Respiratory Tract Viral InfectionsPhase 1/2NCT04933968
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
A Phase 1/2 study testing ALVR106 in people with Respiratory Tract Viral Infections and Human Metapneumovirus (hMPV) Infection, run by AlloVir at 21 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection
- What is being tested?
- ALVR106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 21 sitesUnited States
- Study dates
- 21 Mar 2022to 31 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergone hematopoietic cell transplantation (HCT) ≥21 days or solid organ transplantation (SOT) ≥28 days prior to study treatment administration
- Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
- Diagnosis of Upper or mild Lower Respiratory Tract Infection
Who cannot join
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
- Infection by novel coronavirus disease 2019 (COVID-19)
- For HCT patients, evidence of Grade >2 GVHD; and for SOT patients, any history or evidence of GVHD
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Northside Hospital
Atlanta, Georgia, 30342
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
University of North Carolina - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
City of Hope
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27708
University of Florida - Division of Hematology & Oncology
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
MD Anderson
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Cancer Center
Kansas City, Kansas, 64116.
University of Miami - Sylvester Cancer Center
Miami, Florida, 33136
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Cancer Center
Nashville, Tennessee, 37212
Virginia Commonwealth University
Richmond, Virginia, 23298
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, 85260
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Wake Forest
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
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).
Read the detailed description
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.
- Conditions
- Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection, Respiratory Syncytial Viral (RSV) Infection, Influenza Infection
- Being tested
- ALVR106, Placebo
- Keywords
- Respiratory virus, Hematopoietic Cell Transplant, Upper Respiratory Tract Infection, Bone Marrow Transplant, Human Metapneumovirus Infection, Parainfluenza, Respiratory Syncytial Virus (RSV), Multi-virus specific T cells (VST), Solid Organ Transplant (SOT)
- Medical subject headings
- Infections, Paramyxoviridae Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALVR106Biological
Infusion, visually identical to placebo
PlaceboBiological
Infusion, visually identical to ALVR106
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, visually identical to ALVR106 Receives: Biological: Placebo |
| ALVR106 | Active comparator | ALVR106, visually identical to placebo Receives: Biological: ALVR106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and Day 28 (Part B)
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline and Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)
Measured: Day 1 up to 12 months
Percentage Reduction in Viral Load From Baseline to Month 6 (Part B)
Measured: Day 1 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start21 Mar 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Strategic sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract Viral InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlloVir
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933968
- Sponsor's protocol ID
- P-106-001
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2021
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
PubMed 31004020Papayanni PG, Koukoulias K, Kuvalekar M, Watanabe A, Velazquez Y, Ramos CA, Leen AM, Vasileiou S. T cell immune profiling of respiratory syncytial virus for the development of a targeted immunotherapy. Br J Haematol. 2023 Aug;202(4):874-878. doi: 10.1111/bjh.18933. Epub 2023 Jun 15.
PubMed 37323051
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
- ClinicalTrials.gov ID
- NCT04933968
- Acronym / sponsor ID
- P-106-001
- Conditions
- Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection, Respiratory Syncytial Viral (RSV) Infection, Influenza Infection
- Keywords
- Respiratory virus, Hematopoietic Cell Transplant, Upper Respiratory Tract Infection, Bone Marrow Transplant, Human Metapneumovirus Infection, Parainfluenza, Respiratory Syncytial Virus (RSV), Multi-virus specific T cells (VST)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic sponsor decision
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AlloVirIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboPlacebo, visually identical to ALVR106 |
| ALVR106 | Active comparator | Biological: ALVR106ALVR106, visually identical to placebo |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Undergone hematopoietic cell transplantation (HCT) ≥21 days or solid organ transplantation (SOT) ≥28 days prior to study treatment administration
- Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
- Diagnosis of Upper or mild Lower Respiratory Tract Infection
Key exclusion criteria (3 listed)
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
- Infection by novel coronavirus disease 2019 (COVID-19)
- For HCT patients, evidence of Grade >2 GVHD; and for SOT patients, any history or evidence of GVHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALVR106Infusion, visually identical to placebo | Biological | ALVR106 |
| PlaceboInfusion, visually identical to ALVR106 | Biological | Placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Time frame: Day 1 up to 12 months
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.
Change in Viral Load From Baseline to Day 28 (Part B)
Time frame: Baseline and Day 28 (Part B)
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
4 secondary outcomes
Identify the Recommended Phase 2 Dose (RP2D) (Part A)
Time frame: Day 1 up to 12 months
Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31004020Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
- Derived from this study: PubMed 37323051Papayanni PG, Koukoulias K, Kuvalekar M, Watanabe A, Velazquez Y, Ramos CA, Leen AM, Vasileiou S. T cell immune profiling of respiratory syncytial virus for the development of a targeted immunotherapy. Br J Haematol. 2023 Aug;202(4):874-878. doi: 10.1111/bjh.18933. Epub 2023 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALVR106 in people with Respiratory Tract Viral Infections and Human Metapneumovirus (hMPV) Infection, run by AlloVir at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) (time frame: Day 1 up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04933968, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.