Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Herpes Simplex

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Cytomegalovirus Infections

Adenoviridae Infections

Disease Attributes

DNA Virus Infections

Herpesviridae Infections

Tumor Virus Infections

Cytomegalic Inclusion Disease

Administered as 2-4 milliliter infusion, visually identical to placebo

Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Posoleucel (ALVR105)

Placebo

This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.

There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.

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

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).

The number of clinically significant infections or episodes of end-organ disease per participant due to AdV, BKV, CMV, EBV, HHV-6, or JCV.

The number of participants with clinically significant infections or episodes of end-organ disease due to each of the following viruses: AdV, BKV, CMV, EBV, HHV-6, or JCV.

AlloVir

Adverse events are reported for the Safety Population which included all participants who received at least one dose of posoleucel or placebo.

Participants received posoleucel administered as 2-4 mL IV infusion once every 14 days for 7 doses.

Participants received placebo administered as a 2-4 mL IV infusion once every 14 days for 7 doses.

Participants received placebo administered as 2-4 mL IV infusion once every 14 days for 7 doses.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaskan Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Unknown

Race/Ethnicity, Customized

Safety Population: included all participants who received at least one dose of posoleucel or placebo.

The Sponsor decided to discontinue the Phase 3 part of the trial on 22 Dec 2023 following a pre-planned DSMB futility analysis concluding the study was unlikely to meet its primary endpoint; no safety concerns were identified. Data was not collected for efficacy analyses at Week 26 as planned. Participants were monitored through Week 26 for safety analyses.

Kevin Anderson

Includes modified Intent-to-Treat (mITT) Population comprised of all randomized participants who received study drug and completed through Week 14 visit.

Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14

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

Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26

HHV-6

Includes mITT Population comprised of all randomized participants who received study drug and completed through Week 14 visit.

Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus

Participants received posoleucel administered as 2-4 mL intravenous (IV) infusion once every 14 days for 7 doses.

Overall Study

This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.

There are 2 parts to the study, an open label Phase 2 cohort described in this posting, and a randomized, placebo controlled Phase 3 cohort described in NCT05305040. In the Phase 2 part, 25 to 35 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 week follow-up period.

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

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

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

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.

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).

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 14 and Week 26 (6 endpoints each at Week 14 and Week 26).

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

Posoleucel (ALVR105): Administered as 2-4 milliliter infusion

Age, Categorical

Race (NIH/OMB)

United States

Region of Enrollment

Underlying Disease

Type of Transplant

Analysis Population will include all patients who received posoleucel.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant	NCT05305040	Adenovirus Infe... BK Virus Infect... Cytomegalovirus... Epstein-Barr Vi... Human Herpes Vi... JC Virus Infect...	Posoleucel (ALV... Placebo	-	AlloVir
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant	NCT05305040	Adenovirus Infe... BK Virus Infect... Cytomegalovirus... Epstein-Barr Vi... Human Herpes Vi... JC Virus Infect...	Posoleucel (ALV... Placebo	-	AlloVir
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant	NCT04693637	Adenovirus Infe... BK Virus Infect... Cytomegalovirus... Epstein-Barr Vi... Human Herpes Vi... JC Virus Infect...	Posoleucel (ALV...	1 Year -	AlloVir

Spots Global Cancer Trial Database for posoleucel (alvr105)