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CAR T-cell Therapy

VST Therapy for Post-Transplant Viral Infections (NATS Trial)

Phase 1

Waitlist Available

Led By Michael D Keller, MD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

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

Must have

Clinical status at infusion allows for tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent

Karnofsky/Lansky score of ≥ 50

Must not have

Evidence of acute GVHD grades II-IV

Received donor lymphocyte infusion or other cellular therapies (with the exception of allogeneic cells related to transplantation) within 28 days prior to VST infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors.

Who is the study for?

This trial is for patients who've had a bone marrow or stem cell transplant and are at risk of, or currently have, certain viral infections (like EBV, CMV) that haven't improved after standard treatment. They should be relatively stable with no severe GVHD, uncontrolled cancer relapse, or recent use of other investigational drugs.

What is being tested?

The trial tests Virus Specific T cells (VSTs) from donors to see if they're safe and can prevent or treat viral infections in people who received allogeneic hematopoietic stem cell transplants. It has two parts: one for prevention and another for active infection treatment.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response to infused T-cells such as fever, fatigue, headache, rash. There might also be risks associated with how the body tolerates these new cells.

Eligibility Criteria

Inclusion Criteria

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

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I am able to reduce my steroid use to less than 0.5 mg/kg/day.

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I am able to perform most of my daily activities.

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I have a treatment involving immune cells ready for use.

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I (or my guardian) can understand and agree to the study's requirements.

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My blood tests for liver and kidney function, and hemoglobin levels are within required limits.

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 haven't had cell therapy, except for transplant-related ones, in the last 28 days.

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I haven't received specific immune-suppressing drugs in the last 28 days.

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My bilirubin levels are very high.

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My cancer is currently growing or spreading.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of acute GvHD (grade III-IV)

Incidence of adverse events as per CTCAE common criteria guidelines.

Secondary study objectives

Antiviral Immunity

Antiviral response

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: Prophylactic and treatmentExperimental Treatment1 Intervention

Virus Specific T cells (VSTs) for prophylactic and treatment of active viral infection(s) after HSCT. 3 different dose levels starting with 1 x 10E7 /m2 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 2 x 10E7/m2 and a final dose 5 x 10E7 VSTs/m2

0 / 10Eligibility criteria met