Is NCT04691622 recruiting in Baltimore, MD?

Yes, NCT04691622 is currently recruiting participants at its Baltimore, MD location. This viral infection clinical trial is actively enrolling qualified participants.

How do I join the viral infection clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Viral Infection Clinical Trial in Baltimore, MD

About This Viral Infection Study in Baltimore

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.

Sponsor: Children's National Research Institute

Who Can Participate

Inclusion Criteria

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: 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.

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 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. a. 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: a. 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:

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)

Female donors of childbearing age must have a negative pregnancy test and not be lactating.

Exclusion Criteria

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. a) 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.

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. a) 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. iii. 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT04691622) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Viral Infection Treatment Options in Baltimore, MD

If you're searching for viral infection treatment options in Baltimore, MD, this clinical trial (NCT04691622) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced viral infection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all viral infection clinical trials near you to find additional studies recruiting in your area.

Viral Infection Clinical Trial in Baltimore, MD

Expert Care in Baltimore

IRB Approved

No-Cost Care

Apply for This Baltimore Location

Why Participate?

Simple Process