Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
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ClinicalTrials.gov Identifier: NCT05179057 |
Recruitment Status :
Recruiting
First Posted : January 5, 2022
Last Update Posted : February 9, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenovirus Infection | Drug: Posoleucel Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with option for blinded crossover to assess the safety and efficacy of posoleucel as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation |
Actual Study Start Date : | May 11, 2022 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | June 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Posoleucel + SoC
Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
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Drug: Posoleucel
Administered as 2-4 milliliter infusion, visually identical to placebo |
Placebo Comparator: Placebo + SoC
Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria
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Drug: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel |
- Proportion of participants with undetectable adenovirus infection [ Time Frame: 29 days ]Primary Efficacy
- Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 34 weeks ]Primary Safety
- Overall disease progression or non-relapse mortality [ Time Frame: 34 weeks ]Key Secondary Efficacy
- Mean area under the curve (AUC) AdV viral load [ Time Frame: 29 days ]Other Secondary Efficacy
- Proportion of participants who achieve AdV viremia <400 copies/mL [ Time Frame: 29 days ]Other Secondary Efficacy
- Time to undetectable AdV viremia (less than LLOQ) [ Time Frame: 34 weeks ]Other Secondary Efficacy
- Incidence of AdV disease recurrence [ Time Frame: 34 weeks ]Other Secondary Efficacy

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Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female 1 year of age or older
- Undergone allogeneic cell transplantation ≥21 days prior to dosing
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Meet one of the below criteria:
- AdV viremia DNA ≥10,000 copies/mL, OR
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AdV viremia DNA results of ≥1,000 copies/mL, AND
- has absolute lymphocyte count <180/mm3, OR
- has received T cell depletion OR
- had a cord blood transplant.
Exclusion Criteria:
- Grade >2 acute GVHD
- Ongoing therapy with high-dose systemic corticosteroids
- Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
- Pregnant or lactating female unwilling to discontinue nursing prior to randomization
- History of severe prior reactions to blood product transfusions.
NOTE: Other protocol-defined inclusion/exclusion criterion may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05179057
Contact: Chrissy Pelland | +1 833-409-2281 | ClinicalTrials@allovir.com |

Responsible Party: | AlloVir |
ClinicalTrials.gov Identifier: | NCT05179057 |
Other Study ID Numbers: |
P-105-303 |
First Posted: | January 5, 2022 Key Record Dates |
Last Update Posted: | February 9, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Allogeneic Hematopoietic Cell Transplant Adenoviremia Adenovirus Stem Cell Transplant |
Posoleucel ALVR105 Bone Marrow Transplant |
Infections Communicable Diseases Adenoviridae Infections Disease Attributes |
Pathologic Processes DNA Virus Infections Virus Diseases |