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Virus Therapy
CMV-Specific T-Cells for Cytomegalovirus Infections
Phase 1
Recruiting
Led By Inga Hofmann, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Known resistance to ganciclovir and/or foscarnet based on molecular testing.
Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
Study Summary
This trial will test the safety and feasibility of using CMV-specific T-cells to treat CMV infections in people who have had a stem cell transplant or who are immunocompromised.
Who is the study for?
This trial is for pediatric and adult patients who have had a stem cell transplant or are immunocompromised, with CMV infections not improving after standard antiviral treatment, or those who can't tolerate such treatments. Participants must be at least one month old, weigh over 7 lbs, and have a performance status above 30%. Pregnant women and individuals with severe graft-versus-host disease or on high-dose steroids cannot join.Check my eligibility
What is being tested?
The study tests the safety and feasibility of treating CMV infections using T-cells that target the virus. These cells come from donors matching certain criteria. The trial will follow participants for one year to see how well this approach works in both children and adults post-stem cell transplantation or in other compromised immune conditions.See study design
What are the potential side effects?
While prior studies suggest that transferring CMV-specific T-cells is safe, potential side effects may include reactions related to immune response like fever or chills, GVHD risk increase if donor cells react against host tissues, fatigue due to immune system activation, and possible infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is resistant to ganciclovir or foscarnet.
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I cannot take or have had bad reactions to certain antiviral medications.
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I have CMV with symptoms or a positive test result.
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My CMV symptoms got worse or didn't improve on antiviral treatment.
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I am at least 1 month old.
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I have a CMV infection with more than 500 copies/ml or symptoms.
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I have CMV infection due to a weak immune system or after a stem cell transplant.
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I can care for myself but may need occasional help.
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My immune cells react to a specific test for a virus before I donate blood components.
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My donor matches me in at least 3 out of 6 key genetic markers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST
Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer
Feasibility: Successful production of CMV-VST from donors
+6 moreSecondary outcome measures
Cytomegalovirus Infections
Efficacy: Number of Participants with CMV Clearance
Efficacy: Number of Participants with Reduction or Clearance of Clinical Symptoms
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Suspension of CMV-specific T-cells in 10 mL of 0.9% NaCl with 2% HSA. Single dose max. 25,000 T cells/kg body weight (BW) of the recipient delivered via IV bolus injection.
Find a Location
Who is running the clinical trial?
University of Wisconsin Carbone Cancer Center (UWCCC)UNKNOWN
2 Previous Clinical Trials
18 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,951 Total Patients Enrolled
Inga Hofmann, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received a donor lymphocyte infusion less than 28 days ago.My viral load hasn't decreased after 2 weeks of antiviral treatment.I have severe graft-versus-host disease.My condition is resistant to ganciclovir or foscarnet.I am over 18, can donate blood through a procedure, and have had CMV.My health severely limits my daily activities.I am not pregnant, breastfeeding, and willing to use birth control if of childbearing potential.I have been diagnosed with CMV retinitis.My first choice for T cell donation is the original donor, but I have alternatives if needed.I am taking steroids heavier than 1.0 mg/kg of my body weight.I am HIV positive.I had a stem cell transplant from a donor less than 28 days ago.I have been treated with specific immune system targeting drugs within the last 28 days.I cannot take or have had bad reactions to certain antiviral medications.I have CMV with symptoms or a positive test result.My CMV symptoms got worse or didn't improve on antiviral treatment.I am at least 1 month old.I received a stem cell transplant from a donor and it's been at least 28 days.I am a woman of childbearing age and not pregnant.I have a CMV infection with more than 500 copies/ml or symptoms.I have CMV infection due to a weak immune system or after a stem cell transplant.I can care for myself but may need occasional help.My immune cells react to a specific test for a virus before I donate blood components.My donor matches me in at least 3 out of 6 key genetic markers.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the expected results of this clinical experimentation?
"The main goal of this study, which will last up to 12 weeks from the CMV-VST infusion date, is evaluating the feasibility in terms of days elapsed between patient enrollment and administration. Secondary objectives include measuring efficacy through assessing numbers of reactivations after initial viral clearance until Week 52, time taken for CMV clearance (negative PCR) from Day 0 to first day with two negative results on a PCR test, and time needed for ≥1 log change in viral load expressed as number of days."
Answered by AI
How many participants are currently enrolled in this research program?
"Affirmative. The details available on clinicaltrials.gov demonstrate that this medical research project, which was first posted on February 6th 2020, is still looking for participants. Approximately 20 patients must be recruited from a single site."
Answered by AI
Is the utilization of CMV-specific T-cells permitted under current FDA regulations?
"Currently, the available clinical data suggests limited efficacy and safety of CMV-specific T-cells, thus it was rated a 1 on our scale."
Answered by AI
Is the trial currently in search of participants?
"Affirmative, the information hosted on clinicaltrials.gov demonstrates that this investigation is currently enrolling participants. Initially posted in February of 2020, the study was most recently updated October 11th 2022 and aims to recruit 20 patients from one site."
Answered by AI
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