A Phase 3 interventional study of Posoleucel and Placebo in Adenovirus Infection, sponsored by AlloVir. Terminated at 47 sites in 6 countries. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by AlloVir · Phase 3, Interventional, and Treatment
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Among 78 studies in Adenoviridae Infections with a site in United States — 17 open to participants now, 21 under way, 2 of them phase 3. Adenoviridae Infections · United States.
Among the 78 studies in Adenoviridae Infections with a site in United States, this one is the 20th largest by enrollment of the 68 interventional ones that give a count, is one of 4 that started in 2022, is one of 6 in phase 3, and was the 66th registered.
136 studies on the registry are indexed under Adenoviridae Infections; 34 are open to participants now.
Browse Adenoviridae Infections studies →17 of the 78 studies in Adenoviridae Infections with a site in United States are open now. Recruiting first, the newest first:
New York Medical College · Sites in United States
Ages 1 days–30 yrs
Dispatch Biotherapeutics · Sites in United States
Ages 18+
SymBio Pharmaceuticals · Sites in United States, Austria, Belgium and 10 more countries
Ages 2 mo+
Jessie L. Alexander · Sites in United States
Ages 1 mo–65 yrs
Monica Bhatia · Sites in United States
Ages 3 mo–26 yrs
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Adenoviridae Infections studies recruiting now, 9 (36%) set no upper age limit and 12 (48%) stop at 75 or younger; 17 take children under 18; 4 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 43 · Phase 2 30 · Phase 3 9 · Phase 4 1
First in 2002; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 57 is above the median of 30 across 109 interventional studies indexed under Adenoviridae Infections.
Median enrollment 27 across the 68 interventional studies, 436 across the 8 observational. Of the 46 that completed or were terminated, 18 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 78 have an industry lead sponsor. The 10 most frequent:
AlloVir is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
AlloVir has 6 studies filed under Adenoviridae Infections — fewer than ten, so there is no comparison to draw.
6 of the studies in Adenoviridae Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04673942EpicentRx, Inc.A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors | 2026-12-01 |
| NCT03266627New York Medical CollegeAdenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection | 2026-12-31 |
| NCT02048332Children's Hospital Medical Center, CincinnatiDonor-Derived Viral Specific T-cells (VSTs) | 2027-01 |
| NCT05271318TILT Biotherapeutics Ltd.Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. | 2027-03 |
| NCT03665675Sumithira VasuDonor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT | 2027-03-20 |
Add all 6 to your calendar (.ics) → With an account.
Among the 78 studies in Adenoviridae Infections with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meet one of the below criteria:
AdV viremia DNA results of ≥1,000 copies/mL, AND
Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criterion may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
Drug: Posoleucel
Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria
Drug: Placebo
Administered as 2-4 milliliter infusion, visually identical to placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel
Number of Participants With Undetectable Adenovirus Infection
Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).
Time frame: Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
Time frame: Up to 34 weeks
Number of Participants With Overall Disease Progression
Time frame: From Day 29 up to Week 10
Area Under the Curve (AUC) Adenovirus Viral Load
Time frame: Pre-dose and Day 29
Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29
Time frame: Day 29
Time to Undetectable Adenovirus Viremia (Less Than LLOQ)
Time frame: Pre-dose to 34 weeks
Number of Participants With Adenovirus Disease Recurrence
Time frame: 34 weeks
Participants were enrolled at 47 study centers in the United States, Canada, Italy, Spain, Sweden, and the United Kingdom, and participated from April 2022 to January 2024.
| Milestone | Posoleucel, Then Placebo | Placebo, Then Posoleucel |
|---|---|---|
| Started | 30 | 27 |
| Received primary study treatment | 28 | 23 |
| Met cross-over eligibility criteria | 4 | 5 |
| Received cross-over treatment | 4 | 5 |
| Completed | 10 | 13 |
| Not completed | 20 | 14 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Non-compliance with protocol requirements or study-related procedures | 1 | 0 |
| Withdrew: Study terminated | 13 | 7 |
| Withdrew: Discontinuation or withdrawal by participants/parent/legal guardian | 2 | 2 |
| Withdrew: Never received primary or cross-over study treatment | 1 | 3 |
Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).
