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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

NATS Trial 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.Check my eligibility

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.See study design

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.

NATS Trial 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.

NATS Trial 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

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

Primary outcome measures

Incidence of acute GvHD (grade III-IV)

Incidence of adverse events as per CTCAE common criteria guidelines.

Secondary outcome measures

Antiviral Immunity

Antiviral response

NATS 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

210 Previous Clinical Trials

207,725 Total Patients Enrolled

Michael D Keller, MDPrincipal InvestigatorChildren's National Research Institute

Media Library

Virus Specific T cells (VSTs) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03180216 — Phase 1

Bone Marrow Transplant Infection Research Study Groups: Prophylactic and treatment

Bone Marrow Transplant Infection Clinical Trial 2023: Virus Specific T cells (VSTs) Highlights & Side Effects. Trial Name: NCT03180216 — Phase 1

Virus Specific T cells (VSTs) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03180216 — Phase 1

Frequently Asked Questions

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

Has the FDA granted permission for Virus Specific T cells (VSTs) to be used?

"The safety of Virus Specific T cells (VSTs) is rated a 1, as this first stage clinical trial has only limited evidence supporting its efficacy and security."

Answered by AI

Are there any opportunities for people to sign up and take part in this experiment?

"The information on clinicaltrials.gov reveals that this medical trial is not currently enlisting applicants. This study was initially posted February 15th, 2017 and has since been updated August 30th 2022. Unfortunately, the research team is closed to new participants at present; however, there are 832 other studies actively enrolling patients right now."

Answered by AI