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IV Brincidofovir versus IV Cidofovir for adenovirus after allogeneic stem cell transplant

A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir Versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)

Phase 3 Interventional SymBio Pharmaceuticals · NCT07387367

This compares IV brincidofovir to IV cidofovir to see if it clears adenovirus in the blood of adults and children after allogeneic stem cell transplant.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages2 Months and up
SexAll
SponsorSymBio Pharmaceuticals Industry-sponsored
Drugs / interventionsalemtuzumab
Locations61 sites (Phoenix, Arizona and 60 other locations)
Trial IDNCT07387367 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, two-arm Phase 3 trial compares intravenous brincidofovir (BCV) with intravenous cidofovir (CDV) in adult and pediatric recipients of allogeneic hematopoietic cell transplants who have adenovirus viremia. Subjects are randomized to receive BCV or CDV and are treated until plasma AdV DNA is undetectable on two consecutive weekly tests or until a maximum of 12 weeks of therapy, whichever occurs first. Assessments are performed weekly through end of treatment, with primary efficacy assessed at Week 5 Day 1 and follow-up visits at 4 weeks post-treatment and Weeks 12 and 24. Repeat treatment with the same randomized drug is allowed for recurrence, but no crossover between drugs is permitted.

Who should consider this trial

Good fit: Adults and children aged 2 months and older within 180 days of an allogeneic HCT who have adenovirus detected in plasma at or above protocol thresholds and meet high-risk criteria such as low lymphocyte counts or prior T-cell depletion are ideal candidates.

Not a fit: Patients who received a matched sibling donor transplant (excluded), who recently received high cumulative cidofovir (>5 mg/kg in prior 21 days), or who have contraindications/allergies to the study drugs are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, brincidofovir could clear adenovirus viremia more quickly than cidofovir, potentially lowering complications and improving outcomes after allo-HCT.

How similar studies have performed: Cidofovir has been used historically with variable results for adenovirus, and brincidofovir showed antiviral activity in earlier-phase studies, but randomized phase 3 evidence comparing the two is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form.
2. Subject/Guardian willing and able to understand and provide written informed consent to participate in the study.
3. In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection.
4. 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

1\. 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)

Exclusion Criteria:

1. Subject received an allo-HCT with a matched sibling donor
2. Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug.
3. Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components.
4. Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time.
5. 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 this trial is running

Phoenix, Arizona and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Adenovirus InfectionsBrincidofovirCidofovirAdenovirusallo-HCTBCV-PA02ENOVIA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.