Clinical trial · Interventional
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
NCT05305040CI-TRIAL-00077196PreventterminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study discontinued as DSMB determined it was futile. No safety concerns were noted.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenovirus Infection | — | UNRESOLVED | — |
| BK Virus Infection | — | UNRESOLVED | — |
| Cytomegalovirus Infections | — | UNRESOLVED | — |
| Epstein-Barr Virus Infections | — | UNRESOLVED | — |
| Human Herpes Virus-6 Infection | — | UNRESOLVED | — |
| JC Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Biological | — | UNRESOLVED |
| Posoleucel (ALVR105) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Posoleucel (ALVR105)
- description
- Administered as 2-4 milliliter infusion, visually identical to placebo
- interventionNames
- Biological: Posoleucel (ALVR105)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
- interventionNames
- Biological: Placebo
Primary outcomes (1)
- measure
- Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
- timeFrame
- Through Week 14
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Key Inclusion Criteria: * 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 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.
References
Publications (3)
- BACKGROUNDPosoleucel (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.
- BACKGROUNDTzannou 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. PMID 28783452
- DERIVEDVasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19. PMID 38597860