A Phase 1/2 interventional study of ALVR106 and Placebo in Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection and Parainfluenza (PIV) Infection, sponsored by AlloVir. Terminated at 21 sites in United States. Open to participants aged 17 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by AlloVir · Phase 1/2, Interventional, and Treatment
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Among 21 studies in Paramyxoviridae Infections with a site in United States — 2 open to participants now, 2 under way, 1 of them phase 3. Paramyxoviridae Infections · United States.
Among the 21 studies in Paramyxoviridae Infections with a site in United States, this one is the 18th largest by enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2022, is the only one in phase 1/2, and was the 17th registered.
31 studies on the registry are indexed under Paramyxoviridae Infections; 3 are open to participants now.
Browse Paramyxoviridae Infections studies →2 of the 21 studies in Paramyxoviridae Infections with a site in United States are open now. Recruiting first, the newest first:
AstraZeneca · Sites in United States
Ages 18–55 · Healthy volunteers
Ansun Biopharma, Inc. · Sites in United States, Australia, China and 2 more countries
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 3 Paramyxoviridae Infections studies recruiting now, 2 set no upper age limit and 1 stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 17 Years to 75 Years · 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.
21 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 15 · Phase 2 4 · Phase 3 1
First in 2005; this study’s year is marked. 2 started in 2022.
This study's enrollment of 17 is below the median of 60 across 25 interventional studies indexed under Paramyxoviridae Infections.
Median enrollment 51 across the 20 interventional studies, 272 across the 1 observational. Of the 18 that completed or were terminated, 5 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 21 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 1 study filed under Paramyxoviridae Infections — fewer than ten, so there is no comparison to draw.
1 of the studies in Paramyxoviridae 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 |
|---|---|
| NCT07824622AstraZenecaStudy of Safety and PK of AZD0543 in Healthy Adults | 2027-03-24 |
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Among the 21 studies in Paramyxoviridae 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.
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).
The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT or SOT patients suffering from infection with any of the four targeted viruses (RSV, influenza, hMPV, and/or PIV) will be safe and demonstrate shorter time to resolution of the respiratory viral infection (as measured by resolution of symptoms and viral load clearance in nasal swab) compared to patients treated with placebo.
This trial will consist of two parts: Part A is Dose Escalation and Part B is Cohort Expansion.
31 studies on the registry are indexed under Paramyxoviridae Infections; 3 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 25 interventional studies indexed under Paramyxoviridae Infections.
Browse Paramyxoviridae Infections studies →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.
Compared within Paramyxoviridae Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Exclusion Criteria:
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.
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.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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.
Placebo, visually identical to ALVR106
Biological: Placebo
ALVR106, visually identical to placebo
Biological: ALVR106
Infusion, visually identical to placebo
Infusion, visually identical to ALVR106
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
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, requires in-patient 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 new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
Time frame: Day 1 up to 12 months
Change in Viral Load From Baseline to Day 28 (Part B)
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Time frame: Baseline and Day 28 (Part B)
Identify the Recommended Phase 2 Dose (RP2D) (Part A)
The RP2D was to be determined after the maximum tolerated dose was reached in Part A.
Time frame: Day 1 up to 12 months
Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)
Viral load was measured by quantitative polymerase chain reaction (PCR) of nasal swab specimens. The cycle threshold value categorizes the concentration of viral genetic material in a participant's swab specimen, and the cycle threshold value represents the number of PCR cycles required to amplify the viral genetic material (as measured by fluorescence) to a detectable level that is distinguishable from baseline fluorescence, providing an estimate of viral load. Lower cycle threshold values indicate higher viral load and high values indicate lower viral load. A positive change from baseline indicates a decrease in the viral load. The baseline measurement was from a pre-dose nasal swab.
Time frame: Baseline and Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)
Time frame: Day 1 up to 12 months
Percentage Reduction in Viral Load From Baseline to Month 6 (Part B)
Time frame: Day 1 and Month 6
Participants were enrolled at study centers in the United States and participated from March 2022 until January 2024.
| Milestone | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D | Part B Expansion Cohort |
|---|---|---|---|---|---|---|
| Started | 3 | 3 | 4 | 4 | 3 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 3 | 4 | 4 | 3 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Randomized not treated | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Sponsor terminated study | 0 | 0 | 0 | 1 | 2 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Missing | 1 | 3 | 2 | 1 | 1 | 0 |
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, requires in-patient 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 new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
| Participants | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D |
|---|---|---|---|---|---|
| Any TEAE | 2 | 3 | 4 | 4 | 3 |
| Any treatment-related TEAE | 2 | 1 | 0 | 0 | 0 |
| Any AESI | 1 | 1 | 0 | 1 | 1 |
| Any treatment-related AESI | 1 | 0 | 0 | 0 | 0 |
| Any SAE | 0 | 2 | 3 | 3 | 1 |
| Any treatment-related SAE | 0 | 0 | 0 | 0 | 0 |
| Any TEAE leading to study treatment discontinuation | 0 | 0 | 0 | 0 | 0 |
| Any TEAE leading to death | 0 | 0 | 1 | 1 | 0 |
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
No measurements were reported for this outcome.
