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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)

Must not have

Requirement for FiO2 > 50% oxygen to maintain oxygen saturation > 90% (peripheral pulse-ox).

Uncontrolled relapse of malignancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days following the last treatment of mvst

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

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

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I need a lot of oxygen to keep my blood oxygen level normal.

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My cancer has returned and is not under control.

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I do not have any uncontrolled infections.

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

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

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

Primary study objectives

Treatment related adverse events.

Secondary study objectives

Antiviral Response.

Number of patients with acute GvHD.

Number of patients with secondary graft failure.

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: 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 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER

285 Previous Clinical Trials

81,639 Total Patients Enrolled

Baylor College of MedicineLead Sponsor

1,023 Previous Clinical Trials

6,029,234 Total Patients Enrolled

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.