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T Cell Therapy for COVID-19 (TONI Trial)
TONI Trial 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.
TONI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTONI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TONI Trial Design
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- 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.
- Group 1: Prevention of SARS-CoV-2 infection in immunocompromised adult patients
- Group 2: Prevention of SARS-CoV-2 infection in immunocompromised pediatric patients
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is this research project accepting new participants at present?
"According to the latest information gleaned from clinicaltrials.gov, this research is recruiting participants with its initial appearance on October 19th 2021 and last edited on September 1st 2022."
How hazardous is the Coronavirus-specific T cell (CST) for human health?
"The safety of Coronavirus-specific T cell (CST) is estimated to be a 1 as this is a Phase 1 trial, reflecting the limited information available in regards to saftey and efficacy."
What is the cap on participants for this scientific investigation?
"Affirmative, the data hosted on clinicaltrials.gov states that this medical investigation is presently recruiting volunteers. The trial was originally advertised on October 19th 2021 and its most recent update occurred on September 1st 2022. Two locations need to enrol 24 participants in total."
What is the underlying aim of this clinical experiment?
"The primary outcome over the 45 day period will be an assessment of grade ≥3 infusion-related Adverse Events (AEs). Secondary outcomes include a tracking of infused T-Cell Receptor Beta repertoire with deep sequencing, COVID-19 antiviral immunity evaluation through ELIspot assays and other phenotypic/functional studies, as well as measurement of SARS-CoV-2 viral load from oral/salivary or respiratory samples."
Are there any opportunities to partake in this trial?
"This clinical trial is enrolling 24 individuals of ages 12-80 who are suffering from infections. To be eligible, patients must meet the following prerequisites: have a Karnofsky/Lansky score greater than 70, absolute neutrophil count (ANC) more than 500/ul and hemoglobin more than 8g/dl; additionally any steroids treatment given to treat GVHD or other reasons should not exceed 0.5 mg per kg per day prednisone in equivalent dosage at least 7 days prior to infusion; platelets also need to be 20k/ul before enrollment. Furthermore, participants aged 18 years up until 80 with"
Does this research include elderly participants?
"According to the research protocol, participants must be between 12 and 80 years old."
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