The RP2D was to be determined after the maximum tolerated dose was reached in Part A.
| x 10^5 cells/kg | All Doses ALVR106 (Part A) |
|---|---|
| Identify the Recommended Phase 2 Dose (RP2D) (Part A) | NA |
Viral load was measured by quantitative polymerase chain reaction (PCR) of nasal swab specimens. The cycle threshold value categorizes the concentration of viral genetic material in a participant's swab specimen, and the cycle threshold value represents the number of PCR cycles required to amplify the viral genetic material (as measured by fluorescence) to a detectable level that is distinguishable from baseline fluorescence, providing an estimate of viral load. Lower cycle threshold values indicate higher viral load and high values indicate lower viral load. A positive change from baseline indicates a decrease in the viral load. The baseline measurement was from a pre-dose nasal swab.
| cycles | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D |
|---|---|---|---|---|---|
| Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A) | 8.60 ± NA | 4.40 ± NA | 8.43 ± 6.118 | 5.78 ± 4.696 | 7.47 ± 7.551 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Day 1 up to 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Placebo | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Part A ALVR106 Cohort 1: Dose A | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Part A ALVR106 Cohort 2: Dose B | 2/4 (50%) | 3/4 (75%) | 4/4 (100%) |
| Part A ALVR106 Cohort 3: Dose C | 2/4 (50%) | 3/4 (75%) | 4/4 (100%) |
| Part A ALVR106 Cohort 4: Dose D | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D |
|---|---|---|---|---|---|
| Acute myeloid leukaemia recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps) | — | 0/3 | 2/4 | 0/4 | 0/3 |
| PneumoniaInfections and infestations | — | 1/3 | 0/4 | 0/4 | 0/3 |
| COVID-19Infections and infestations | — | 1/3 | 0/4 | 0/4 | 0/3 |
| Oesophageal candidiasisInfections and infestations | — | 1/3 | 0/4 | 0/4 | 0/3 |
| OdynophagiaGastrointestinal disorders | — | 1/3 | 0/4 | 0/4 | 0/3 |
| SepsisInfections and infestations | — | 0/3 | 1/4 | 1/4 | 1/3 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | — | 0/3 | 0/4 | 1/4 | 1/3 |
| PyrexiaGeneral disorders | — | 0/3 | 0/4 | 1/4 | 1/3 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | — | 0/3 | 0/4 | 0/4 | 1/3 |
| AscitesGastrointestinal disorders | — | 0/3 | 0/4 | 0/4 | 1/3 |
| Event | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D |
|---|---|---|---|---|---|
| COVID-19Infections and infestations | 1/2 | 0/3 | 3/4 | 0/4 | 0/3 |
| Oral candidiasisInfections and infestations | 0/2 | 0/3 | 0/4 | 0/4 | 2/3 |
| PyrexiaGeneral disorders | 1/2 | 0/3 | 1/4 | 1/4 | 1/3 |
| Non-cardiac chest painGeneral disorders | 1/2 | 0/3 | 0/4 | 0/4 | 0/3 |
| White blood cell count decreasedInvestigations | 0/2 | 0/3 | 2/4 | 0/4 | 1/3 |
| Neutrophil count decreasedInvestigations | 0/2 | 0/3 | 2/4 | 0/4 | 0/3 |
| Blood lactate dehydrogenase increasedInvestigations | 1/2 | 0/3 | 0/4 | 0/4 | 0/3 |
| Neck painMusculoskeletal and connective tissue disorders | 0/2 | 0/3 | 0/4 | 2/4 | 0/3 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 1/2 | 0/3 | 0/4 | 1/4 | 0/3 |
| Acute graft versus host disease in skinImmune system disorders | 1/2 | 0/3 | 0/4 | 1/4 | 0/3 |
The modified intent-to-treat population for Part A which included all randomized participants who received any amount of ALVR106 or placebo and had confirmed virologic infection of interest at baseline (detectable viral load). One participant randomized to the placebo cohort did not receive study treatment and is not included. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the baseline analysis population.
| Age, Customized(Participants) | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D | Total |
|---|---|---|---|---|---|---|
| ≤ 18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| 19 - 70 years | 2 | 3 | 4 | 4 | 3 | 16 |
| ≥ 71 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 2 | 3 | 1 | 1 | 7 |
| Male | 2 | 1 | 1 | 3 | 2 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 2 | 3 | 4 | 4 | 2 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Part A: Placebo | Part A ALVR106 Cohort 1: Dose A | Part A ALVR106 Cohort 2: Dose B | Part A ALVR106 Cohort 3: Dose C | Part A ALVR106 Cohort 4: Dose D | Total |
|---|---|---|---|---|---|---|
| White | 1 | 3 | 4 | 4 | 3 | 15 |
| Not reported | 1 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2022 to primary completion in Jan 2024, 22 months.
Results were first posted in Jun 2024, 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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