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Virus Therapy

HLA-matched VSTs for Viral Infections Post Stem Cell Transplant (TETRAVI Trial)

Phase 1

Recruiting

Led By John Craddock, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Received CAR-T cells targeting an antigen expressed on normal virus specific T cells

Steroids less than or equal to 1.0 mg/kg/day methylprednisolone (or equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days following the last treatment of mvst

Awards & highlights

TETRAVI Trial Summary

This trial is for patients who have had a stem cell transplant and have developed a viral infection that is not responding to standard therapy. In this trial, the patient will receive white blood cells that have been specially trained to fight the viral infection.

Who is the study for?

This trial is for patients who've had a stem cell transplant or CAR-T therapy and are struggling with persistent viral infections like EBV, CMV, adenovirus, or BK virus despite standard treatments. They should have partially HLA-matched T cells available and be able to taper off steroids. Pregnant women must test negative.Check my eligibility

What is being tested?

The study tests the use of banked multivirus-specific T cells (VSTs) from donors to treat stubborn viral infections in patients post allogeneic hematopoietic stem cell transplant or CAR-T recipients. The VSTs are designed to fight specific viruses that cause severe complications when the immune system is weak.See study design

What are the potential side effects?

Potential side effects aren't detailed but may include typical reactions related to immune therapies such as infusion-related symptoms, possible graft-versus-host disease (GVHD), and other immune-mediated responses.

TETRAVI Trial Eligibility Criteria

Inclusion Criteria

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

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I have received CAR-T cell therapy targeting a virus-related antigen.

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I am taking 1.0 mg/kg/day or less of steroids.

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I have a BK virus infection that didn't improve with specific antiviral treatments.

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I am receiving treatment for JC virus infection.

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I can reduce my steroid use to 0.5 mg/kg/day or less.

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I have had a stem cell transplant from a donor.

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I am being treated for JC virus infection and there are no other treatment options for me.

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I've had a stem cell transplant or received CAR-T cell therapy.

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My available virus-specific T-cells are partially matched to my HLA type.

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I have adenovirus that didn't improve with standard treatment.

TETRAVI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days following the last treatment of mvst

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 days following the last treatment of mvst

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days following the last treatment of mvst for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Treatment related adverse events.

Secondary outcome measures

Antiviral Response.

Number of patients with acute GvHD.

Number of patients with secondary graft failure.

TETRAVI Trial Design

1Treatment groups

Experimental Treatment

Group I: HLA-matched VSTsExperimental Treatment1 Intervention

Partially HLA-matched VSTs will be thawed and given by intravenous injection. Patients will receive 2 x 107 partially HLA-matched VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused with agreement of the principal investigator, patient and/or guardian and the treatment team Additional doses may be from the same donor or a different donor based on available cell lines and patient/disease factors. Decision to switch to a different donor can be made by the principal investigator based on factors that include sequential treatment of different viral infections, concerns for immune escape of the targeted virus and/or availability of a better matched or otherwise superior VST line. Additional treatments will only be given following the agreement of the patient, treating physician, and investigator. This process can be repeated as needed.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER

272 Previous Clinical Trials

80,408 Total Patients Enrolled

2 Trials studying Viral Infections

25 Patients Enrolled for Viral Infections

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,165 Total Patients Enrolled

2 Trials studying Viral Infections

25 Patients Enrolled for Viral Infections

John Craddock, MD2.122 ReviewsPrincipal Investigator - Baylor College of Medicine

Baylor College of Medicine

2Patient Review

Although this doctor is personable, I felt that they were very slow in addressing my concerns. I often had to wait a week or longer for answers or solutions, even when I was in discomfort.

Media Library

HLA-matched VSTs (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04013802 — Phase 1

Viral Infections Research Study Groups: HLA-matched VSTs

Viral Infections Clinical Trial 2023: HLA-matched VSTs Highlights & Side Effects. Trial Name: NCT04013802 — Phase 1

HLA-matched VSTs (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04013802 — Phase 1

Frequently Asked Questions

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

Have HLA-matched VSTs been cleared by the FDA?

"Our researchers at Power assessed the safety of human leukocyte antigen-matched VSTs to be a score of 1. This is due to its Phase 1 categorization, which implies limited evidence for both efficacy and safety."

Answered by AI

Is enrollment still available for this medical trial?

"In accordance with the clinicaltrials.gov, this medical trial continues to seek participants since its initial posting on March 8th 2021 and most recent refreshment on November 3rd 2022."

Answered by AI

What is the estimated enrollment of participants into this research endeavor?

"Affirmative. According to clinicaltrials.gov, this investigation is presently searching for participants and has been since March 8th 2021. The latest update was on November 3rd 2022 and the study desires 47 people across two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.

John Craddock 2021. "TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04013802.

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