A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT

Recruiting now · Phase 3

Conditions studied: Adenovirus Infections

In brief

This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia. A virologic response-driven approach to duration of treatment will be evaluated, in which randomized subjects are treated with either BCV or CDV until AdV viremia is confirmed as undetectable or until a maximum of 12 weeks of therapy, whichever occurs first. All subjects will be followed for a total of 24 weeks post-randomization, regardless of treatment assignment. Subjects will be assessed on a weekly basis through the end of treatment visit (EOT). Additional assessments will be performed at the test of cure (TOC) visit, which is 4 weeks after the last dose of study drug and at Weeks 12 and 24 post W1D1.

Key facts

Study ID

NCT07387367

Run by

SymBio Pharmaceuticals

People needed

180

Starts

2026-03-17

Expected to finish

2028-06-30

Last updated by the study team

2026-07-22

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form.
• Subject/Guardian willing and able to understand and provide written informed consent to participate in the study.
• In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection.
• Has adenoviremia, based on any of:
• AdV viremia DNA ≥10,000 IU/mL, OR
• Two consecutive and rising AdV viremia DNA results of ≥1,000 IU/mL at screening, OR
• AdV viremia DNA of ≥1,000 IU/mL, AND
• Lymphocyte count <180/mm3, OR 2. Received T cell depletion, cord blood, or haploidentical transplant, OR 3. prior alemtuzumab, OR 4. anti-thymocyte globulin (ATG)

You may not qualify if…

• Subject received an allo-HCT with a matched sibling donor
• Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug.
• Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components.
• Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time.
• Subject has participated in any other investigational study within 30 days (or within 5.5 half-lives of the investigational product, whichever is longer) before signing the informed consent form (ICF), is currently participating in another interventional treatment trial with an investigational agent or is using an investigational device at the time of Screening.

Where it is running

• Essen University Hospital — Essen, Germany (enrolling)
• Hospital Universitario La Paz — Madrid, Spain (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• CHU Sainte Justine Hospital — Montreal, Canada (enrolling)
• Perugia Hospital — Perugia, Italy (enrolling)
• Ospedale Pediatrico Bambino Gesu' — Rome, Italy (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
• Medical College of Wisconsin / Children's Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• Istituto Giannina Gaslini — Genova, Italy (enrolling)
• Dana-Farber Cancer Institute-Brighman and Women's — Boston, Massachusetts, United States (enrolling)
• Dana-Farber/Boston Children's Cancer and Blood Disorders Center — Boston, Massachusetts, United States (enrolling)
• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
• University of California Davis — Sacramento, California, United States (enrolling)
• St Louis Children's Hospital - Barnes Jewish Hospital — St Louis, Missouri, United States (enrolling)
• University of Nebraska — Omaha, Nebraska, United States (enrolling)
• Joseph M Sanzari Children's Hospital — Hackensack, New Jersey, United States (enrolling)
• Cohen Children's Medical Center — New Hyde Park, New York, United States (enrolling)
• Ann and Robert H Lurie Children's Hospital — Chicago, Illinois, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• University Hospital Frankfurt, am Main — Frankfurt, Germany (enrolling)
• Clinica Universidad de Navarra — Pamplona, Spain (enrolling)

Full record on ClinicalTrials.gov

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