NCT07014319

Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies

Maribavir Treatment of Cytomegalovirus for Lymphoid Malignancy Patients Undergoing Bispecific Antibodies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm, multicenter study to evaluate the feasibility of maribavir treatment in multiple myeloma and lymphoma patients undergoing bispecific antibody treatment and experiencing treatment emergent CMV events

Detailed description

This open-label, single-arm, multicenter study aims to evaluate the safety and feasibility of maribavir in patients with multiple myeloma or lymphoma who develop cytomegalovirus (CMV) reactivation during bispecific antibody (BsAb) therapy. While BsAbs are increasingly used in lymphoma and multiple myeloma due to their high efficacy, they are associated with a high risk of infections, particularly CMV, especially in heavily pretreated and immunocompromised patients. Existing anti-CMV treatments are often limited by toxicity and accessibility. Maribavir, an oral antiviral with a novel mechanism and favorable safety profile, offers a promising alternative. Given the high CMV burden observed in this population, this study seeks to address an important unmet need.

Conditions

• Cytomegalovirus (CMV)

Interventions

Type	Name	Description
DRUG	Maribavir	Participants will receive maribavir 400 mg twice daily starting from Week 1 and continuing until clearance of CMV. CMV clearance is defined as either an unquantifiable plasma CMV DNA titer (i.e., below the lower limit of quantification \[LLOQ\]) as assessed by the local laboratory, or a CMV DNA level below 500 IU/mL in plasma without evidence of CMV disease.

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-10-31
• Completion: 2028-01-31
• First posted: 2025-06-10
• Last updated: 2025-12-04

Locations

1 site across 1 country: South Korea