MedTrace Logo

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation

NCT03475212 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.

Conditions

  • Cytomegalovirus Infections
  • Adenovirus Infection
  • EBV Infection

Interventions

BIOLOGICAL

Virus Specific T-cell (VST) infusion

Patients will receive partially HLA-matched VSTs as a single infusion. Patients who have a partial response (\>1 log decrease in viral load without clearance) or no response and do not have treatment-related dose-limiting toxicities are eligible to receive up to 3 additional doses from day 30 after the initial infusion and at 2 weekly intervals thereafter. The viral load of the virus (or viruses) that patients are initially treated for are monitored by viral PCR.

Sponsors & Collaborators

  • Pediatric Transplantation & Cellular Therapy Consortium

    lead OTHER

Principal Investigators

  • Michael Pulsipher, MD · Children's Hospital Los Angeles

  • Michael Keller, MD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475212 on ClinicalTrials.gov