Your session is about to expire
← Back to Search
CAR T-cell Therapy
T Cell Therapy for COVID-19 (TONI Trial)
Phase 1
Recruiting
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
Karnofsky/Lansky score >70
Male and female participants of childbearing age must use highly effective birth control measures or practice abstinence
Must not have
Donation of cells would pose a physical or psychological risk to the donor
Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to CST infusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 45 days of cst infusion
Awards & highlights
Summary
This trial will test if a coronavirus-specific T cell therapy is safe for people who are immunocompromised and have had a hematopoietic stem cell transplant. The trial will have two parts, one for adults and one for children, testing different doses of the therapy. The goal is to see if the therapy can help prevent SARS-CoV-2 infection.
Who is the study for?
This trial is for immunocompromised patients aged 12-80 who are post allogeneic hematopoietic stem cell transplantation (HSCT). They must be at risk of COVID-19, have stable vital signs, normal organ function tests, and not be pregnant or breastfeeding. Participants should not have active COVID-19 infection or recent vaccinations and must agree to use effective birth control.
What is being tested?
The study is testing the safety of donor-derived coronavirus-specific T cells (CST) in preventing COVID-19 after HSCT. It's an open-label phase I trial with dose escalation to determine safe levels for adults and children in separate arms based on their age.
What are the potential side effects?
Potential side effects may include immune reactions due to infused T cells, such as fever or fatigue. There could also be risks associated with infusion itself like discomfort or infection at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out daily activities.
Select...
I am using effective birth control or practicing abstinence.
Select...
I am between 12 and 79 years old.
Select...
I had a stem cell transplant between 28 days and 4 months ago and am at risk for COVID-19.
Select...
I am not pregnant or breastfeeding.
Select...
My bone marrow transplant is successful with stable white blood cell counts.
Select...
I am between 2 and 80 years old.
Select...
My kidney function, measured by Cystatin C, is normal or near normal.
Select...
My blood pressure is normal without needing medication to raise it.
Select...
I am not pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
Donating cells would be harmful to my health or mental well-being.
Select...
I haven't had any experimental cell therapies like CAR T-cell therapy in the last 28 days.
Select...
I need extra oxygen or a machine to help me breathe due to lung disease.
Select...
I have not had a fever of 38.1°C or higher in the last week.
Select...
I do not have any ongoing serious infections that are getting worse despite treatment.
Select...
I haven't taken ruxolitinib or similar medications in the last 7 days.
Select...
My blood pressure is not controlled and is above the recommended levels for my age.
Select...
I haven't taken any immune system targeting drugs like ATG or Tocilizumab in the last 28 days.
Select...
I haven't had a fever of 38.1°C or higher in the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 45 days of cst infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 45 days of cst infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Multi-System Inflammatory Syndrome (MIS)
Incidence of Systemic Inflammatory Response Syndrome (SIRS) or CRS
Incidence of acute Graft Vs Host Disease (aGVHD) grade ≥3
+1 moreSecondary study objectives
Antiviral Activity
COVID-19 antiviral immunity using intracellular ELIspot assays
COVID-19 antiviral immunity using intracellular flow cytometry
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Prevention of SARS-CoV-2 infection in immunocompromised pediatric patientsExperimental Treatment1 Intervention
In this dose escalation trial, donor derive coronavirus-specific T cell (CST) (three doses, 1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for pediatric (≥12 years of age and \<18 years) HSCT recipients (Arm B).
Group II: Prevention of SARS-CoV-2 infection in immunocompromised adult patientsExperimental Treatment1 Intervention
In this dose escalation trial, donor derive coronavirus-specific T cell (CST) (three doses, 1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for adult (≥18 years of age and \<80 years) HSCT recipients (Arm A)
Find a Location
Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
218 Previous Clinical Trials
257,886 Total Patients Enrolled
1 Trials studying COVID-19
5,000 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your pulse pressure is more than 40 mmHg.Your white blood cell count is at least 500 cells per microliter.I am a teen who had a stem cell transplant recently and am at risk for COVID-19.Your oxygen levels have been consistently above 92% without needing extra oxygen for at least a week before starting the treatment.I am on a low dose of steroids, less than 0.5 mg/kg/day, for at least a week.Donating cells would be harmful to my health or mental well-being.You have unstable metabolism.I haven't had any experimental cell therapies like CAR T-cell therapy in the last 28 days.My platelet count is at least 20,000, even if I needed a transfusion to reach it.I need extra oxygen or a machine to help me breathe due to lung disease.Your AST blood test result is not more than 2.5 times the upper limit of normal.I have not had a fever of 38.1°C or higher in the last week.I haven't had any live vaccines in the last 30 days or a COVID-19 vaccine in the last 28 days.I am mostly able to care for myself and carry out daily activities.I do not have any ongoing serious infections that are getting worse despite treatment.You have a positive SARS-CoV-2 test showing that you have an active COVID-19 infection.I am between 12 and 79 years old.My blood pressure is not controlled and is above the recommended levels for my age.I haven't taken any immune system targeting drugs like ATG or Tocilizumab in the last 28 days.I had a stem cell transplant between 28 days and 4 months ago and am at risk for COVID-19.Your bilirubin levels are not more than twice the normal limit.I haven't taken immune checkpoint inhibitors like nivolumab or pembrolizumab in the last 3 months.I am not pregnant or breastfeeding.I am using effective birth control or practicing abstinence.I am diagnosed or suspected to have MIS according to CDC guidelines.I haven't taken ruxolitinib or similar medications in the last 7 days.I have had or currently have severe COVID-19 complications.I am a healthy donor for a stem cell transplant, meeting all FDA health requirements.My bone marrow transplant is successful with stable white blood cell counts.My hemoglobin level is at least 8.0g/dl, possibly after a transfusion.Your heart beats more than 120 times in a minute.I expect to need a blood transfusion within 2 days of getting a CST infusion.I haven't had a fever of 38.1°C or higher in the last week.I am between 2 and 80 years old.Your breathing rate is faster than 20 breaths per minute.I have moderate heart failure symptoms.I am between 18 and 79 years old and had a stem cell transplant from a donor 1 to 4 months ago.Your ALT levels in the blood are not more than 2.5 times the upper limit of normal.My kidney function, measured by Cystatin C, is normal or near normal.My blood pressure is normal without needing medication to raise it.I am not pregnant.Your blood pressure is too low.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention of SARS-CoV-2 infection in immunocompromised adult patients
- Group 2: Prevention of SARS-CoV-2 infection in immunocompromised pediatric patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger