What side effects are associated with this type of intervention?

Common treatments for Cytomegalovirus (CMV) include antiviral medications such as ganciclovir, valganciclovir, foscarnet, and cidofovir. These treatments can have significant side effects. Ganciclovir and valganciclovir may cause bone marrow suppression, leading to neutropenia, anemia, and thrombocytopenia. Foscarnet can result in nephrotoxicity and electrolyte imbalances, while cidofovir is also associated with nephrotoxicity and requires concurrent probenecid and saline hydration to mitigate this risk. For viral-specific T cells, which are a targeted immune response against CMV, the side effects are generally related to immune reactions, such as cytokine release syndrome, and potential graft-versus-host disease in transplant recipients.

What prior FDA approvals exist?

FDA-approved treatments for Cytomegalovirus (CMV) primarily include antiviral medications such as ganciclovir, valganciclovir, foscarnet, and cidofovir. These drugs work by inhibiting viral DNA replication. While these treatments are effective in managing CMV infections, they are not specifically targeted immune responses like the viral-specific T cells being studied in the trial. The trial's approach, using viral-specific T cells, represents a more targeted immune response against CMV, which is different from the broad antiviral activity of the currently approved drugs.

What other types of research exist?

Promising novel alternatives to viral-specific T cells for CMV treatment in 2024 include: 1) Antiviral drugs such as letermovir, which has shown efficacy in preventing CMV infection in hematopoietic cell transplant recipients. 2) Adoptive transfer of CMV-specific T cells derived from healthy donors, which can provide targeted immune responses without the need for patient-specific cell preparation. 3) Monoclonal antibodies targeting CMV, which are being developed to neutralize the virus and prevent infection. These alternatives offer potential benefits in terms of efficacy and safety for CMV patients.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 55 weeks for reporting.

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 more

Secondary 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 more

Awards & 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

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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.