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Virus Therapy

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

Q: Is there an upper age limit to enrolling in this research endeavor?

In accordance with the eligibility requirements specified in this trial, participants must have attained at least one Month of age and not yet reached 65.

Q: Is this trial currently seeking participants?

Per the clinicaltrials.gov portal, this medical trial is not presently enrolling participants. The research was initially uploaded on October 1st 2023 and last edited on September 8th 2023; however, there are over 800 other studies actively seeking candidates at present.

Q: Am I eligible to take part in this trial?

To be included in this medical study, patients must have cytomegalovirus and fall within the age range of 1 Month to 65 Years old. The desired participant number for this trial is 25 individuals.

Q: What advances are investigators hoping to make with this research?

This 6-month medical study will assess the clinical response to viral infection treatment. The secondary objectives are to measure how often graft rejection occurs, if mechanical ventilation surpasses 48 hours, and if any concomitant antiviral medications were prescribed post-infusion.

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Gamma Capture Trial 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.Check my eligibility

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.See study design

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.

Gamma Capture Trial 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.

Gamma Capture Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical response to treatment of viral infection

Grade III-IV Acute GvHD

Secondary outcome measures

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

Gamma Capture 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 / 10Eligibility criteria met

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Who is running the clinical trial?

Paul SzabolcsLead Sponsor

7 Previous Clinical Trials

207 Total Patients Enrolled

Paul Szabolcs, MDPrincipal InvestigatorUniversity of Pittsburgh

7 Previous Clinical Trials

204 Total Patients Enrolled

Frequently Asked Questions

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

Is there an upper age limit to enrolling in this research endeavor?

"In accordance with the eligibility requirements specified in this trial, participants must have attained at least one Month of age and not yet reached 65."

Answered by AI

Is this trial currently seeking participants?

"Per the clinicaltrials.gov portal, this medical trial is not presently enrolling participants. The research was initially uploaded on October 1st 2023 and last edited on September 8th 2023; however, there are over 800 other studies actively seeking candidates at present."

Answered by AI

Am I eligible to take part in this trial?

"To be included in this medical study, patients must have cytomegalovirus and fall within the age range of 1 Month to 65 Years old. The desired participant number for this trial is 25 individuals."

Answered by AI

What advances are investigators hoping to make with this research?

"This 6-month medical study will assess the clinical response to viral infection treatment. The secondary objectives are to measure how often graft rejection occurs, if mechanical ventilation surpasses 48 hours, and if any concomitant antiviral medications were prescribed post-infusion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anti-viral T-cell Therapy by Gamma Capture

Paul Szabolcs 2024. "Anti-viral T-cell Therapy by Gamma Capture". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027879.

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