Cytomegalovirus Infections Clinical Trial
— PreventOfficial title:
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
Verified date | May 2024 |
Source | AlloVir |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 19, 2023 |
Est. primary completion date | January 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility | Key Inclusion Criteria - =1 year of age at the day of screening visit. - Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening - Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment - 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 - Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR - Use of umbilical cord blood as stem cell source - Ex vivo graft manipulation resulting in T cell depletion - Lymphocyte Count <180/mm3 and/or cluster of differentiation 4 (CD4) Count <50/mm3 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 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies - Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Johns Hopkins Hospital | Baltimore | Maryland |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | University of Virginia | Charlottesville | Virginia |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Children's Medical Center Dallas | Dallas | Texas |
United States | City of Hope National Medical Center | Duarte | California |
United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | Children's Mercy Kansas City | Kansas City | Missouri |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Weill Cornell Medical College | New York | New York |
United States | Childrens National Medical Center | Northwest Rectangle | District of Columbia |
United States | University of California, San Francisco Medical Center | San Francisco | California |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Stony Brook University Hospital Cancer Center | Stony Brook | New York |
United States | University of Kansas Hospital | Westwood | Kansas |
Lead Sponsor | Collaborator |
---|---|
AlloVir |
United States,
Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12. No abstract available. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease | 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 | Through Week 14 | |
Secondary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease | 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. | Through Week 26 | |
Secondary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV) | 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). | Through Week 26 | |
Secondary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV | 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). | Through Week 26 | |
Secondary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV) | 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). | Through Week 26 | |
Secondary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV) | 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). | through Week 26 | |
Secondary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6) | 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). | Through Week 26 | |
Secondary | Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV) | 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). | Through Week 26 | |
Secondary | Rates of Overall and Non-Relapse Mortality | The number of mortality events due to non-relapse causes through Week 52. | Through Week 52 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03950414 -
A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
|
Phase 1 | |
Recruiting |
NCT04690933 -
AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
|
||
Withdrawn |
NCT04936971 -
Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response
|
Phase 4 | |
Recruiting |
NCT02671318 -
Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence
|
Phase 4 | |
Completed |
NCT01325636 -
Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
|
Phase 1/Phase 2 | |
Recruiting |
NCT00228202 -
Genotyping of Cytomegalovirus From Patients in Israel
|
N/A | |
Completed |
NCT00031421 -
Neonatal CMV-Ganciclovir Follow-up Study
|
N/A | |
Completed |
NCT00005496 -
Inflammation, Infection, and Future Cardiovascular Risk
|
N/A | |
Terminated |
NCT03262194 -
Relevance of Gastric Aspirate in HCMV Detection
|
||
Completed |
NCT04478474 -
Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients
|
||
Recruiting |
NCT05370976 -
Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation.
|
Phase 2 | |
Active, not recruiting |
NCT02943057 -
Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis
|
Phase 4 | |
Completed |
NCT02538172 -
Cell-mediated Immunity for Prevention of CMV Disease
|
N/A | |
Completed |
NCT02642822 -
The Epidemiologic Study of Human Cytomegalovirus(CMV) in Female Students of Xiamen University
|
N/A | |
Completed |
NCT02134184 -
The Influence of Chronic CMV Infection on Influenza Vaccine Responses
|
Phase 4 | |
Completed |
NCT00673868 -
Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
|
Phase 1 | |
Active, not recruiting |
NCT05089630 -
A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06058858 -
Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
|
||
Active, not recruiting |
NCT04904614 -
Letermovir Use in Heart Transplant Recipients
|
Phase 4 | |
Completed |
NCT01986010 -
Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)
|
Phase 1 |