Cytomegalovirus (CMV)Phase 2MALMBANCT07014319
Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies
A Phase 2 study testing Maribavir in people with Cytomegalovirus (CMV), run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cytomegalovirus (CMV)
- What is being tested?
- Maribavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2025to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥19 years of age at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures.
- ③ Subject is willing and able to adhere to the study visit schedule and protocol requirements.
- ④ Subject has documented diagnosis of multiple myeloma, follicular lymphoma, or large B-cell lymphoma (including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or transformed marginal zone lymphoma), and is receiving one of the following bispecific antibodies: Multiple Myeloma: Teclistamab, Elranatamab, Talquetamab, Cevostamab, ABBV383 Lymphomas: Mosunetuzumab, Glofitamab, Epcoritamab, Odronextamab
- ⑤ Subject has documented clinically significant CMV infection, defined as: A. Onset of CMV end-organ disease (Appendix 1), or B. Initiation of anti-CMV pre-emptive therapy based on documented CMV viremia ≥500 IU/mL in two consecutive assessments (≥1 day apart) and the clinical condition of the subject Note: Prior therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir is allowed.
- ECOG performance status of 0, 1, or 2. ⑦ Individual of childbearing potential (IOCBP) must: A. Have two negative pregnancy tests before study treatment, and agree to ongoing testing.
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- Commit to true abstinence or use two forms of contraception (one highly effective + one barrier method) starting 28 days prior to treatment, during treatment, and for 90 days after the last dose.
- Note: Definition of IOCBP includes menstruating individuals who are not postmenopausal for 12+ months or have not undergone permanent sterilization.
- ⑧ Male subjects must: A. Practice true abstinence (monthly verified) or use a condom with partners who are pregnant or of childbearing potential during treatment, dose interruptions, and for 90 days after last dose, regardless of vasectomy status.
- ⑨ Male subjects must not donate sperm during treatment and for 90 days after the last dose.
- ⑩ Female subjects must not donate eggs during treatment and for 90 days after the last dose.
Who cannot join
- Requires ganciclovir, valganciclovir, foscarnet, or cidofovir for non-CMV indications or requires co-administration with maribavir.
- Known hypersensitivity to maribavir. ③ CMV disease involving the CNS (retinitis alone is allowed). ④ Received allogeneic SCT within 1 year or autologous SCT within 12 weeks prior to study treatment.
- Allogeneic SCT recipients must not have active GVHD. ⑤ Any significant medical condition, infection, lab abnormality, or psychiatric illness posing unacceptable risk.
- Any condition that may confound data interpretation. ⑦ Any of the following laboratory abnormalities:
- Creatinine clearance <10 mL/min or requiring dialysis (Cockcroft-Gault formula used):
- Males: CrCl = (140 - age) × weight (kg) / (72 × creatinine [mg/dL])
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- Females: Multiply above result by 0.85 B. AST or ALT >5 × ULN C. Total bilirubin >3 × ULN (except Gilbert's syndrome)
- Gastrointestinal disease or surgery (e.g., gastric bypass) that affects maribavir absorption.
- Severe vomiting, diarrhea, or GI illness within 24 hours before first dose. ⑩ Use of immunosuppressive medication within 14 days before study treatment, except: A. Intranasal, inhaled, topical, or local corticosteroid injections B. Systemic corticosteroids ≤10 mg/day of prednisone or equivalent C. Premedication for hypersensitivity (e.g., CT scan premed) ⑪ Requires mechanical ventilation or vasopressors at enrollment. ⑫ Positive for HIV, active or chronic HBV, active HAV or HCV: A. Known HIV infection B. Positive HBsAg (acute or chronic); HBV DNA PCR required for anti-HBcAb(+) patients.
- EXCEPTION: Isolated anti-HBs with known HBV vaccination
- EXCEPTION: anti-HBc(+), HBsAg(-), anti-HBsAb(-) with negative HBV DNA C. HCV antibody and RNA positive ⑬ Pregnant, breastfeeding, or planning pregnancy during study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Ja Min Byun, MD, PhD, 82-2-2072-7215, jaminbyun@snu.ac.kr
About this study
Official title: Maribavir Treatment of Cytomegalovirus for Lymphoid Malignancy Patients Undergoing Bispecific Antibodies
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
Read the 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)
- Being tested
- Maribavir
- Keywords
- CMV, MM, Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaribavirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Maribavir arm | Experimental | The Maribavir arm includes patients with a confirmed diagnosis of multiple myeloma, follicular lymphoma, or large B-cell lymphomas (including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or transformed marginal zone lymphoma) who are receiving bispecific antibody therapy. Patients must have documented clinically significant CMV infection, defined by either CMV end-organ disease or initiation of pre-emptive therapy based on plasma CMV viremia ≥ 500 IU/mL in two consecutive assessments and relevant clinical findings. Receives: Drug: Maribavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate to Achieve CMV DNA Titer Reduction to < 500 IU/mL
The proportion (%) of patients whose plasma CMV DNA titer decreases to below 500 IU/mL at any point during maribavir treatment, as assessed by local laboratory testing.
Measured: From Week 1 to CMV clearance
Time to Achieve CMV DNA Titer Reduction to < 500 IU/mL
The time (in days) from the initiation of maribavir treatment to the first documented plasma CMV DNA titer of < 500 IU/mL, confirmed by local laboratory testing.
