← Back to Search

Virus Therapy

CMV-Specific T-Cell Therapy for CMV Infection Post-Transplant

Phase 1
Waitlist Available
Led By Arjang Djamali, MD, MS, FASN
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 55 weeks
Awards & highlights

Study Summary

This trial will test how well a person's body tolerates CMV-specific T cells. It will last 52 weeks +/- 3 weeks.

Who is the study for?
Adults aged 18-75 who've had a solid organ transplant and are experiencing CMV reactivation or infection despite antiviral treatment, or can't tolerate such treatments. They need an eligible donor for T-cell therapy, must not be on high-dose steroids or recent strong immunosuppressants, not have HIV, acute graft rejection, CMV retinitis, nor be pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial is testing the safety of using specific T-cells to fight Cytomegalovirus (CMV) in adults who received organ transplants. It's checking if these cells can help when standard antiviral drugs fail or cause side effects.See study design
What are the potential side effects?
Potential side effects may include immune reactions as the body adjusts to the new T-cells. Specific risks aren't detailed but could relate to how the immune system responds to these cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 55 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 55 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of GVHD Grade ≥1
Incidence of acute infusion-related toxicity
Incidence of de novo Antibodies against Organ Allograft Donor (dnDSA) after T-cell Transfer
+4 more
Secondary outcome measures
Efficacy: Number of participants having CMV reactivation
Efficacy: Overall Survival of Participant
Efficacy: Percentage of patients with ≥1 log decrease in CMV viral load
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tier 1Experimental Treatment1 Intervention
3 participants enrolled at dose level 5x10^3 cells/kg of CMV viral specific T-cells

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,589 Total Patients Enrolled
Arjang Djamali, MD, MS, FASNPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
10 Total Patients Enrolled
Sandesh Parajuli, MBBSPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

CMV specific T-cells (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03950414 — Phase 1
Cytomegalovirus Research Study Groups: Tier 1
Cytomegalovirus Clinical Trial 2023: CMV specific T-cells Highlights & Side Effects. Trial Name: NCT03950414 — Phase 1
CMV specific T-cells (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03950414 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research embrace individuals younger than 35 years of age?

"In order to meet the criteria for this trial, potential participants need to be aged 18 or above and 75 or below."

Answered by AI

Could I potentially become a participant in this clinical study?

"The enrolment requirements of this medical research involves having a cytomegalovirus infection and being between 18 to 75 years old. In total, 20 patients will be accepted into the study."

Answered by AI

Is this research experiment currently enrolling participants?

"The clinical trial is currently open to new participants according to details provided on clinicaltrials.gov. This study was initially added to the database on September 27th 2019, with the latest update being November 14th 2022."

Answered by AI

Has the federal agency sanctioned CMV specific T-cells for medicinal use?

"The safety of CMV specific T-cells is rated as a 1 due to the limited clinical data available at this Phase 1 stage."

Answered by AI

What outcomes is this research endeavor attempting to reach?

"This trial will assess safety and tolerability of acute GVHD over a three-week period from T-cell transfer to 4 hours post injection. Additionally, the feasibility of producing CMV virus specific T lymphocytes (VST) from donors as well as time taken for patient inclusion to administration of CMV-VST will be tracked. Lastly, efficacy evaluation in part shall consider the number of participants with cleared CMV infection (negative PCR or <250 copies/mL)."

Answered by AI

How many participants are actively engaged in this research?

"That is correct. According to the information on clinicaltrials.gov, this trial began recruiting candidates on September 27th 2019 and has most recently been updated November 14th 2022. It will be enrolling 20 patients from a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
2019. "A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03950414.
~0 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top