← Back to Search

CAR T-cell Therapy

NST Therapy for Chronic Norovirus in Immunocompromised Patients (ATLANTIC Trial)

Phase 1

Recruiting

Led By Michael 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

Documentation of chronic norovirus infection: a. Chronic norovirus infections will be defined as having consecutive positive norovirus stool tests (2 or more) spanning a minimum three month period with attributable signs and symptoms of norovirus disease.

Be between 2 to 35 years of age (females) or 2 to 40 years of age (males)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 45 days of first nsts infusion

Awards & highlights

ATLANTIC Trial Summary

This trial will test a new therapy for people with a chronic norovirus infection who have either had a stem cell transplant or who have a primary immunodeficiency disorder.

Who is the study for?

This trial is for people aged 3 months to 80 years with chronic norovirus infection after a bone marrow transplant or those with primary immunodeficiency. They must have stable health indicators like specific blood counts and organ function tests, not be pregnant, and able to consent. Those who've had certain recent treatments or uncontrolled infections can't join.Check my eligibility

What is being tested?

The study is testing the safety of Norovirus-specific T-cell therapy in patients who either received a stem cell transplant or have an immune deficiency but haven't had a transplant. It's a Phase I trial where they gradually increase the dose to find out what's safe.See study design

What are the potential side effects?

Since this is an early-phase trial focused on safety, exact side effects aren't listed but may include typical reactions related to immune therapies such as fever, fatigue, allergic reactions, and potential worsening of underlying conditions.

ATLANTIC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had norovirus symptoms and positive tests for it over the last three months or more.

Select...

I am a female aged 2-35 or a male aged 2-40.

Select...

I have had a stem cell transplant for my blood condition.

Select...

I am of childbearing age and have a negative pregnancy test.

Select...

I do not have HTLV I/II.

Select...

I have had a stem cell transplant or have a primary immunodeficiency disorder.

Select...

After my stem cell transplant, my donor cells have remained stable in my body.

Select...

I can do most activities but may need help.

Select...

I am between 3 months and 80 years old.

Select...

My platelet count is at least 20,000, even if it required a transfusion.

Select...

I have Hepatitis C.

Select...

I am not pregnant or breastfeeding.

Select...

My body has accepted the stem cell transplant without major issues.

ATLANTIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 45 days of first nsts infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 45 days of first nsts infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 45 days of first nsts infusion 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 infusion related adverse events as per CTCAE common criteria guidelines.

Incidence of non-hematological adverse events

Secondary outcome measures

Antiviral activity

ATLANTIC Trial Design

1Treatment groups

Experimental Treatment

Group I: Norovirus -specific T-cell (NST) therapy for chronic norovirus infectionExperimental Treatment1 Intervention

This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or with primary immunodeficiency disorders (PID) who have not undergone HSCT. There are two arms in this study: Arm A: Participants who receive donor-derived NST therapy after HSCT Arm B: Participants who receive partially HLA matched NSTs. The following participants apply: Participants with PID who have not undergone HSCT Participants who undergo HSCT but do not have available donor derived NSTs Participants who have donors from whom NSTs cannot be generated due to norovirus seronegativity

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

208,109 Total Patients Enrolled

1 Trials studying Viral Infections

32 Patients Enrolled for Viral Infections

Michael Keller, MDPrincipal Investigator - CNH

Children's National Research Institute

3 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

Norovirus-specific T-cell (NST) therapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04691622 — Phase 1

Viral Infections Research Study Groups: Norovirus -specific T-cell (NST) therapy for chronic norovirus infection

Viral Infections Clinical Trial 2023: Norovirus-specific T-cell (NST) therapy Highlights & Side Effects. Trial Name: NCT04691622 — Phase 1

Norovirus-specific T-cell (NST) therapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04691622 — Phase 1

Frequently Asked Questions

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

Does the protocol for this clinical trial accept participants who are of a more advanced age?

"As per the listed eligibility requirements, this medical research trial is available to patients aged between 3 months and 80 years."

Answered by AI

To what degree is NST therapy hazardous to those receiving it?

"Since this is an early-phase clinical trial, there is limited data to suggest that Norovirus-specific T-cell (NST) therapy can be both effective and safe. Our team at Power thus ranked safety of NST a 1 on the scale."

Answered by AI

How many volunteers are participating in this research?

"Indeed, the information on clinicaltrials.gov reveals that this research endeavour is actively looking for participants to enroll in their trial. The study was first advertised on March 17th 2022 with an update made May 6th of that same year and 48 volunteers are sought from 2 distinct sites."

Answered by AI

Are there presently any opportunities to join the experiment?

"Clinicaltrials.gov affirms that this trial is actively enrolling patients, which it originally posted on March 17th 2022. Most recently, the details of this study were updated on May 6th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

Michael Keller 2022. "Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04691622.

All > Primary Immunodeficiency