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

NCT05664126 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: VSTHCTNCI-2023-03240
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cytomegalovirus; Adenovirus

Outcome Measures

Primary Outcomes (1)

• Degree of reduction of CMV and/or ADV viral load

  The primary objective of this clinical study is to evaluate the efficacy of adoptively transferred CMV- and ADV-specific haploidentical T-cells in patients who have undergone allogeneic HCT. This primary endpoint is defined as ≥1 log10 reduction in CMV and/or ADV viral load 4 weeks after VST infusion. When the initial viral load is \<1 log10 above the threshold of detection the endpoint will be a reduction to below the threshold of detection. The success rate will be evaluated using descriptive statistics (sample proportion and standard error). Patients with both CMV and ADC detected will count as success if reduction occurs in one or both of CMV and ADV.

  4 weeks after VST infusion

Secondary Outcomes (8)

• Incidence of infusion-related grade 3-5 adverse events 24 hours after infusion

  24 hours after infusion

• Incidence of AEs related to grade 3-4 cytokine release syndrome (CRS), or grade 1-2 CRS persist beyond 72 hours despite therapy

  4 weeks after VST infusion

• Incidence of Grade 3-4 Neurotoxicity of any duration

  4 weeks after VST infusion

• Incidence of Grade 3-4 GVHD

  4 weeks after VST infusion

• Incidence of grade 3-5 non hematologic toxicities attributable to VST

  4 weeks after VST infusion

Study Arms (2)

Cohort A

EXPERIMENTAL

Cohort A will include haploidentical donor who is identical to the stem cell donor. The first 5 patients will be enrolled in Cohort A. If safety criteria are met, cohort B will be open for enrollment.

Drug: VST infusion; Device: CliniMACS

Cohort B

EXPERIMENTAL

Cohort B will include haploidentical donor who is different from the stem cell donor

Drug: VST infusion; Device: CliniMACS

Interventions

VST infusion DRUG

single intravenous (IV) infusion.

Also known as: The product is a suspension of allogenic peripheral blood VSTs enriched based on their secretion of IFN-γ after stimulation with the appropriate antigen

Cohort A; Cohort B

CliniMACS DEVICE

Cells infusions are prepared using the ClinMACS

Also known as: ClinMACS Prodigy

Cohort A; Cohort B

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• Patients have no suspected or confirmed GVHD.
• Availability of haploidentical donor for isolation of virus-specific T-cells.
• Have not received a Donor Lymphocyte Infusion in the past 4 weeks.
• Female patients of childbearing age must have a negative pregnancy test.
• Subject, parent, or guardian are capable of giving signed informed consent.
• Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%.
• 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.
• Patients must have an estimated glomerular filtration rate (GFR) greater than 60mL/min/1.73m2 (may use estimated GFR that is auto calculated in the EHR).
• Patients must be free of severe infection which upon determination of the principal investigator precludes therapy with VST.
• Patients must have FVC \>50% predicted or able to maintain pulse oximetry saturation \> 92% on room air.
• Gut diarrhea \<1 liter/day (adults) or \<20mL/kg/day (children) or if unable to quantify, then occurrence of 4 stools per day above baseline.
• Patients must have engrafted with an ANC \>500 cells/mm3 for 3 consecutive days.
• Age ≥18 years.

You may not qualify if:

• Active GVHD.
• Pregnancy.
• Inability to provide consent.
• Need for vasopressor or ventilatory support Patients receiving steroids \>0.5 mg/kg prednisone equivalent at the time of VST infusion
• Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.
• Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion.
• Other severe uncontrolled concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St.Jude

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Naik Swati, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naik Swati, MD

CONTACT

866-278-5833; referralino@stjude.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations

US (1)