Measured: From Week 1 to CMV clearance
Safety outcomes
Adverse events (AEs) will be evaluated in terms of type, frequency, seriousness, and severity, and their relationship to maribavir will be assessed. All AEs will be graded according to the NCI CTCAE criteria, and their causality with study drug will be determined by the investigator.
Measured: From Screening to Week 18
Secondary outcomes (3)
Rate to Achieve ≥1 log₁₀ Decrease in CMV DNA Titer From Baseline
The proportion (%) of patients who achieve a reduction of ≥1 log₁₀ in plasma CMV DNA titer from baseline (i.e., the time of maribavir initiation), as assessed by local laboratory testing.
Measured: From Week 1 to CMV clearance
Time to Achieve ≥1 log₁₀ Reduction in Plasma CMV DNA Titer From Baseline
The time (in days) from maribavir initiation to the first documented ≥1 log₁₀ decrease in plasma CMV DNA titer from baseline, as assessed by local laboratory testing.
Measured: From Week 1 to CMV clearance
Rate of Breakthrough CMV Disease
The proportion (%) of patients who develop CMV disease during or after maribavir treatment, despite initial virologic control or response.
Measured: From Maribavir Initiation to End of Treatment at 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start3 Nov 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus (CMV)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JaMin Byun, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014319
- Sponsor's protocol ID
- 2505-076-1641
- Acronym
- MALMBA
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maribavir Treatment of Cytomegalovirus for Lymphoid Malignancy Patients Undergoing Bispecific Antibodies
- ClinicalTrials.gov ID
- NCT07014319
- Acronym / sponsor ID
- MALMBA / 2505-076-1641
- Conditions
- Cytomegalovirus (CMV)
- Keywords
- CMV, MM, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maribavir arm | Experimental | Drug: MaribavirThe Maribavir arm includes patients with a confirmed diagnosis of multiple myeloma, follicular lymphoma, or large B-cell lymphomas (including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or transformed marginal zone lymphoma) who are receiving bispecific antibody therapy. Patients must have documented clinically significant CMV infection, defined by either CMV end-organ disease or initiation of pre-emptive therapy based on plasma CMV viremia ≥ 500 IU/mL in two consecutive assessments and relevant clinical findings. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is ≥19 years of age at the time of signing the informed consent form (ICF).
- ③ Subject is willing and able to adhere to the study visit schedule and protocol requirements.
- ④ Subject has documented diagnosis of multiple myeloma, follicular lymphoma, or large B-cell lymphoma (including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or transformed marginal zone lymphoma), and is receiving one of the following bispecific antibodies: Multiple Myeloma: Teclistamab, Elranatamab, Talquetamab, Cevostamab, ABBV383 Lymphomas: Mosunetuzumab, Glofitamab, Epcoritamab, Odronextamab
- ⑤ Subject has documented clinically significant CMV infection, defined as: A. Onset of CMV end-organ disease (Appendix 1), or B. Initiation of anti-CMV pre-emptive therapy based on documented CMV viremia ≥500 IU/mL in two consecutive assessments (≥1 day apart) and the clinical condition of the subject Note: Prior therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir is allowed.
- Commit to true abstinence or use two forms of contraception (one highly effective + one barrier method) starting 28 days prior to treatment, during treatment, and for 90 days after the last dose.
Key exclusion criteria (11 listed)
- Requires ganciclovir, valganciclovir, foscarnet, or cidofovir for non-CMV indications or requires co-administration with maribavir.
- Allogeneic SCT recipients must not have active GVHD. ⑤ Any significant medical condition, infection, lab abnormality, or psychiatric illness posing unacceptable risk.
- Any condition that may confound data interpretation. ⑦ Any of the following laboratory abnormalities:
- Creatinine clearance <10 mL/min or requiring dialysis (Cockcroft-Gault formula used):
- Males: CrCl = (140 - age) × weight (kg) / (72 × creatinine [mg/dL])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaribavirParticipants 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. | Drug | Maribavir arm |
Primary outcome
Rate to Achieve CMV DNA Titer Reduction to < 500 IU/mL
Time frame: From Week 1 to CMV clearance
The proportion (%) of patients whose plasma CMV DNA titer decreases to below 500 IU/mL at any point during maribavir treatment, as assessed by local laboratory testing.
Time to Achieve CMV DNA Titer Reduction to < 500 IU/mL
Time frame: From Week 1 to CMV clearance
The time (in days) from the initiation of maribavir treatment to the first documented plasma CMV DNA titer of < 500 IU/mL, confirmed by local laboratory testing.
Safety outcomes
Time frame: From Screening to Week 18
Adverse events (AEs) will be evaluated in terms of type, frequency, seriousness, and severity, and their relationship to maribavir will be assessed. All AEs will be graded according to the NCI CTCAE criteria, and their causality with study drug will be determined by the investigator.
3 secondary outcomes
Rate to Achieve ≥1 log₁₀ Decrease in CMV DNA Titer From Baseline
Time frame: From Week 1 to CMV clearance
Time to Achieve ≥1 log₁₀ Reduction in Plasma CMV DNA Titer From Baseline
Time frame: From Week 1 to CMV clearance
Rate of Breakthrough CMV Disease
Time frame: From Maribavir Initiation to End of Treatment at 4 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maribavir in people with Cytomegalovirus (CMV), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ja Min Byun, MD, PhD (82-2-2072-7215, jaminbyun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate to Achieve CMV DNA Titer Reduction to < 500 IU/mL (time frame: From Week 1 to CMV clearance). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.