Viral InfectionPhase 1ATLANTICNCT04691622
Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
A Phase 1 study testing Norovirus -specific T-cell (NST) therapy in people with Viral Infection and Hematopoietic Stem Cell Transplantation (HSCT), run by Children's National Research Institute at 3 sites in United States.
Trial summary
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 who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT)… Read more about this study
- Who is it for?
- Ages 3 months to 80 years
- Conditions the study is for
- Viral Infection, Hematopoietic Stem Cell Transplantation (HSCT), Primary Immunodeficiency Disorders (PID)
- What is being tested?
- Norovirus -specific T-cell (NST) therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Mar 2022to 30 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant Inclusion Criteria for NST Infusion:
- Participants must meet one of the following criteria:
- Recipient of prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood OR
- Primary immunodeficiency disorder (as defined by clinical and laboratory evaluations)81 and have not undergone HSCT, OR
- Recipients of solid organ transplant.
- Documentation of chronic norovirus infection:
Show all 40Show fewer
- 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.
- Participants receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to <0.5 mg/kg/day of prednisone (or equivalent) a minimum of 7 days prior to infusion.
- Treatment with enteral topical steroids such as Budesonide at standard doses may be continued if previously utilized but should not be newly initiated in the 3 months after NST therapy.
- For participants who have undergone HSCT, participants must have stable donor chimerism within the 30 days prior to NST infusion.
- Stability will be defined as i. >95% donor chimerism in CD33 and/or whole blood chimerism. OR ii. >90% donor chimerism with <5% change between subsequent tests separated by at least 1 week.
- For recipients of solid organ transplants, participants must have stable graft function on maintenance immunosuppression, without evidence of rejection in the past 2 months prior to infusion, as defined by:
- Stability of relevant functional testing in the previous 2 months, defined as: i. Renal transplant: renal function ≥ grade 3 per the National Kidney Foundation K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease (2002) ii. Cardiac transplant: maintenance of LVEF >40% iii. Lung transplant: lack of baseline oxygen requirement iv. Liver transplant: AST/ALT ≤3x upper limit normal and bilirubin ≤2x upper limit normal b. Donor-derived cell free DNA <2x upper limits for assay in the previous 2 months, c. Stable donor-specific antibody profile in the previous 2 months. i. No increase in antibody titers between most recent testing in the previous 2 months and prior testing.
- Karnofsky/Lansky score >50
- 3 months to 80 years of age at enrollment.
- ANC ≥500/ul.
- Hemoglobin ≥7.0g/dl (level can be achieved with transfusion).
- Platelets ≥20 K/ul (level can be achieved with transfusion).
- Bilirubin ≤2x upper limit normal.
- AST ≤3x upper limit normal.
- Serum creatinine ≤2x upper limit normal OR estimated GFR ≥30 ml/hr.
- Pulse oximetry of ≥90% on room air.
- Negative pregnancy test in female participant of childbearing age.
- Written informed consent and/or signed assent line from participant, parent or guardian.
- Donor Inclusion Criteria:
- Donors who have fulfilled eligibility as per United States Food and Drug Administration (FDA) regulations outlined in 21 Code of Federal Regulations (CFR) 1271 subpart C. This includes that donors have been deemed in good health by donor physician based on physical examination and laboratory testing. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for NST generation provided that there are no new reasons for ineligibility since the stem cell collection.
- For third-party banking, donors must be between 2 to 35 years of age (females) or 2 to 40 years of age (males).
- Donor or guardian of pediatric donor capable of providing informed consent.
- Donor (related or unrelated) must have completed Infectious Disease (ID) testing up to 7 days before or after the collection of blood for NST manufacturing. The following tests will be performed:
- HBsAg
- HBc Antibody
- HCV Antibody
- HIV 1/2 Antibody
- HTLV I/II Antibody
- T. Cruzi Antibody (Chagas)
- CMV Total Antibody
- Syphilis (T. Pallidum IgG and IgM)
- HBV, HCV, HIV Nucleic Acid testing (NAT)
- WNV NAT
- Female donors of childbearing age must have a negative pregnancy test and not be lactating.
Who cannot join
- Participants Exclusion Criteria for NST Infusion:
- Participants receiving biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days prior to NST infusion, including ATG, Alemtuzumab, Basiliximab, Tocilizumab, Brentuximab, or other medications under this category as determined by the investigators.
