Study to Evaluate Viralym-M (ALVR105) for the Treatment o... | NCT04390113

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)	Biological: Placebo
Posoleucel (ALVR105)	Experimental	Administered as 2-4 milliliter infusion, visually identical to placebo	Biological: Posoleucel (ALVR105)

Name	Type	Description	Arm Group Labels	Other Names
Posoleucel (ALVR105)	Biological	Administered as 2-4 milliliter infusion, visually identical to placebo	Posoleucel (ALVR105)

Measure	Description	Time Frame
Time to Resolution of Macroscopic Hematuria	Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.	Up to 24 weeks

Measure	Description	Time Frame
Time Until Bladder Pain is Resolved		Until event occurrence through Week 24
Days in the Hospital for Any Reason		Until event occurrence through Week 24
Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria

Participants must meet all of the following criteria in order to be eligible to participate in the study:

Male or female ≥1 year of age.
Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
Diagnosed with HC based on the following criteria (all 3 criteria must be met):
1. Clinical signs and/or symptoms of cystitis.
2. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
3. Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.

Key Exclusion Criteria

Participants who meet any of the following criteria will be excluded from participation in the study:

Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
Evidence of active Grade >2 acute graft versus host disease (GVHD).
Uncontrolled or progressive bacterial or fungal infections.
Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
Pregnant or lactating or planning to become pregnant.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010	United States
Children's Hospital of Los Angeles

PubMed Identifier	Type	Citation	Retractions
28783452	Background	Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
38597860

ID	Title	Description
FG000	Posoleucel (ALVR105)	All participants received 2 infusions of either posoleucel (PSL) or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered intravenously (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 23, 2022	Apr 18, 2024

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

Time to Resolution of Macroscopic Hematuria

Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.

BK Intent-to-Treat [ITT] Population: All patients randomized who had BKV in their urine at baseline.

Posted

Median

95% Confidence Interval

Days

Up to 24 weeks

ID	Title	Description
OG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
OG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Units	Counts
Participants	OG00048 OG00138

Title

Denominators

Categories

Title	Measurements
	OG00036(22.0 to 63.0) OG00131(18.0 to 63.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.6253		Hazard Ratio (HR)	0.92			2-Sided	95	0.55	1.55					Superiority

Secondary

Time Until Bladder Pain is Resolved

Data not collected due to early termination after Data and Safety Monitoring Board (DSMB) futility analysis concluded the study was unlikely to meet its primary endpoint.

Posted

Until event occurrence through Week 24

ID	Title	Description
OG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
OG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Secondary

Days in the Hospital for Any Reason

Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.

Posted

Until event occurrence through Week 24

ID	Title	Description
OG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
OG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Secondary

Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)

Grading of acute GVHD is reported according to CTCAE version 5.0 which ranges from Grade 0 (best/no disease) to Grade IV (worst). Participants with Grade I-IV are included.

Modified ITT Population (mITT): All randomized participants who receive any dose of study drug.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
OG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Secondary

Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)

CRS is defined as a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms can be progressive, must include fever at the onset, and may include hypotension, capillary leak (hypoxia), and end organ dysfunction.

mITT: All randomized participants who receive any dose of study drug.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
OG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Secondary

Time to Resolution for All Target Viruses

Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.

Posted

Until event occurrence through Week 24

ID	Title	Description
OG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
OG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Secondary

Average Daily Bladder Pain

Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.

Posted

Until event occurrence through Week 6

ID	Title	Description
OG000	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
OG001	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 affected57 at risk EG0011 affected39 at risk
Viral haemorrhagic cystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0012 affected39 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0010 affected39 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0011 affected39 at risk
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0010 affected39 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Bacterial sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Human herpesvirus 6 encephalitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Kidney infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Mastoiditis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Otitis media acute	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Post-acute COVID-19 syndrome	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0011 affected39 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0011 affected39 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0010 affected39 at risk
Anuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Dysuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Viral haemorrhagic cystitis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected39 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected39 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0010 affected39 at risk
Abdominal pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0011 affected39 at risk
Acute graft versus host disease in liver	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Chronic graft versus host disease in intestine	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Seizure	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Pericarditis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0012 affected39 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected39 at risk
Lipase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk
Arterial revascularisation	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected39 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0014 affected39 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0013 affected39 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0015 affected39 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0013 affected39 at risk
Oral candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0013 affected39 at risk
Epstein-Barr virus infection reactivation	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Viral haemorrhagic cystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00013 affected57 at risk EG0018 affected39 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00011 affected57 at risk EG0013 affected39 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0017 affected39 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0007 affected57 at risk EG0012 affected39 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0013 affected39 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected57 at risk EG0011 affected39 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0016 affected39 at risk
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0015 affected39 at risk
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0007 affected57 at risk EG0013 affected39 at risk
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0005 affected57 at risk EG0013 affected39 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0013 affected39 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0014 affected39 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0014 affected39 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0009 affected57 at risk EG0018 affected39 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0015 affected39 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Acute graft versus host disease in intestine	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0008 affected57 at risk EG0013 affected39 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0015 affected39 at risk
Chronic graft versus host disease in skin	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0013 affected39 at risk
Chronic graft versus host disease in intestine	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Chronic graft versus host disease in eye	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected39 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00011 affected57 at risk EG0018 affected39 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0014 affected39 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0012 affected39 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 affected57 at risk EG0012 affected39 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected57 at risk EG0011 affected39 at risk
Dysuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0012 affected39 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0013 affected39 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected57 at risk EG0019 affected39 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0010 affected39 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0017 affected39 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0006 affected57 at risk EG0014 affected39 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected57 at risk EG0011 affected39 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected39 at risk
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected39 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected39 at risk
Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected39 at risk
Dry eye	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected39 at risk
Acute myeloid leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0012 affected39 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0012 affected39 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected39 at risk
Acute graft versus host disease in liver	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Chronic graft versus host disease oral	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected39 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0012 affected39 at risk
Adenovirus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected39 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0012 affected39 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0012 affected39 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected39 at risk
Blood bilirubin increased	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0013 affected39 at risk
C-reactive protein increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0012 affected39 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected39 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected39 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0013 affected39 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected39 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0012 affected39 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0012 affected39 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0013 affected39 at risk
Hallucination	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected39 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected39 at risk
Agitation	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0012 affected39 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 affected57 at risk EG0012 affected39 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected57 at risk EG0010 affected39 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected57 at risk EG0010 affected39 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected57 at risk EG0012 affected39 at risk

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Title	Description
BG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
BG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Posoleucel (ALVR105)	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	2	57	28	57	54	57
EG001	Placebo	All participants received 2 infusions of either PSL or placebo separated by 14 (±3) days. Administering the second infusion as early as 11 days after the first infusion was encouraged if feasible. Participants who weighed <40 kg at the time of screening received 2×10^7 PSL cells (or placebo), while those who weighed ≥40 kg at the time of screening received 4×10^7 PSL cells (or placebo). All infusions were administered (IV) (via peripheral or central line) over approximately 5 minutes as a slow push.	1	40	19	39	36	39