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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 belowSelect...
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:Select...
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.
Select...
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
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
Find a Location
Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
221 Previous Clinical Trials
258,338 Total Patients Enrolled
Michael D Keller, MDPrincipal InvestigatorChildren's National Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe graft-versus-host disease.I haven't had cell therapy, except for transplant-related ones, in the last 28 days.I am able to reduce my steroid use to less than 0.5 mg/kg/day.I am able to perform most of my daily activities.I have a treatment involving immune cells ready for use.I (or my guardian) can understand and agree to the study's requirements.I have a virus infection that didn't improve after 2 weeks of standard treatment.I haven't received specific immune-suppressing drugs in the last 28 days.My bilirubin levels are very high.I had a stem cell transplant from a donor more than 5 days ago.I have received vaccines to protect against specific viral infections due to my risk.I have a virus that didn't get better after 2 weeks of standard treatment.I'm sorry, but the criterion "recipient" is incomplete and requires further details or context. Please provide me with additional information so I can accurately summarize it for you.My cancer is currently growing or spreading.My blood tests for liver and kidney function, and hemoglobin levels are within required limits.I am not pregnant or have confirmed it with a test.
Research Study Groups:
This trial has the following groups:- Group 1: Prophylactic and treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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