Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
NCT05179057 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2024-05-08
Summary
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
Conditions
- Adenovirus Infection
Interventions
- DRUG
-
Posoleucel
Administered as 2-4 milliliter infusion, visually identical to placebo
- DRUG
-
Administered as 2-4 milliliter infusion, visually identical to Posoleucel
Sponsors & Collaborators
-
AlloVir
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-26
- Primary Completion
- 2024-01-31
- Completion
- 2024-01-31
- FDA Drug
- Yes
Countries
- United States
- Canada
- Italy
- Spain
- Sweden
- United Kingdom
Study Locations
More Related Trials
-
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
NCT03665675 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
NCT03842696 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
GVAX vs. Placebo for MDS/AML After Allo HSCT
NCT01773395 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT
NCT01822093 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
NCT04014374 ·Status: RECRUITING
-
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
NCT03266627 ·Status: RECRUITING ·Phase: PHASE2
-
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
NCT01949129 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT
NCT04746209 ·Status: RECRUITING ·Phase: PHASE2
-
Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)
NCT00711035 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Virus-specific ImmunoTherapy Following Allogeneic Stem Cell Transplantation
NCT02702427 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Administration of Virus-Specific Cytotoxic T-Lymphocytes
NCT00590083 ·Status: COMPLETED ·Phase: PHASE1
-
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT
NCT00840853 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT
NCT05066958 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Alternate Donor Study of Pre-Emptive Cellular Therapy
NCT01220895 ·Status: COMPLETED ·Phase: PHASE2
-
CMV Specific T Cell Therapy After Allogeneic Stem Cell Transplantation.
NCT03067155 ·Status: COMPLETED ·Phase: PHASE2
-
Allogeneic Virus-Specific Cytotoxic T-Lymphocytes(CTL), Persistent/Recurrent Viral Infection Post-HSCT (EAP CHALLAH)
NCT01945619 ·Status: NO_LONGER_AVAILABLE
-
Allogeneic Virus-specific T Cell Lines (VSTs)
NCT02510417 ·Status: COMPLETED ·Phase: PHASE1
-
Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion
NCT05236764 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Risk-adapted Donor Lymphocyte Infusion After Allo-HSCT in Children With Hematologic Malignancy
NCT05009719 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation
NCT04628338 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT
NCT01772953 ·Status: COMPLETED ·Phase: PHASE2
-
Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza
NCT05170009 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Pharmacokinetics-based Mycophenolate Mofetil Dosing for GVHD Prevention
NCT01487577 ·Status: COMPLETED ·Phase: PHASE2
-
Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT
NCT05015426 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants
NCT00674648 ·Status: COMPLETED ·Phase: PHASE1