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New treatment option for Viral Infection
Official title Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
ClinicalTrials.gov ID: NCT04691622
What this study is testing
What is Norovirus -specific T-cell (NST) therapy?
Norovirus -specific T-cell (NST) therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for viral infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 80
You may be able to join if
- Participant 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...
- Primary immunodeficiency disorder (as defined by clinical and laboratory evaluations)81 and have not undergone HSCT, OR
- Recipients of solid organ transplant.
You likely can't join if
- 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...
- Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies...
- 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...
See the full eligibility criteria
Who can join
- Participant 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: 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...
- 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. a. Treatment with enteral...
- For participants who have undergone HSCT, participants must have stable donor chimerism within the 30 days prior to NST infusion. a. Stability will be defined as i. \>95% donor chimerism in CD33 and/or whole blood...
- 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: a. Stability...
- 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
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States; Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.