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CompletedNCT01535885ACEUpdated Oct 25, 2021

Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV

A Phase 1 interventional study of Cytotoxic T Lymphocytes in Epstein-Barr Virus Infections, Adenovirus and Cytomegalovirus Infections, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged Up to 22 Years. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by Medical College of Wisconsin · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
Up to 22 Years
Sex
All
01

Study summary

This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.

Read the detailed description

Within this clinical trial, the investigators will test the hypotheses that the administration of CTLs for prophylaxis against Ad, CMV and EBV in recipients of TCD-HPCT will be safe and well tolerated. Graded doses of Multi-Virus CTL will be administered to recipients of genotypically haploidentical or mismatched unrelated TCD grafts.

02

Conditions studied

  • Epstein-Barr Virus Infections
  • Adenovirus
  • Cytomegalovirus Infections

Keywords

  • Cytoxic T Lymphocytes(CTL)
  • T-cell Depleted
  • Allogeneic Transplant
  • Epstein Barr Virus
  • Adenovirus
  • Cytomegalovirus
  • Hematopoietic progenitor cell transplantation
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 25 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient age \< 22 years.
  • Both genders and all races are eligible.
  • The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled.
  • Must be willing to sign a written informed consent.

  • Patient Organ Status at the time of enrollment (pre-transplant)

    • Lansky or Karnofsky score > 50
    • Echocardiogram shortening fraction > 27%
    • Renal function: serum creatinine \< 2 x normal for age
    • DLCO > 50% predicted in patients old enough to comply with PFTs or no baseline oxygen requirement for younger patients.
    • Hepatic: AST, ALT \< 5x upper limit of normal; bilirubin \< 2.0 mg/dl
  • Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months following CTL infusion. The male partner should use a condom.
  • Patients must be between 28 and 100 days post T-cell depleted allogeneic HPCT

  • Patients must meet the following criteria (within 72 hours of CTL infusion):

    • Achieved primary engraftment with an ANC of at least 1000 per μl for 3 consecutive days.
    • No oxygen requirement with oxygen saturations > 90%.
    • AST, ALT \< 5x upper limit of normal for age; bilirubin \< 2 mg/dl.
    • Hemoglobin > 8 gm/dl prior to infusion. (May be transfusion dependent).
    • Renal function: serum creatinine \< 2 x normal for age.

  • The Patient must not have the following conditions on the day of CTL infusion:

    • Exhibit overt hematologic manifestations of relapse or persistent disease.
    • Evidence of recurrent/persistent disease based primarily on flow cytometry, cytogenetics, chimerism analysis, or other molecular studies does not by itself represent grounds for exclusion.

Exclusion criteria

Exclusion Criteria:

  • Currently enrolled on another Phase I clinical trial.
  • Pregnant or nursing
  • Overt hematologic manifestations of relapse or persistent disease
  • Having > grade 1 graft-versus-host disease.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Multi-Virus CTLs

    The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study.

    Biological: Cytotoxic T Lymphocytes

Interventions

  • BiologicalCytotoxic T Lymphocytes

    Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used.

06

What researchers measure

Primary outcomes

  1. To assess toxicity by SAEs scored according to the adaptive CTCAE version 5

    Phase/safety/toxicity

    Time frame: 1 year

Secondary outcomes

  1. Evidence of immunity against specific viral pathogens- Ad, CMV and EBV in recipients of Multi-Virus CTLs

    Immunity will be recorded.

    Time frame: 1 year

  2. The incidence of Ad, EBV, and CMV systemic infections during the first 180 days post-transplant

    Number of infections will be quantified.

    Time frame: 1 year

07

Study locations

1 site
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01535885
Lead sponsor
Medical College of Wisconsin
Responsible party
Julie-An M. Talano (Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research, Medical College of Wisconsin) — Principal investigator
First posted
Feb 20, 2012
Start date
Feb 2012
Primary completion
Oct 2019
Completion
Oct 2019
Last update
Oct 25, 2021

Study contacts

Julie-An Talano, MD
principal investigator · Medical College of Wisconsin/Children's Hospital of Wisconsin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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