| Participants | Posoleucel, Then Placebo | Placebo, Then Posoleucel |
|---|---|---|
| Number of Participants With Undetectable Adenovirus Infection | 11 | 9 |
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
| Participants | Posoleucel (Primary Study Period) | Placebo (Primary Study Period) | Posoleucel (Cross-over Period) | Placebo (Cross-over Period) |
|---|---|---|---|---|
| Any TEAE | 27 | 23 | 5 | 3 |
| Any TEAE related to study treatment | 7 | 9 | 1 | 1 |
| Any AESI | 6 | 9 | 1 | 2 |
| Any SAE | 16 | 16 | 3 | 1 |
| Any SAE related to study treatment | 1 | 1 | 1 | 1 |
| Any TEAE leading to study treatment discontinuation | 2 | 1 | 0 | 2 |
| Any TEAE leading to study discontinuation | 1 | 2 | 0 | 1 |
| Any TEAE leading to death | 2 | 1 | 0 | 1 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Up to 34 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Posoleucel (Primary Study Period) | 2/28 (7.1%) | 16/28 (57.1%) | 27/28 (96.4%) |
| Placebo (Primary Study Period) | 1/23 (4.3%) | 16/23 (69.6%) | 23/23 (100%) |
| Posoleucel (Cross-over Period) | 0/5 (0%) | 3/5 (60%) | 5/5 (100%) |
| Placebo (Cross-over Period) | 1/4 (25%) | 1/4 (25%) | 3/4 (75%) |
| Event | Posoleucel (Primary Study Period) | Placebo (Primary Study Period) | Posoleucel (Cross-over Period) | Placebo (Cross-over Period) |
|---|---|---|---|---|
| Acute graft versus host diseaseImmune system disorders | 0/28 | 0/23 | 0/5 | 1/4 |
| Hepatic failureHepatobiliary disorders | 0/28 | 0/23 | 0/5 | 1/4 |
| Cerebral haemorrhageNervous system disorders | 0/28 | 0/23 | 0/5 | 1/4 |
| SepsisInfections and infestations | 0/28 | 1/23 | 1/5 | 0/4 |
| BacteraemiaInfections and infestations | 0/28 | 0/23 | 1/5 | 0/4 |
| SinusitisInfections and infestations | 0/28 | 0/23 | 1/5 | 0/4 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/28 | 0/23 | 1/5 | 0/4 |
| Graft versus host diseaseImmune system disorders | 0/28 | 0/23 | 1/5 | 0/4 |
| HaematuriaRenal and urinary disorders | 0/28 | 0/23 | 1/5 | 0/4 |
| Autoimmune haemolytic anaemiaBlood and lymphatic system disorders | 0/28 | 0/23 | 1/5 | 0/4 |
| Event | Posoleucel (Primary Study Period) | Placebo (Primary Study Period) | Posoleucel (Cross-over Period) | Placebo (Cross-over Period) |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 6/28 | 5/23 | 2/5 | 1/4 |
| PyrexiaGeneral disorders | 10/28 | 8/23 | 1/5 | 0/4 |
| HypokalaemiaMetabolism and nutrition disorders | 9/28 | 6/23 | 1/5 | 1/4 |
| VomitingGastrointestinal disorders | 8/28 | 4/23 | 0/5 | 0/4 |
| COVID-19Infections and infestations | 3/28 | 1/23 | 0/5 | 1/4 |
| Epstein-Barr virus infection reactivationInfections and infestations | 1/28 | 1/23 | 0/5 | 1/4 |
| DiarrhoeaGastrointestinal disorders | 5/28 | 4/23 | 1/5 | 1/4 |
| Blood bicarbonate decreasedInvestigations | 1/28 | 2/23 | 0/5 | 1/4 |
| Activated partial thromboplastin time prolongedInvestigations | 1/28 | 0/23 | 0/5 | 1/4 |
| HypermagnesaemiaMetabolism and nutrition disorders | 2/28 | 0/23 | 1/5 | 1/4 |
| Age, Continuous(years) | Posoleucel, Then Placebo | Placebo, Then Posoleucel | Total |
|---|---|---|---|
| Mean | 16.2 ± 17.10 | 14.9 ± 15.80 | 15.6 ± 16.36 |
| Sex: Female, Male(Participants) | Posoleucel, Then Placebo | Placebo, Then Posoleucel | Total |
|---|---|---|---|
| Female | 9 | 11 | 20 |
| Male | 21 | 16 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Posoleucel, Then Placebo | Placebo, Then Posoleucel | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 22 | 23 | 45 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Race/Ethnicity, Customized(Participants) | Posoleucel, Then Placebo | Placebo, Then Posoleucel | Total |
|---|---|---|---|
| Asian | 3 | 2 | 5 |
| Black or African American | 3 | 1 | 4 |
| White | 19 | 20 | 39 |
| Not Reported | 3 | 1 | 4 |
| Other | 2 | 3 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2022 to primary completion in Jan 2024, 21 months.
Results were first posted in May 2024, 3 months after primary completion.
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Studies of the drug tested here: Posoleucel
AlloVir