A Phase 2/3 interventional study of Posoleucel (ALVR105) in Adenovirus Infection, BK Virus Infection and Cytomegalovirus Infections, sponsored by AlloVir. Completed at 16 sites in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by AlloVir · Phase 2/3, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 35th largest by enrollment of the 68 interventional ones that give a count, is one of 5 that started in 2021, is one of 3 in phase 2/3, and was the 62nd 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: 1 Year and older · 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. 5 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 26 is below 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 2 study to evaluate posoleucel (ALVR105, formerly 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, an open label Phase 2 cohort described in this posting, and a randomized, placebo controlled Phase 3 cohort described in NCT05305040. In the Phase 2 part, 25 to 35 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 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.
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.
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
Biological: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14
Time frame: Through Week 14
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 26.
Time frame: Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Time frame: Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 14 and Week 26 (6 endpoints each at Week 14 and Week 26).
Time frame: Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV)
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Time frame: Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV)
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Time frame: through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6)
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Time frame: Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV)
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Time frame: Through Week 26
Rates of Overall and Non-Relapse Mortality
The number of mortality events due to non-relapse causes through Week 52.
Time frame: Through Week 52
| Milestone | Posoleucel (ALVR105) |
|---|---|
| Started | 26 |
| Completed | 16 |
| Not completed | 10 |
| Withdrew: Death | 4 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Physician decision | 2 |
| Withdrew: Lost to follow-up | 1 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease | 3 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 26.
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease | 7 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV) | 1 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 14 and Week 26 (6 endpoints each at Week 14 and Week 26).
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV | 0 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV) | 5 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV) | 1 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6) | 0 |
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
| Participants | Posoleucel (ALVR105) |
|---|---|
| Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV) | 0 |
The number of mortality events due to non-relapse causes through Week 52.
| Participants | Posoleucel (ALVR105) |
|---|---|
| Overall Mortality | 4 |
| Non-Relapse Mortality | 0 |
Collected over All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Posoleucel (ALVR105) | 4/26 (15.4%) | 19/26 (73.1%) | 26/26 (100%) |
| Event | Posoleucel (ALVR105) |
|---|---|
| SepsisInfections and infestations | 3/26 |
| Abdominal PainGastrointestinal disorders | 2/26 |
| PyrexiaGeneral disorders | 2/26 |
| Graft versus host disease in gastrointestinal tractImmune system disorders | 2/26 |
| Cytomegalovirus infection reactivationInfections and infestations | 2/26 |
| AdrenoleukodystrophyCongenital, familial and genetic disorders | 1/26 |
| DiarrhoeaGastrointestinal disorders | 1/26 |
| Pancreatitis AcuteGastrointestinal disorders | 1/26 |
| Pancreatitis NecrotisingGastrointestinal disorders | 1/26 |
| Acute graft versus host disease in skinImmune system disorders | 1/26 |
| Event | Posoleucel (ALVR105) |
|---|---|
| DiarrhoeaGastrointestinal disorders | 16/26 |
| Acute graft versus host disease in skinImmune system disorders | 10/26 |
| Abdominal PainGastrointestinal disorders | 6/26 |
| Weight decreasedInvestigations | 6/26 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 6/26 |
| TremorNervous system disorders | 6/26 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 6/26 |
| AnaemiaBlood and lymphatic system disorders | 5/26 |
| ConstipationGastrointestinal disorders | 5/26 |
| NauseaGastrointestinal disorders | 5/26 |
Analysis Population will include all patients who received posoleucel.
| Age, Categorical(Participants) | Posoleucel (ALVR105) |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 17 |
| >=65 years | 8 |
| Age, Continuous(years) | Posoleucel (ALVR105) |
|---|---|
| Median | 59.5 (14 to 76) |
| Sex: Female, Male(Participants) | Posoleucel (ALVR105) |
|---|---|
| Female | 12 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Posoleucel (ALVR105) |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Posoleucel (ALVR105) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 3 |
| White | 18 |
| More than one race | 3 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Posoleucel (ALVR105) |
|---|---|
| United States | 26 |
| Underlying Disease(Participants) | Posoleucel (ALVR105) |
|---|---|
| Leukemia | 17 |
| Myelodysplasia/Myeloproliferative | 3 |
| Lymphoma | 2 |
| Sickle Cell Anemia | 2 |
| Other | 2 |
| Type of Transplant(Participants) | Posoleucel (ALVR105) |
|---|---|
| Haploidentical | 12 |
| Mismatched Unrelated | 9 |
| Matched Unrelated | 4 |
| Umbilical Cord Blood | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Jan 2023, 24 months.
Results were first posted in May 2024, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Posoleucel
AlloVir