Viral Infection Clinical Trial
Official title:
Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
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.
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: 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 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 (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, 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. Investigators will test three doses: 1 x 10^7 /m^2, 2 x 10^7 /m^2, and 4 x 10^7 /m^2. Investigators will have a 45-day safety monitoring period for immediate toxicities following infusion. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05568953 -
An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity
|
Phase 2 | |
Not yet recruiting |
NCT05953233 -
School Inner City Air Study
|
N/A | |
Not yet recruiting |
NCT05902702 -
Isotonic Saline for Children With Bronchiolitis
|
N/A | |
Completed |
NCT01570283 -
ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT01159470 -
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children
|
N/A | |
Recruiting |
NCT02532452 -
Third Party Viral Specific T-cells (VSTs)
|
Phase 2 | |
Recruiting |
NCT05246098 -
REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI
|
||
Recruiting |
NCT05603650 -
Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
|
N/A | |
Completed |
NCT04525456 -
Immune Responses With Reduxium
|
N/A | |
Completed |
NCT04643678 -
Anakinra in the Management of COVID-19 Infection
|
Phase 2/Phase 3 | |
Completed |
NCT03189537 -
Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections
|
Phase 3 | |
Completed |
NCT04267809 -
Modulate Cellular Stress in the Immune Cells to Reduce Rate of Symptomatic Viral Infection
|
Phase 2 | |
Completed |
NCT00341081 -
Validation of Self-Reported Needle Sharing Among Injection Drug Users
|
N/A | |
Recruiting |
NCT04088916 -
Proviral DNA as a Target for HIV-1 Resistance Analysis
|
||
Terminated |
NCT04401410 -
Anti-SARS Cov-2 T Cell Infusions for COVID 19
|
Phase 1 | |
Terminated |
NCT00952185 -
Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
|
N/A | |
Recruiting |
NCT06149494 -
RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection
|
Phase 2 | |
Active, not recruiting |
NCT04254991 -
A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection
|
||
Completed |
NCT05897801 -
Distinguishing Bacterial and Viral Infections by MeMed BV® Test to Limit Gut Colonization by MDRO
|
||
Terminated |
NCT02696291 -
Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects
|
Phase 1 |