- If alemtuzumab has been received within 6 weeks prior to NST infusion, plasma levels should be obtained to ensure drug clearance (≤0.16 pg/ml).
- Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to NST infusion.
- Participants with SCID who have undergone α/β TCR depleted HSCT within the past 100 days post-transplant.
- Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to NST infusion.
Show all 25Show fewer
- Participants with uncontrolled or progressing infections other than norovirus. Uncontrolled infections are defined as bacterial, fungal, or non-targeted viral infections with either clinical signs of worsening despite standard therapy, or chronic gastrointestinal symptoms that may be attributed to the uncontrolled infection. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to NST infusion and or no chronic gastrointestinal symptoms associated with this bacterial infection.
- For fungal infections, participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to NST infusion.
- Participants must not have other active gastrointestinal infections to which symptoms may be attributable, including parasitic infections (cryptosporidium, giardiasis), viral infections aside from norovirus (CMV colitis, rotavirus, adenovirus), or bacterial infections with C. difficile, Yersinia, Campylobacter, Salmonella, Shigella, or enteroinvasive or enterotoxigenic E. coli.
- Testing for unrelated gastrointestinal (GI) infections must be performed within 14 days prior to NST infusion, and must include: i. Crytosporidium/Giardia testing via antigen or PCR testing. ii. Stool viral testing for rotavirus and adenovirus via antigen or PCR testing.
- Stool bacterial culture or PCR testing. iv. C. difficile toxin PCR. b) Determination of active infection versus chronic carriage/shedding will be made by the investigators and clinical providers and will depend on the presence of clinical symptoms corresponding with the timing of positive test results, presence of a clinical response to targeted therapy, and by histological or other testing if clinically indicated.
- Participants with active and uncontrolled relapse of malignancy (if applicable).
- Failure of primary engraftment is defined as failure to achieve platelet and/or neutrophil engraftment (ANC <500/ul and/or platelets <20 K/ul) following HSCT.
- Secondary graft failure is defined as <5% donor chimerism (CD3+ or CD34+) or permanent loss of neutrophil and/or platelet engraftment (ANC <500/ul and/or platelets <20 K/ul) at any time after primary engraftment.
- Participants with symptomatic gastrointestinal conditions aside from norovirus, including active inflammatory bowel disease or graft versus host disease (grades 2 to 4).
- Participants who have received a small bowel transplant.
- Participants receiving checkpoint inhibitors within the previous 3 months prior to NST infusion, including nivolumab, pembrolizumab, or other related medications.
- For SOT recipients, alteration in immunosuppression as follows:
- Any intensification of immunosuppression (including but not limited to pulse dose corticosteroids or new biologic therapies) in the previous 2 months,
- Alteration of maintenance immunosuppression (including changes in the number of agents or dosing goals) in the previous month.
- Participants who have received enteral immunoglobulin, nitazoxanide, or other experimental therapies for norovirus infection within 28 days prior to NST infusion.
- Co-enrollment in other trials is restricted, other than enrollment on natural history or observational studies. Study staff should be notified of co-enrollment as it may require the approval of the investigator or sponsor.
- Donor Exclusion Criteria:
- 1. Donation of cells would pose a physical or psychological risk to the donor
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Robin Avery, MD, 4432874694, ravery4@jhmi.edu
Robin Avery, MD
- Recruiting
National Institutes of Health (NIH)
Bethesda, Maryland, 20892
Alison Han, MD, 301-480-5722, alison.han@nih.gov
Alison Han, MD
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Michael Keller, MD, 202-476-5843, MKeller@childrensnational.org
Fahmida Hoq, MBBS, MS, 202-476-3634, fhoq@childrensnational.org
About this study
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 who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.
Read the detailed description
This is an open label, phase I study of norovirus-specific T-cell immunotherapy for treatment of participants with primary immunodeficiency disorders (PID) and chronic norovirus. This study is designed to assess the safety of norovirus-specific T-cell (NST) infusion in this population. 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 have undergone HSCT but do not have available donor derived NSTs, or those for whom NSTs cannot be generated due to norovirus seronegativity.
- Participants who have undergone SOT.
Participants will be monitored for infusion-related reactions and GVHD for 1 year following first infusion. During this time, participants will be accessed with regard to the length and quantity of norovirus shedding in stool, and gastrointestinal and constitutional symptoms will be scored by clinicians and participants. Correlative studies of T-cell immune reconstitution against norovirus, norovirus genomic sequences, and composition of the fecal microbiome will also be accessed.
The primary purpose of this phase I study is to assess the safety of administering donor-derived or partially HLA-matched NSTs in immunocompromised participants with chronic norovirus infections. Related and unrelated donors of participants who have chronic norovirus infection after HSCT will be enrolled for screening and production of NSTs from peripheral blood. Following product manufacturing, participants who have undergone HSCT (Arm A) will receive donor-derived NSTs. For participants with PID who have not undergone HSCT or recipients of SOT (Arm B), high-resolution HLA typing of the participant will be utilized for an inquiry of the NST bank to determine if a partially HLA-matched NST product exists that has antiviral activity mediated through one or more shared HLA alleles. Participants who have undergone HSCT but either do not have available donors for NST generation, or who have donors from whom NSTs cannot be generated due to norovirus seronegativity will also be eligible for inquiry for treatment with partially HLA-matched NSTs if available under study Arm B.
This will be a dose escalation study with two arms. Participants who have undergone HSCT will be enrolled on Arm A and receive NSTs derived from their HSCT donor. Participants with a diagnosis of PID who have not undergone HSCT, recipients of SOT, or participants who have undergone HSCT but do not have available donor-derived NSTs will be enrolled on Arm B and receive partially HLA-matched NSTs. We will test three doses: 1x107 /m2, 2x107 /m2, and 4x107 /m2. Investigators will have a 45-day safety monitoring period for immediate toxicities following infusion.
- Conditions
- Viral Infection, Hematopoietic Stem Cell Transplantation (HSCT), Primary Immunodeficiency Disorders (PID)
- Being tested
- Norovirus -specific T-cell (NST) therapy
- Medical subject headings
- Virus Diseases, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norovirus -specific T-cell (NST) therapyBiological
Arm A: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion.
Arm B: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion.
| Study group | Role | What they receive |
|---|---|---|
| Norovirus -specific T-cell (NST) therapy for chronic norovirus infection | Experimental | 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 have undergone HSCT but do not have available donor derived NSTs, or those for whom NSTs cannot be generated due to norovirus seronegativity.
* Participants who have undergone SOT. Receives: Biological: Norovirus -specific T-cell (NST) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute GvHD (grade III-IV)
Number of patients with acute GvHD grades III-IV
Measured: Within 45 days of first NSTs infusion
Incidence of infusion related adverse events as per CTCAE common criteria guidelines.
Number of patients with Grades 3-5 infusion-related adverse events
Measured: Within 45 days of first NSTs infusion
Incidence of non-hematological adverse events
Number of patients with Grades 4-5 non-hematological adverse events related to the NST product within 45 days of the first infusion
Measured: Within 45 days of first NSTs infusion
Secondary outcomes (1)
Antiviral activity
Antiviral activity will determined by measurements in viral loads by RT-PCR from stool samples in comparison to the mean baseline viral load.
Measured: Stool viral loads will be evaluated for 12 months following the final NST infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start17 Mar 2022
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Keller, Children's National Research Institute
- Investigators
- Michael Keller, MD, Principal investigator, CNH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691622
- Sponsor's protocol ID
- Pro00014658
- Acronym
- ATLANTIC
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2020
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available via publication. All raw data, methodologies and statistical analyses will also be made available upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
- ClinicalTrials.gov ID
- NCT04691622
- Acronym / sponsor ID
- ATLANTIC / Pro00014658
- Conditions
- Viral Infection, Hematopoietic Stem Cell Transplantation (HSCT), Primary Immunodeficiency Disorders (PID)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.
Detailed description
This is an open label, phase I study of norovirus-specific T-cell immunotherapy for treatment of participants with primary immunodeficiency disorders (PID) and chronic norovirus. This study is designed to assess the safety of norovirus-specific T-cell (NST) infusion in this population. 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 have undergone HSCT but do not have available donor derived NSTs, or those for whom NSTs cannot be generated due to norovirus seronegativity.
- Participants who have undergone SOT.
Participants will be monitored for infusion-related reactions and GVHD for 1 year following first infusion. During this time, participants will be accessed with regard to the length and quantity of norovirus shedding in stool, and gastrointestinal and constitutional symptoms will be scored by clinicians and participants. Correlative studies of T-cell immune reconstitution against norovirus, norovirus genomic sequences, and composition of the fecal microbiome will also be accessed.
