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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)

Must not have

Participants with active and uncontrolled relapse of malignancy (if applicable).

Donation of cells would pose a physical or psychological risk to the donor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 45 days of first nsts infusion

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

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I do not have HTLV I/II.

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

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

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I can do most activities but may need help.

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I am between 3 months and 80 years old.

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

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I have Hepatitis C.

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I am not pregnant or breastfeeding.

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

Exclusion Criteria

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

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My cancer is not currently under control.

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Donating cells would be harmful to my health or mental well-being.

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My bone marrow transplant didn't restore my blood cell counts.

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My body has not fully accepted a previous transplant.

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I do not have any active infections in my stomach or intestines.

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I have a serious gut condition, but it's not norovirus.

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I have SCID and received a specific stem cell transplant within the last 100 days.

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I haven't taken any experimental treatments for norovirus in the last 28 days.

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

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 infusion related adverse events as per CTCAE common criteria guidelines.

Incidence of non-hematological adverse events

Secondary study objectives

Antiviral activity

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: 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: 1. Arm A: Participants who receive donor-derived NST therapy after HSCT 2. 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 / 21Eligibility criteria met