RECRUITING

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

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Conditions

CytomegalovirusAdenovirus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

Quick Facts

Study Start:2023-08-01
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05664126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05.
  2. * Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.
  3. * Patients have no suspected or confirmed GVHD.
  4. * Availability of haploidentical donor for isolation of virus-specific T-cells.
  5. * Have not received a Donor Lymphocyte Infusion in the past 4 weeks.
  6. * Female patients of childbearing age must have a negative pregnancy test.
  7. * Subject, parent, or guardian are capable of giving signed informed consent.
  8. * Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%.
  9. * Patients must have a bilirubin less than or equal to 2.5mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.
  10. * Patients must have an estimated glomerular filtration rate (GFR) greater than 60mL/min/1.73m2.
  11. * Patients must be free of severe infection which upon determination of the principal investigator precludes therapy with VST.
  12. * Patients must have FVC \>50% predicted or if unable to perform pulmonary function testing must maintain pulse oximetry saturation \> 92% on room air.
  13. * Patients must have engrafted with an ANC \>500 cells/mm3 for 3 consecutive days.
  14. * Age ≥18 years.
  15. * At least single haplotype matched (≥3/6) family member.
  16. * Donor will be identical to the stem cell donor (Cohort A) or different from the stem cell donor (Cohort B).
  17. * HIV negative.
  18. * For females of childbearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND not lactating with intent to breastfeed.
  19. * Regarding donation eligibility, is identified as either having completed the process of donor eligibility determination as outlined in 21CFR 1271 and agency guidance or does not meet 21CFR 1271 eligibility requirements but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21CFR.
  20. * Identified recipient with CMV and/or ADV reactivation post-HCT.
  1. * Active GVHD.
  2. * Pregnancy.
  3. * Inability to provide consent.
  4. * Need for vasopressor or ventilatory support Patients receiving steroids \>0.5 mg/kg prednisone equivalent at the time of VST infusion
  5. * Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.
  6. * Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion.

Contacts and Locations

Study Contact

Naik Swati, MD
CONTACT
866-278-5833
referralino@stjude.org

Principal Investigator

Naik Swati, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Naik Swati, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cytomegalovirus
  • Adenovirus