Clinical Trials Logo

Clinical Trial Summary

The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection. Primary objective To determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and/or ADV viral load in the peripheral blood 4 weeks after VST infusion. When the initial viral load is <1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection. Secondary objectives - Determine the safety of VSTs when used to treat CMV and/or ADV viremia post-HCT. - Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion. - Assess the persistence of response for 6 months post-infusion.


Clinical Trial Description

The study will have 2 cohorts. Cohort A will include haploidentical donor who is identical to the stem cell donor. Cohort B will include haploidentical donor who is different from the stem cell donor. Seropositive donors will be screened for the presence of CMV- and ADV-specific T-cells using a functional flow cytometry assay. The donor will be considered suitable if the percentage of CD3+/IFN-γ+ cells is greater than 0.01% of CD3+ T-cells. Donor leukocytes will be collected using the Spectra Optia system. CMV- and ADV-specific T-cells will be isolated from donor leukocytes by 'IFN-γ-capture' technology using the Prodigy device over a 24-36 hour period and infused. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05664126
Study type Interventional
Source St. Jude Children's Research Hospital
Contact Naik Swati, MD
Phone 866-278-5833
Email referralino@stjude.org
Status Recruiting
Phase Phase 2
Start date August 1, 2023
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Completed NCT01195571 - Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age Phase 1
Recruiting NCT01248598 - The Prevelance Rate of Human Cytomegalovirus (HCMV), Epstein-Barr Virus (EBV) and Human Herpes Virus (HHV-6) in a Saliva of the Patient With Periodantitis N/A
Active, not recruiting NCT05575492 - A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age Phase 1/Phase 2
Recruiting NCT03665675 - Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT Early Phase 1
Completed NCT00456664 - CMV Disease and IRIS in HIV-1 Infected Persons N/A
Completed NCT04840199 - A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes. Phase 2
Active, not recruiting NCT05397223 - A Study of Modified mRNA Vaccines in Healthy Adults Phase 1
Completed NCT02452229 - Review of Human Herpes Viruses in Burns N/A
Completed NCT01160081 - Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis N/A
Completed NCT00467532 - Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients N/A
Terminated NCT03127787 - Clinical Performance Evaluation of DxN CMV Assay
Completed NCT00366717 - Cytomegalovirus Reactivation in Cancer Patients Receiving Chemotherapy N/A
Completed NCT00815802 - Detection of Human Cytomegalovirus in the Saliva N/A
Completed NCT01646645 - Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Suspended NCT00668798 - Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms N/A
Completed NCT00214240 - The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease N/A
Completed NCT00330018 - Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT) Phase 3
Completed NCT02083042 - Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Kidney Transplant Recipients N/A
Completed NCT01895049 - Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria Phase 4
Completed NCT01162330 - The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment N/A