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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
No Placebo-Only Group
Summary
This trial tests a treatment using special immune cells to fight CMV in adult organ transplant patients with severe infections. The treatment boosts the patient's immune response by using T cells trained to attack the virus. This approach has shown promising results in patients who have undergone stem cell transplants.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 55 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 55 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cytomegalovirus (CMV) include antiviral medications such as ganciclovir, foscarnet, and cidofovir, which inhibit viral DNA replication. These treatments are crucial for managing CMV infections, especially in immunocompromised patients, as they help control viral load and prevent complications.
Viral-specific T cells, as studied in the trial, represent a targeted immune response that enhances the body's ability to fight CMV by specifically recognizing and attacking CMV-infected cells. This approach is particularly important for CMV patients because it offers a more precise and potentially effective treatment option, reducing the risk of drug resistance and side effects associated with broad-spectrum antivirals.
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,234 Previous Clinical Trials
3,200,289 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
Jacques Galipeau, MDStudy DirectorUniversity of Wisconsin, Madison
6 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Tier 1
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.