Study of ALVR106 in Patients With Respiratory Viral Infec... | NCT04933968

NCT04933968

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo, visually identical to ALVR106	Biological: Placebo
ALVR106	Active Comparator	ALVR106, visually identical to placebo	Biological: ALVR106

Name	Type	Description	Arm Group Labels	Other Names
ALVR106	Biological	Infusion, visually identical to placebo	ALVR106

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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	Baseline and Day 28 (Part B)

Secondary Outcomes

Measure	Description	Time Frame
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.	Day 1 up to 12 months
Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Scottsdale Healthcare Hospitals DBA HonorHealth		Scottsdale	Arizona	85260	United States
City of Hope

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31004020	Background	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.
37323051

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Placebo	Participants were randomized to receive placebo, and were administered placebo as an intravenous (IV) infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 19, 2022	Apr 8, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

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.

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.

Arm/Group Information

ID	Title	Description
BG000	Part A: Placebo	Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
BG001	Part A ALVR106 Cohort 1: Dose A	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
BG002	Part A ALVR106 Cohort 2: Dose B	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
BG003	Part A ALVR106 Cohort 3: Dose C	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
BG004	Part A ALVR106 Cohort 4: Dose D	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
≤ 18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0012 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG0001 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The safety population included all randomized participants who received any amount of ALVR106 or placebo.

Posted

Count of Participants

Participants

Day 1 up to 12 months

ID	Title	Description
OG000	Part A: Placebo	Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
OG001	Part A ALVR106 Cohort 1: Dose A	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.
OG002	Part A ALVR106 Cohort 2: Dose B	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.
OG003	Part A ALVR106 Cohort 3: Dose C	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.
OG004	Part A ALVR106 Cohort 4: Dose D	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.

Units	Counts
Participants	OG0002 OG0013 OG0024 OG003

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG0002 OG0013 OG0024 OG003

Primary

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

No participants were enrolled into Part B due to the early termination of the study.

Posted

Baseline and Day 28 (Part B)

ID	Title	Description
OG000	Part B Expansion Cohort	It was planned to enroll and randomize participants at high-risk with upper respiratory tract infections into Part B to receive placebo or ALVR106 at the RP2D. Due to the early termination of the study, no participants were enrolled into the Part B expansion cohort.

Units	Counts
Participants	OG000

Secondary

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.

All randomized participants who received ALVR106 in Part A.

Posted

Number

x 10^5 cells/kg

Day 1 up to 12 months

ID	Title	Description
OG000	All Doses ALVR106 (Part A)	Participants who were randomized to receive ALVR106 in Part A, including Doses A, B, C, and D.

Units	Counts
Participants	OG00014

Secondary

Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)

The modified intent-to-treat population included all randomized participants who received any amount of ALVR106 or placebo and had confirmed virologic infection of interest at baseline (detectable viral load). Participants with baseline and Day 28 available data are included.

Posted

Mean

Standard Deviation

cycles

Baseline and Day 28

ID	Title	Description
OG000	Part A: Placebo	Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.
OG001	Part A ALVR106 Cohort 1: Dose A

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)

No participants were enrolled into Part B due to the early termination of the study.

Posted

Day 1 up to 12 months

ID	Title	Description
OG000	Part B Expansion Cohort	It was planned to enroll and randomize participants at high-risk with upper respiratory tract infections into Part B to receive placebo or ALVR106 at the RP2D. Due to the early termination of the study, no participants were enrolled into the Part B expansion cohort.

Units	Counts
Participants	OG0000

Secondary

Percentage Reduction in Viral Load From Baseline to Month 6 (Part B)

No participants were enrolled into Part B due to the early termination of the study.

Posted

Day 1 and Month 6

ID	Title	Description
OG000	Part B Expansion Cohort	It was planned to enroll and randomize participants at high-risk with upper respiratory tract infections into Part B to receive placebo or ALVR106 at the RP2D. Due to the early termination of the study, no participants were enrolled into the Part B expansion cohort.

Units	Counts
Participants	OG0000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Placebo	Participants were randomized to receive placebo, and were administered placebo as an IV infusion on Day 1. Participants returned to the clinic for assessments up to Day 14, and based on assessments could receive a second infusion of placebo on Day 14. Participants were followed for up to 12 months.	0	2	0	2	2	2
EG001	Part A ALVR106 Cohort 1: Dose A	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.	0	3	2	3	3	3
EG002	Part A ALVR106 Cohort 2: Dose B	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose B as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose B on Day 14. Participants were followed for up to 12 months.	2	4	3	4	4	4
EG003	Part A ALVR106 Cohort 3: Dose C	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose C as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose C on Day 14. Participants were followed for up to 12 months.	2	4	3	4	4	4
EG004	Part A ALVR106 Cohort 4: Dose D	Participants were randomized to receive ALVR106, and were administered ALVR106 Dose D as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose D on Day 14. Participants were followed for up to 12 months.	0	3	1	3	3	3

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG0030 affected4 at risk EG0040 affected3 at risk
COVID-19	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0022 affected4 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Liver function test increased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Viral haemorrhagic cystitis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Septic shock	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Pyrexia	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA Version 25.1	Systematic Assessment	EG0002 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected3 at risk EG0023 affected4 at risk EG0030 affected4 at risk EG0040 affected3 at risk
Sepsis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
BK virus infection	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Influenza	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Oral herpes	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Otitis media	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0021 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hyperaesthesia teeth	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Pyrexia	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Fatigue	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Chills	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Influenza like illness	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Oedema peripheral	General disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
White blood cell count decreased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0022 affected4 at risk EG003
Neutrophil count decreased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0022 affected4 at risk EG003
Platelet count decreased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Blood bilirubin increased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Blood creatinine increased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Transfer factor reduced	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Vitamin D decreased	Investigations	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0021 affected4 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Acute graft versus host disease in skin	Immune system disorders	MedDRA Version 25.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Chronic graft versus host disease in lung	Immune system disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Chronic graft versus host disease oral	Immune system disorders	MedDRA Version 25.1	Systematic Assessment	EG0001 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Muscle tension dysphonia	Nervous system disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected3 at risk EG0020 affected4 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Hot flush	Vascular disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Superficial vein thrombosis	Vascular disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Hypogonadism	Endocrine disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Depression	Psychiatric disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Chimerism	Congenital, familial and genetic disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Dry eye	Eye disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0021 affected4 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003
Portal hypertension	Hepatobiliary disorders	MedDRA Version 25.1	Systematic Assessment	EG0000 affected2 at risk EG0010 affected3 at risk EG0020 affected4 at risk EG003

Results are included for Part A only as no participants were enrolled into Part B due to early study termination.

Certain Agreements

First MCP Posted Date

ID	Term
D007239	Infections
D018184	Paramyxoviridae Infections
D012141	Respiratory Tract Infections

Title

Denominators

Categories

Title	Measurements
	OG000NAThe MTD and RP2D could not be determined due to too few dose-limiting toxicities during the study prior to early study termination.

Participants were randomized to receive ALVR106, and were administered ALVR106 Dose A as an IV infusion on Day 1. Participants returned to the clinical site for assessments up to Day 14, and based on assessments could receive a second infusion of ALVR106 Dose A on Day 14. Participants were followed for up to 12 months.

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ID	Term
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases