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.
4 Primary · 4 Secondary · Reporting Duration: Within 45 days of CST infusion
Awards & Highlights
2 Treatment Groups
Prevention of SARS-CoV-2 infection in immunocompromised pediatric patients
1 of 2
Prevention of SARS-CoV-2 infection in immunocompromised adult patients
1 of 2
24 Total Participants · 2 Treatment Groups
Primary Treatment: Coronavirus-specific T cell (CST) · No Placebo Group · Phase 1
Who is running the clinical trial?
Age 12 - 80 · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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" - Anonymous Online Contributor
Does this research include elderly participants?
"According to the research protocol, participants must be between 12 and 80 years old." - Anonymous Online Contributor