Maribavir for CMV in people with lymphoma or multiple myeloma receiving bispecific antibodies
Maribavir Treatment of Cytomegalovirus for Lymphoid Malignancy Patients Undergoing Bispecific Antibodies
This will test whether the oral antiviral maribavir can treat CMV reactivation in adults with lymphoma or multiple myeloma who are receiving bispecific antibody therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | Teclistamab, Elranatamab, Talquetamab, Cevostamab, Mosunetuzumab, Glofitamab, Epcoritamab, Odronextamab, prednisone |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07014319 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm, multicenter study gives oral maribavir to adults with multiple myeloma or specified B‑cell lymphomas who develop CMV reactivation while on bispecific antibody therapy. Eligible patients are ≥19 years old, receiving one of the listed bispecific antibodies, and have clinically significant CMV defined by end-organ disease or viremia ≥500 IU/mL. Patients will receive maribavir and be monitored for safety, tolerability, and virologic response during and after treatment. Primary outcomes focus on feasibility and safety in this heavily pretreated, immunocompromised population.
Who should consider this trial
Good fit: Adults (≥19) with multiple myeloma or specified B‑cell lymphomas who are receiving a listed bispecific antibody and develop clinically significant CMV reactivation (viremia ≥500 IU/mL on consecutive testing or CMV end‑organ disease).
Not a fit: Patients without CMV reactivation, those not on the specified bispecific antibodies, or individuals with contraindications to maribavir or CMV strains resistant to maribavir are unlikely to benefit.
Why it matters
Potential benefit: If successful, maribavir could provide an effective, oral, and better-tolerated option to control CMV in heavily pretreated patients on bispecific antibodies.
How similar studies have performed: Maribavir has demonstrated effectiveness in prior trials for refractory or resistant CMV and is approved for that indication, but its use specifically during bispecific antibody therapy is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
B. 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.
Exclusion Criteria:
* 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:
A. Creatinine clearance \<10 mL/min or requiring dialysis (Cockcroft-Gault formula used):
* Males: CrCl = (140 - age) × weight (kg) / (72 × creatinine \[mg/dL\])
* 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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Ja Min Byun, MD, PhD
- Email: jaminbyun@snu.ac.kr
- Phone: 82-2-2072-7215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.