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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05664126
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adenovirus
  • Cytomegalovirus

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • VST infusion — DRUG
    single intravenous (IV) infusion.
  • CliniMACS — DEVICE
    Cells infusions are prepared using the ClinMACS

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    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.
  • Experimental: Cohort B
    Cohort B will include haploidentical donor who is different from the stem cell donor

Primary Outcome Measure

Degree of reduction of CMV and/or ADV viral load [ Time Frame: 4 weeks after VST infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St . Jude Children's Research HospitalMemphisTennessee38105
Naik Swati, MD
[email protected]
866-278-5833
Naik Swati, MD (PRINCIPAL_INVESTIGATOR)

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St . Jude Children's Research Hospital· Memphis, TN

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