Trial Outcomes & Findings for Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (NCT NCT04693637)

Last Updated: 2024-05-09

Results Overview

The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

26 participants

Primary outcome timeframe

Through Week 14

Results posted on

2024-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Posoleucel (ALVR105) Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Overall Study STARTED	26
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Posoleucel (ALVR105) Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Overall Study Death	4
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	59.5 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants
Underlying Disease Leukemia	17 Participants n=5 Participants
Underlying Disease Myelodysplasia/Myeloproliferative	3 Participants n=5 Participants
Underlying Disease Lymphoma	2 Participants n=5 Participants
Underlying Disease Sickle Cell Anemia	2 Participants n=5 Participants
Underlying Disease Other	2 Participants n=5 Participants
Type of Transplant Haploidentical	12 Participants n=5 Participants
Type of Transplant Mismatched Unrelated	9 Participants n=5 Participants
Type of Transplant Matched Unrelated	4 Participants n=5 Participants
Type of Transplant Umbilical Cord Blood	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Week 14

The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease	3 Participants

SECONDARY outcome

Timeframe: Through Week 26

The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 26.

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease	7 Participants

SECONDARY outcome

Timeframe: Through Week 26

The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)	1 Participants

SECONDARY outcome

Timeframe: Through Week 26

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV	0 Participants

SECONDARY outcome

Timeframe: Through Week 26

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV)	5 Participants

SECONDARY outcome

Timeframe: through Week 26

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV)	1 Participants

SECONDARY outcome

Timeframe: Through Week 26

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6)	0 Participants

SECONDARY outcome

Timeframe: Through Week 26

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV)	0 Participants

SECONDARY outcome

Timeframe: Through Week 52

The number of mortality events due to non-relapse causes through Week 52.

Outcome measures

Outcome measures
Measure	Posoleucel (ALVR105) n=26 Participants Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Rates of Overall and Non-Relapse Mortality Overall Mortality	4 Participants
Rates of Overall and Non-Relapse Mortality Non-Relapse Mortality	0 Participants

Adverse Events

Posoleucel (ALVR105)

Serious events: 19 serious events

Other events: 26 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Posoleucel (ALVR105) n=26 participants at risk Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Congenital, familial and genetic disorders Adrenoleukodystrophy	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Abdominal Pain	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Diarrhoea	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Pancreatitis Acute	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Pancreatitis Necrotising	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
General disorders Pyrexia	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Graft versus host disease in gastrointestinal tract	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Acute graft versus host disease in skin	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Chronic graft versus host disease in lung	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Hypersensitivity	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Sepsis	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Cytomegalovirus infection reactivation	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Adenovirus infection	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Bacteraemia	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Clostridium difficile colitis	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations COVID 19	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Enterocolitis bacterial	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Gastroenteritis	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Genital herpes simplex	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Klebsiella bacteraemia	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Pneumonia	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Staphylococcal sepsis	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Injury, poisoning and procedural complications Transplant Failure	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Metabolism and nutrition disorders Decreased appetite	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukemia recurrent	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post Transplant Lymphoproliferative disorder	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Nervous system disorders Seizure	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Psychiatric disorders Mental Disorder	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Psychiatric disorders Suicidal Ideation	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Renal and urinary disorders Acute Kidney injury	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Renal and urinary disorders Cystitis haemorrhagic	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Renal and urinary disorders Nephrotic syndrome	3.8% 1/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26

Other adverse events

Other adverse events
Measure	Posoleucel (ALVR105) n=26 participants at risk Posoleucel (ALVR105): Administered as 2-4 milliliter infusion
Blood and lymphatic system disorders Anaemia	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Diarrhoea	61.5% 16/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Abdominal Pain	23.1% 6/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Constipation	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Nausea	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Vomiting	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Abdominal Pain Lower	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Abdominal tenderness	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Gastrointestinal disorders Dry mouth	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
General disorders Chills	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
General disorders Fatigue	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
General disorders Oedema peripheral	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
General disorders Pain	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
General disorders Pyrexia	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
General disorders Catheter site pain	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Acute graft versus host disease in skin	38.5% 10/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Graft versus host disease in gastrointestinal tract	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Chronic graft versus host disease in skin	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Immune system disorders Chronic graft versus host disease oral	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Cytomegalovirus infection reactivation	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Cytomegalovirus viraemia	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Sepsis	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Urinary Tract infection	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations COVID-19	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Polyomavirus viraemia	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Infections and infestations Upper Respiratory tract infection	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Injury, poisoning and procedural complications Procedural Pain	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Injury, poisoning and procedural complications Transplant Failure	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Investigations Weight decreased	23.1% 6/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Investigations Platelet count decreased	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Investigations Blood creatinine increased	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Investigations Aspartate aminotransferase increased	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Investigations White blood cell count decreased	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Investigations Alanine aminotransferase increased	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Metabolism and nutrition disorders Decreased Appetite	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Metabolism and nutrition disorders Hyperglycaemia	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Metabolism and nutrition disorders Dehydration	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Musculoskeletal and connective tissue disorders Pain in extremity	23.1% 6/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Musculoskeletal and connective tissue disorders Back pain	19.2% 5/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Musculoskeletal and connective tissue disorders Myalgia	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Musculoskeletal and connective tissue disorders Muscular weakness	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Musculoskeletal and connective tissue disorders Pain in jaw	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Nervous system disorders Tremor	23.1% 6/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Nervous system disorders Dizziness	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Nervous system disorders Headache	15.4% 4/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Nervous system disorders Presyncope	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Psychiatric disorders Depression	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Psychiatric disorders Insomnia	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Renal and urinary disorders Acute Kidney injury	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Renal and urinary disorders Pollakiuria	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.1% 6/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Respiratory, thoracic and mediastinal disorders Cough	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Skin and subcutaneous tissue disorders Rash	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Skin and subcutaneous tissue disorders Erythema	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Skin and subcutaneous tissue disorders Pruritus	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Skin and subcutaneous tissue disorders Skin Lesion	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Vascular disorders Hypotension	11.5% 3/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Vascular disorders Hypertension	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Eye disorders Dry eye	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26
Eye disorders Photophobia	7.7% 2/26 • All-cause mortality was assessed up to week 52; serious and other (not including serious) adverse events were assessed for up to week 26

Additional Information

Michelle Matzko, MD, PhD

AlloVir, Inc

Phone: 617-433-2605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place