Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant
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| ClinicalTrials.gov Identifier: NCT04933968 |
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Recruitment Status :
Recruiting
First Posted : June 22, 2021
Last Update Posted : April 19, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Tract Viral Infections Human Metapneumovirus (hMPV) Infection Parainfluenza (PIV) Infection Respiratory Syncytial Viral (RSV) Infection Influenza Infection | Biological: ALVR106 Biological: Placebo | Phase 1 Phase 2 |
The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT 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 - Dose Escalation in Patients with Upper Respiratory Tract Infections (URTI) at High-Risk of Progression to Lower Respiratory Tract Infections (LRTI)
Part B - Recommended Phase 2 Dose (RP2D) cohort expansion in patients with URTIs at high-risk of progression to LRTIs
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 77 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Transplant |
| Actual Study Start Date : | March 21, 2022 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | June 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo, visually identical to ALVR106
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Biological: Placebo
Infusion, visually identical to ALVR106 |
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Active Comparator: ALVR106
ALVR106, visually identical to placebo
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Biological: ALVR106
Infusion, visually identical to placebo |
- Safety and Tolerability of ascending doses of ALVR106 assessed through Adverse Events and Clinical Laboratory tests [ Time Frame: Up to Day 365 ]Number (%) of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug and number (%) of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0)
- Change in viral load (Part B) [ Time Frame: Day 28 ]Change from Baseline in viral load as measured by quantitative PCR of nasal swab
- Change in viral load [ Time Frame: Up to Month 6 ]Change from Baseline in viral load as measured by quantitative PCR of nasal swab
- Progression from URTI to LRTI [ Time Frame: Day 10, Day 28 ]Proportion of patients with progression to LRTI
- Identify the recommended Phase 2 (RP2D) (Part A) [ Time Frame: Day 28 ]
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| Ages Eligible for Study: | 17 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Undergone allogeneic, autologous, or cord blood stem cell transplantation at least 21 days prior to randomization
- Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
- Diagnosis of Upper Respiratory Tract Infection
Exclusion Criteria:
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
- Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies within 28 days
- Proven or suspected infection by novel coronavirus disease 2019 (COVID-19) within 28 days
- Evidence of Grade >2 acute graft versus host disease (GVHD)
- Receipt of another investigational antiviral treatment within 28 days
- Donor lymphocyte infusion or other T cell therapies performed <21 days prior to randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04933968
| Contact: Amy Wheeler | 833.409.2281 | Clinicaltrials@allovir.com |
Show 20 study locations
| Responsible Party: | AlloVir |
| ClinicalTrials.gov Identifier: | NCT04933968 |
| Other Study ID Numbers: |
P-106-001 |
| First Posted: | June 22, 2021 Key Record Dates |
| Last Update Posted: | April 19, 2022 |
| Last Verified: | April 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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) |
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Infections Communicable Diseases Virus Diseases Paramyxoviridae Infections |
Disease Attributes Pathologic Processes Mononegavirales Infections RNA Virus Infections |