Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-02 @ 7:57 AM
Study NCT ID:
NCT07052695
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mosunetuzumab for CLL MRD Clearance
Sponsor:
Inhye Ahn
Organization:
Study Overview
Official Title:
A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: