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Virus Therapy

Specific T-Lymphocytes for Viral Infections (Gamma Capture Trial)

Phase 1 & 2

Waitlist Available

Led By Paul Szabolcs, MD

Research Sponsored by Paul Szabolcs

Eligibility Criteria Checklist

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

Must have

Diagnosis of Adenovirus, CMV, or EBV infection, persistent despite standard therapy.

- Refractory adenoviremia: defined as DNAemia >5000 copies/mL or <1 log decrease after at least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents) OR

Must not have

Females of child bearing potential must not be lactating.

Active acute GVHD grades II-IV.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first cellular infusion to 1 year post first cellular infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate if donor-derived T cells can help restore anti-viral immunity in transplant and immunocompromised patients who have adenovirus, CMV, or EBV infections.

Who is the study for?

This trial is for people aged 1 month to 65 years who've had a bone marrow or organ transplant, have compromised immunity, and are battling persistent infections from adenovirus, CMV, or EBV despite standard treatments. They must not be pregnant or breastfeeding and should agree to use birth control if applicable.

What is being tested?

The study tests the effectiveness of T-cells treated with gamma capture technology against viral infections in patients with weakened immune systems due to transplants or other conditions. It's a phase I/II trial assessing safety and how well these cells fight off specific viruses.

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions related to immune cell infusions such as fever, chills, fatigue, headache, nausea, vomiting, rash or potential worsening of infection symptoms.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My adenovirus levels are high despite 2 weeks of antiviral treatment.

Select...

I have an active CMV infection that hasn't improved after 14 days of treatment.

Select...

My lymphoma or posttransplant disease is EBV positive.

Select...

My CMV infection did not improve after 2 weeks of treatment.

Select...

I have a CMV infection or disease.

Select...

I have an adenovirus infection.

Select...

I cannot tolerate or am not allowed to take antiviral medications.

Select...

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

Select...

I have an ongoing adenovirus infection despite 2 weeks of treatment.

Exclusion Criteria

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

Select...

I am not breastfeeding.

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first cellular infusion to 1 year post first cellular infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first cellular infusion to 1 year post first cellular infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and first cellular infusion to 1 year post first cellular infusion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical response to treatment of viral infection

Grade III-IV Acute GvHD

Secondary study objectives

1-year overall survival from first cellular infusion (continuous)

Immune reconstitution with focus on adaptive T cell immunity and viral-specific responses

Incidence of Graft rejection

+3 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 Treatment1 Intervention

Viral Specific T-Lymphocytes 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 / 13Eligibility criteria met