Table 1.
Ongoing clinical trials evaluating CMV therapeutics and laboratory assays
| Trial identifier no. | Sponsor | Product name | Trial description | Trial status | |
|---|---|---|---|---|---|
| Drugs | NCT03930615 | Merck Sharp & Dohme Corp | Letermovir | Phase 3 to evaluate duration of prophylaxis in HCT recipients | Recruiting |
| NCT03940586 | Merck Sharp & Dohme Corp | Letermovir | Phase 2 to evaluate prophylaxis in pediatric HCT recipients | Recruiting | |
| NCT03728426 | Dana Farber Cancer Center + Merck Sharp & Dohme Corp | Letermovir | Phase 2 to evaluate treatment of refractory or resistant CMV in HCT/SOT/other immune- compromised | Recruiting | |
| NCT03443869 | Merck Sharp & Dohme Corp | Letermovir | Phase 3 to evaluate prophylaxis for kidney transplant recipients | Recruiting | |
| NCT02927067 | Shire | Maribavir | Phase 3 as preemptive treatment for HCT recipients | Recruiting | |
| NCT02931539 | Shire | Maribavir | Phase 3 as treatment for refractory or resistant CMV in HCT/SOT recipients | Recruiting | |
| Vaccines | NCT02396134 | CMVPepVax | Phase 2 in R+ HCT recipients | Recruiting | |
| NCT01877655 | Astellas Pharma Global Development, Inc. and Vical | TransVax (ASP0113) | Phase 3 in R+ HCT recipients | Completed, results announced | |
| NCT02506933 | City of Hope Medical Center | Triplex (CMV-MVA) | Phase 2 in R+ HCT recipients | Active, not recruiting | |
| NCT03560752 | City of Hope Medical Center | Triplex (CMV-MVA) | Phase 2 in HCT donors | Recruiting | |
| NCT03354728 | City of Hope Medical Center | Triplex (CMV-MVA) | Phase 1/2 in pediatric R+ HCT recipients | Recruiting | |
| NCT03383055 | Masonic Cancer Center, University of Minnesota | Triplex (CMV-MVA) | Phase 1 in autologous HCT | Recruiting | |
| NCT03629080 | Hookipa Biotech | HB-101 | Phase 2 in R-D+ kidney transplant candidates | Recruiting | |
| Adoptive cytotoxic T cell therapy | NCT03266640 | New York Medical College | Donor-derived CMV-specific CTL | Phase 2 single arm in pediatric and young adult HCT recipients for treatment of refractory CMV | Recruiting |
| NCT00673868 | Milton S. Hershey Medical Center | Donor-derived CMV-specific CTL | Phase 1 pediatric and adult recipients of T cell depleted HCT as CMV prophylaxis | Completed no published | |
| NCT03004261 | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Donor-derived CMV-specific CTL | HCT recipients as CMV treatment | Recruiting | |
| NCT00880789 | Baylor College of Medicine | Cord blood-derived CMV + adenovirus CTL | HCT recipients as prophylaxis | Completed | |
| NCT02210078 | M.D. Anderson Cancer Center | Donor-derived CMV-specific CTL | Phase 2 in HCT recipients as CMV treatment | Recruiting | |
| NCT01945814 | Children’s Research Institute | Donor-derived CMV + EBV + adenovirus CTL | Phase 1 in HCT as prophylaxis or treatment | Recruiting | |
| NCT01923766 | Children’s Research Institute | Cord blood-derived CMV + EBV + adenovirus CTL | Phase 1 in HCT as prophylaxis or treatment | Active, not recruiting | |
| NCT02210065 | M.D. Anderson Cancer Center | Autologous CMV-specific CTL | Phase 2 in HCT as preemptive CMV treatment | Completed | |
| NCT03665675 | Ohio State University Comprehensive Cancer Center | Donor-derived CMV-specific CTL | Phase 1 as treatment in HCT and SOT | Recruiting | |
| NCT01646645 | Atara Biotherapeutics with Memorial Sloan Kettering Cancer Center | Donor-derived CMV specific CTL | Phase 2 as treatment in HCT | Recruiting | |
| NCT03594981 | Children’s Research Institute | Cord blood-derived multi-virus (CMV, EBV, BKV and adenovirus) | Phasel/2 in HCT as prophylaxis or treatment | Recruiting | |
| NCT01535885 | Medical College of Wisconsin | Donor-derived CMV + EBV + adenovirus CTL | Phase 1 in HCT as prophylaxis | Recruiting | |
| NCT02136797 | Atara Biotherapeutics with Memorial Sloan Kettering Cancer Center | Third party CMV-specific CTL | Phase 2 as treatment in HCT | Recruiting | |
| NCT02985775 | Peking University People’s Hospital | Donor-derived CMV-specific CTLs | Phase 1/2 as preemptive treatment in HCT | Recruiting | |
| NCT02510404 | Children’s Research Institute | Third party CMV + EBV + adenovirus CTL | Phase 1 in patients before HCT with active viral infection | Active, not recruiting | |
| NCT02510417 | Children’s Research Institute | Third party CMV + EBV + adenovirus CTL | Phase 1 as treatment in HCT | Recruiting | |
| NCT02108522 | ViraCyte | Third party multi virus (CMV + EBV + adenovirus, + JC virus + BKV + HHV6 | Phase 1 as treatment in HCT | Active, not recruiting | |
| NCT02532452 | Children’s Hospital Medical Center, Cincinnati | Third party multi virus (CMV, EBV, BKV and Adenovirus) | Phase 2 as treatment in immune-compromised including HCT | Recruiting | |
| NCT02048332 | Children’s Hospital Medical Center, Cincinnati | Donor derived multivirus (CMV, EBV, BKV and Adenovirus) | Phase 1/2 as treatment in HCT | Recruiting | |
| Immune-assays | NCT02382211 | Oxford Immunotec | T-SPOT | Kidney transplant recipients to assess CMI dynamics (prospective observational) | Completed |
| NCT02538172 | University of Lausanne Hospitals | T-Track CMV assay | RCT in SOT recipients for d/c of prophylaxis | Recruiting | |
| NCT02156479 | Lophius Biosciences GmbH | T-Track CMV assay | HCT recipients to assess CMI dynamics (prospective observational) | Completed | |
| NCT02784756 | University Health Network, Toronto | Quantiferon-CMV | Prospective interventional in SOT recipients for decision to give prophylaxis | Recruiting | |
| NCT03924219 | Vanderbilt University Medical Center + ViraCor Laboratories | ICS | Pediatric SOT recipients to assess infection risk (prospective observational) | Recruiting | |
| NCT01558037 | Northwestern University + ViraCor Laboratories | ICS | SOT recipients | Completed |
CMV cytomegalovirus, HCT hematopoietic cell transplant, SOTsolid organ transplant, R recipient CMV serostatus, D donor CMV serostatus, CTL cytotoxic T cells, EBV Epstein Barr virus, BKV BK virus, HHV6 human herpes virus 6, CMI cell-mediated immunity, ICS intracellular cytokine staining