What side effects are associated with this type of intervention?

Common treatments for Cytomegalovirus (CMV) include antiviral drugs like ganciclovir, valganciclovir, foscarnet, and cidofovir, which can cause side effects such as bone marrow suppression, renal toxicity, electrolyte imbalances, and gastrointestinal disturbances. Immune-based treatments, such as viral specific T cell infusions, may lead to infusion-related reactions, graft-versus-host disease (GVHD), and cytokine release syndrome (CRS).

What prior FDA approvals exist?

FDA-approved treatments for Cytomegalovirus (CMV) include antiviral drugs such as ganciclovir, valganciclovir, foscarnet, and cidofovir. These medications inhibit viral DNA replication and are commonly used in immunocompromised patients, including those who have undergone organ transplants. Additionally, letermovir has been approved for CMV prophylaxis in hematopoietic stem cell transplant recipients. The use of viral specific T cells, which aims to reconstitute anti-viral immunity, represents an advanced therapeutic approach currently under investigation, potentially offering targeted and durable immune responses against CMV.

What other types of research exist?

Promising novel alternatives to Viral Specific T Cells for CMV patients include the use of antiviral drugs such as letermovir, which has been approved for CMV prophylaxis in hematopoietic cell transplant recipients. Additionally, maribavir, another antiviral agent, has shown efficacy in treating refractory CMV infections. These therapies offer new options for managing CMV in patients with compromised immunity.

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Virus Therapy

Virus-Specific T-Cell Therapy for Infections

Phase 1 & 2

Waitlist Available

Led By Jessie Barnum, MD

Research Sponsored by Jessie L. Alexander

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical status, at time of consent, amendable to tapering of steroids to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion

Male or female, 1 month through 60 years old, inclusive, at the time of informed consent

Must not have

Active acute GVHD grades II-IV

Active extensive chronic GVHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion, an average of 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests special immune cells designed to fight specific viruses in patients with weak immune systems or those who have had transplants. These patients have infections that don't respond to regular treatments. The donor immune cells help attack the viruses in their bodies. This approach has shown promise in enhancing immune responses to viruses like CMV and EBV.

Who is the study for?

This trial is for people aged 1 month to 60 years who have had a bone marrow or organ transplant, or have compromised immunity due to other conditions. They must be struggling with infections from adenovirus, CMV, or EBV despite standard treatments. Women of childbearing age need a negative pregnancy test.

What is being tested?

The study tests if special immune cells called viral specific T-lymphocytes can fight off persistent infections by adenovirus, CMV, and EBV in those with weakened immune systems from transplants or other causes.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions related to immune cell infusions such as fever, chills, fatigue, headache, nausea and potential worsening of the underlying infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can reduce my steroid use to less than 1 mg/kg/day before cell therapy.

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I am between 1 month and 60 years old.

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I have had a stem cell or organ transplant, have a primary immunodeficiency, or am on immunosuppressive therapy.

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I have a persistent Adenovirus, CMV, or EBV infection despite treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe graft-versus-host disease.

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I have ongoing severe chronic graft-versus-host disease.

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My cancer, other than certain lymphomas, is actively worsening without control.

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I do not have any infections that are not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CTCAE Grade 4/5 Adverse Events

Grade III-IV Acute Graft versus host disease

Secondary study objectives

6-month Survival (continuous)

Antiviral Agents

Clinical response to viral specific infusion

+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: Viral Specific T-LymphocytesExperimental Treatment2 Interventions

Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.

0 / 8Eligibility criteria met

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 drugs like ganciclovir, foscarnet, and cidofovir, which inhibit viral DNA synthesis to prevent CMV replication. These treatments are essential for managing CMV, especially in immunocompromised patients, but can be limited by drug resistance and toxicity. Adoptive T-cell therapy, such as the infusion of CMV-specific cytotoxic T lymphocytes (CTLs), offers a targeted approach by directly attacking CMV-infected cells. This method is particularly beneficial for patients unresponsive to standard antiviral treatments or experiencing recurrent infections, providing a potentially more effective and less toxic alternative.

Therapeutic strategies for cytomegalovirus infection in haematopoietic transplant recipients: a focused update.