLL. Participants who are already taking a BTKi will continue the BTKi while receiving Mosunetuzumab on this study. Participants who have been previously treated with a drug called B-cell lymphoma 2 inhibitor (BCL2i) will receive Mosunetuzumab alone. Treatment with mosunetuzumab is given up to 17 cycles (approximately 1 year). Patients who achieve early MRD clearance will stop mosutuzumab after 8 cycles (approximately 6 months).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mosunetuzumab | Subcutaneous injection of a CD20xCD3 bispecific antibody |
| DRUG | Ibrutinib | For participants who have been ibrutinib PO prior to enrollment |
| DRUG | Acalabrutinib | For participants who have been acalabrutinib PO prior to enrollment |
| DRUG | Zanubrutinib | For participants who have been zanubrutinib PO prior to enrollment |
| DRUG | Pirtobrutinib | For participants who have been pirtobrutinib PO prior to enrollment |
Timeline
- Start date
- 2025-11-24
- Primary completion
- 2028-12-31
- Completion
- 2032-12-31
- First posted
- 2025-07-06
- Last updated
- 2025-12-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07052695. Inclusion in this directory is not an endorsement.