The primary purpose of this phase I study is to assess the safety of administering donor-derived or partially HLA-matched NSTs in immunocompromised participants with chronic norovirus infections. Related and unrelated donors of participants who have chronic norovirus infection after HSCT will be enrolled for screening and production of NSTs from peripheral blood. Following product manufacturing, participants who have undergone HSCT (Arm A) will receive donor-derived NSTs. For participants with PID who have not undergone HSCT or recipients of SOT (Arm B), high-resolution HLA typing of the participant will be utilized for an inquiry of the NST bank to determine if a partially HLA-matched NST product exists that has antiviral activity mediated through one or more shared HLA alleles. Participants who have undergone HSCT but either do not have available donors for NST generation, or who have donors from whom NSTs cannot be generated due to norovirus seronegativity will also be eligible for inquiry for treatment with partially HLA-matched NSTs if available under study Arm B.
This will be a dose escalation study with two arms. Participants who have undergone HSCT will be enrolled on Arm A and receive NSTs derived from their HSCT donor. Participants with a diagnosis of PID who have not undergone HSCT, recipients of SOT, or participants who have undergone HSCT but do not have available donor-derived NSTs will be enrolled on Arm B and receive partially HLA-matched NSTs. We will test three doses: 1x107 /m2, 2x107 /m2, and 4x107 /m2. Investigators will have a 45-day safety monitoring period for immediate toxicities following infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norovirus -specific T-cell (NST) therapy for chronic norovirus infection | Experimental | Biological: Norovirus -specific T-cell (NST) therapyThis 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 have undergone HSCT but do not have available donor derived NSTs, or those for whom NSTs cannot be generated due to norovirus seronegativity. * Participants who have undergone SOT. |
Who may qualify
- Ages
- 3 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (40 listed)
- Participants must meet one of the following criteria:
- Documentation of chronic norovirus infection:
- Participants receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to <0.5 mg/kg/day of prednisone (or equivalent) a minimum of 7 days prior to infusion.
- For participants who have undergone HSCT, participants must have stable donor chimerism within the 30 days prior to NST infusion.
- For recipients of solid organ transplants, participants must have stable graft function on maintenance immunosuppression, without evidence of rejection in the past 2 months prior to infusion, as defined by:
Key exclusion criteria (25 listed)
- Participants receiving biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days prior to NST infusion, including ATG, Alemtuzumab, Basiliximab, Tocilizumab, Brentuximab, or other medications under this category as determined by the investigators.
- Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to NST infusion.
- Participants with SCID who have undergone α/β TCR depleted HSCT within the past 100 days post-transplant.
- Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to NST infusion.
- Participants with uncontrolled or progressing infections other than norovirus. Uncontrolled infections are defined as bacterial, fungal, or non-targeted viral infections with either clinical signs of worsening despite standard therapy, or chronic gastrointestinal symptoms that may be attributed to the uncontrolled infection. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norovirus -specific T-cell (NST) therapyArm A: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion. Arm B: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion. | Biological | Norovirus -specific T-cell (NST) therapy for chronic norovirus infection |
Primary outcome
Incidence of acute GvHD (grade III-IV)
Time frame: Within 45 days of first NSTs infusion
Number of patients with acute GvHD grades III-IV
Incidence of infusion related adverse events as per CTCAE common criteria guidelines.
Time frame: Within 45 days of first NSTs infusion
Number of patients with Grades 3-5 infusion-related adverse events
Incidence of non-hematological adverse events
Time frame: Within 45 days of first NSTs infusion
Number of patients with Grades 4-5 non-hematological adverse events related to the NST product within 45 days of the first infusion
1 secondary outcome
Antiviral activity
Time frame: Stool viral loads will be evaluated for 12 months following the final NST infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. Data will be made available via publication. All raw data, methodologies and statistical analyses will also be made available upon publication.
Related trials for Viral Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Keller, MD principal investigator
CNH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Norovirus -specific T-cell (NST) therapy in people with Viral Infection and Hematopoietic Stem Cell Transplantation (HSCT), run by Children's National Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Keller, MD (202-476-5843, MKeller@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute GvHD (grade III-IV) (time frame: Within 45 days of first NSTs infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.