This phase I/II clinical trial tests the safety and efficacy of haploidentical viral specific T-cells for the treatment of patients with cytomegalovirus (CMV) and/or adenovirus (ADV) that has not responded to previous treatment (refractory) after hematopoietic cell transplantation. CMV and ADV infections are common complications after hematopoietic cell transplantation. The current approach to treatment are anti-virals that can be either toxic, not entirely effective, or not available in a timely fashion. Also, patients who become refractory to anti-viral therapy have no other options and are at higher risk for mortality. Viral specific T-cells are cells that have been collected from a donor that specifically fight either the CMV or ADV virus by decreasing the viral load, or the amount of virus, in the patient's body. Treatment with these cells may be a safe and more effective way to treat refractory CMV or ADV infections after hematopoietic cell transplantation.
Additional locations may be listed on ClinicalTrials.gov for NCT05664126.
Locations matching your search criteria
United States
Tennessee
Memphis
Saint Jude Children's Research HospitalStatus: Active
Contact: Swati Naik
Phone: 901-595-3300
PRIMARY OBJECTIVES:
I. Determine the safety of viral specific T-cells (VSTs) used to treat CMV and/or ADV viremia post-hematopoietic cell transplantation (HCT). (Phase I)
II. 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. (Phase II)
SECONDARY OBJECTIVES:
I. Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion.
II. Assess the persistence of response for 6 months post-infusion.
EXPLORATORY OBJECTIVE:
I. To track the in vivo expansion and persistence of VSTs and their T-cell receptor (TCR) repertoire post-infusion.
OUTLINE: Patients are assigned to 1 of 2 cohorts. Patients who are to receive VSTs from the same donor who provided their stem cells (identical) are assigned to cohort A. Patients who are to receive VSTs from a donor who is different from the one who provided their stem cells (non-identical) are assigned to cohort B.
COHORT A: Identical donors undergo leukapheresis for manufacturing of VST product and blood sample collection on study. Patients receive VSTs intravenously (IV) on study. Patients also undergo blood sample collection on study.
COHORT B: Non-identical donors undergo leukapheresis for manufacturing of VST product and blood sample collection on study. Patients receive VSTs IV on study. Patients also undergo blood sample collection on study.
After VST infusion, patients are followed up at 2 weeks, 4 weeks, 2 months, 3 months, and 6 months.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorSwati Naik
