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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05305040




Registration number
NCT05305040
Ethics application status
Date submitted
22/03/2022
Date registered
31/03/2022
Date last updated
16/05/2024

Titles & IDs
Public title
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Scientific title
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
Secondary ID [1] 0 0
P-105-202 Phase 3
Universal Trial Number (UTN)
Trial acronym
Prevent
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenovirus Infection 0 0
BK Virus Infection 0 0
Cytomegalovirus Infections 0 0
Epstein-Barr Virus Infections 0 0
Human Herpes Virus-6 Infection 0 0
JC Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Posoleucel (ALVR105)
Treatment: Other - Placebo

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

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


Treatment: Other: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo

Treatment: Other: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
Timepoint [1] 0 0
Through Week 14
Secondary outcome [1] 0 0
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26
Timepoint [1] 0 0
Through Week 26
Secondary outcome [2] 0 0
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus
Timepoint [2] 0 0
Through Week 14

Eligibility
Key inclusion criteria
Key

* Any age at the day of screening visit.
* No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
* Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing
* Meet one or more of the following criteria at the time of randomization:

* Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
* Haploidentical donor
* Matched or Mismatched unrelated donor
* Use of umbilical cord blood as stem cell source
* Ex vivo graft manipulation resulting in T cell depletion
* Received anti-thymocyte globulin or alemtuzumab (Campath-1H)

Key
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
* Evidence of active Grade >2 acute GVHD
* Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
* Known history or current (suspected) diagnosis of Grade =3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >1.0 mg/kg/day) within 24 hours prior to dosing
* Relapse of primary malignancy other than minimal residual disease

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/01/2024
Sample size
Target
Accrual to date
Final
451
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New Jersey
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New York
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Washington
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Brugge
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Bruxelles
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Leuven
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Calgary
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Montréal
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Toronto
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Vancouver
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Lille
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France
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Nantes
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France
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Paris
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France
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Pierre-Bénite
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France
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Toulouse
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Firenze
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Milan
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Italy
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Pavia
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Italy
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Roma
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Italy
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Rome
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Italy
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Rozzano
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Italy
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Verona
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Korea, Republic of
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Busan
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Hwasun
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Adana
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Ankara
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Antalya
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Izmir
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Kocaeli
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Malatya
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Bristol
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Cambridge
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Glasgow
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AlloVir
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05305040
Trial related presentations / publications
Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05305040