A Phase 2/3 interventional study of Posoleucel (ALVR105) and Placebo in Adenovirus Infection, BK Virus Infection and Cytomegalovirus Infections, sponsored by AlloVir. Terminated at 88 sites in 10 countries. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by AlloVir · Phase 2/3, Interventional, and Prevention
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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 7th largest by enrollment of the 68 interventional ones that give a count, is one of 4 that started in 2022, is one of 3 in phase 2/3, and was the 69th 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 451 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 is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.
There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.
Key Inclusion Criteria:
Meet one or more of the following criteria at the time of randomization:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered as 2-4 milliliter infusion, visually identical to placebo
Biological: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Biological: Placebo
Administered as 2-4 milliliter infusion, visually identical to placebo
Also known as: Viralym-M
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).
Time frame: Through Week 14
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26
The number of clinically significant infections or episodes of end-organ disease per participant due to AdV, BKV, CMV, EBV, HHV-6, or JCV.
Time frame: Through Week 26
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus
The number of participants with clinically significant infections or episodes of end-organ disease due to each of the following viruses: AdV, BKV, CMV, EBV, HHV-6, or JCV.
Time frame: Through Week 14
Participants at high risk for viral infection after allogeneic Hematopoietic Cell Transplant were enrolled in the Phase 3 portion of study P-105-202 between Mar 2022 and Jan 2024. The Phase 3 study was discontinued in Dec 2023 after futility analysis of the Primary Outcome Measure. No safety concerns were identified. The Phase 2 portion of study P-105-202 is reported under NCT number NCT04693637.
| Milestone | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| Started | 225 | 226 |
| Participants dosed (safety population) | 188 | 189 |
| Completed | 100 | 101 |
| Not completed | 125 | 125 |
| Withdrew: Not dosed | 37 | 37 |
| Withdrew: Study closure | 34 | 46 |
| Withdrew: Death | 14 | 13 |
| Withdrew: Withdrawal by subject | 15 | 10 |
| Withdrew: Other | 13 | 10 |
| Withdrew: Primary malignancy relapse | 3 | 4 |
| Withdrew: Adverse event | 3 | 3 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Graft versus host disease | 2 | 0 |
| Withdrew: Investigator's decision | 1 | 1 |
| Withdrew: Covid-19 reasons | 1 | 0 |
The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).
| Infections/Episodes per participant | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14 | 0.2 ± 0.44 | 0.2 ± 0.42 |
The number of clinically significant infections or episodes of end-organ disease per participant due to AdV, BKV, CMV, EBV, HHV-6, or JCV.
No measurements were reported for this outcome.
The number of participants with clinically significant infections or episodes of end-organ disease due to each of the following viruses: AdV, BKV, CMV, EBV, HHV-6, or JCV.
| participants | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| AdV | 3 | 2 |
| BKV | 2 | 2 |
| CMV | 16 | 19 |
| EBV | 10 | 6 |
| HHV-6 | 0 | 0 |
| JCV | 0 | 0 |
Collected over Day 1 through Week 26.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Posoleucel (ALVR105) | 18/188 (9.6%) | 88/188 (46.8%) | 180/188 (95.7%) |
| Placebo | 19/189 (10.1%) | 86/189 (45.5%) | 184/189 (97.4%) |
| Event | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| PyrexiaGeneral disorders | 4/188 | 12/189 |
| Graft versus host disease in gastrointestinal tractImmune system disorders | 7/188 | 7/189 |
| DiarrhoeaGastrointestinal disorders | 6/188 | 4/189 |
| Febrile neutropeniaBlood and lymphatic system disorders | 4/188 | 6/189 |
| Acute myeloid leukaemia recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/188 | 6/189 |
| COVID-19Infections and infestations | 5/188 | 4/189 |
| SepsisInfections and infestations | 5/188 | 2/189 |
| Acute graft versus host disease in skinImmune system disorders | 4/188 | 2/189 |
| PneumoniaInfections and infestations | 4/188 | 4/189 |
| Acute kidney injuryRenal and urinary disorders | 4/188 | 1/189 |
| Event | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 46/188 | 37/189 |
| NauseaGastrointestinal disorders | 36/188 | 22/189 |
| Acute graft versus host disease in skinImmune system disorders | 36/188 | 27/189 |
| PyrexiaGeneral disorders | 33/188 | 36/189 |
| Blood creatinine increasedInvestigations | 30/188 | 22/189 |
| CoughRespiratory, thoracic and mediastinal disorders | 30/188 | 20/189 |
| VomitingGastrointestinal disorders | 29/188 | 21/189 |
| AnaemiaBlood and lymphatic system disorders | 26/188 | 24/189 |
| Abdominal painGastrointestinal disorders | 25/188 | 16/189 |
| Graft versus host disease in gastrointestinal tractImmune system disorders | 24/188 | 16/189 |
Safety Population: included all participants who received at least one dose of posoleucel or placebo.
| Age, Continuous(years) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| Median | 55.0 (1 to 77) | 53.0 (0 to 75) | 54.0 (0 to 77) |
| Sex: Female, Male(Participants) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| Female | 78 | 66 | 144 |
| Male | 110 | 123 | 233 |
| Ethnicity (NIH/OMB)(Participants) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 24 | 37 |
| Not Hispanic or Latino | 143 | 144 | 287 |
| Unknown or Not Reported | 32 | 21 | 53 |
| Race/Ethnicity, Customized(Participants) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaskan Native | 1 | 1 | 2 |
| Asian | 25 | 21 | 46 |
| Black or African American | 7 | 5 | 12 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| White | 118 | 131 | 249 |
| Other | 9 | 8 | 17 |
| Unknown | 27 | 22 | 49 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2022 to primary completion in Jan 2024, 22 months.
Results were first posted in May 2024, 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Posoleucel
AlloVir