None listed
Conditions
Brief summary
The trial is testing a new therapy to treat the virus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes COVID-19. The new treatment is called T cell immunotherapy. It aims to use T cells, a type of immune cell, to fight disease. This therapy is given via infusion into the bloodstream (intravenous infusion). Researchers at QIMR Berghofer Medical Research Institute have grown T cell therapies from blood samples donated by healthy people who have an immune response against SARS-CoV-2. These blood donors tested positive for SARS-CoV-2 more than a year before their blood donation, so their immune system has a memory of the virus and is able to fight it. Their anti-viral T cells have been grown in the laboratory to large numbers, and then frozen in single doses for the treatment of future patients. The main purpose of this clinical trial is to see if the T cell therapy is safe for people who have tested positive for SARS-CoV-2 and are at risk of developing severe COVID-19 because they have either received a transplant, chemotherapy, or a treatment that suppresses their immune system. We will recruit 20 participants in the trial. They will be matched with the most suitable batch of T cell therapy and then receive two intravenous infusions of T cells approximately 2 weeks apart at Royal Brisbane and Women’s Hospital. Monitoring of participants includes physical assessments, blood tests and nasal swabs. There will be five study visits over an approximately 3-month period.
Interventions
‘SARS-CoV-2-specific T cells THI-COV’, and consists of T cells targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Investigational Product (IP) has been be generated at Q-Gen Cell Therapeutics from the peripheral blood of healthy donors recruited through QIMR Berghofer project P3684. Recruited donors are now convalescent following previous exposure to SARS-CoV-2 infection. Batches of IP will be selected for participants based on human leukocyte antigen matching. The safety of
‘SARS-CoV-2-specific T cells THI-COV’, and consists of T cells targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Investigational Product (IP) has been be generated at Q-Gen Cell Therapeutics from the peripheral blood of healthy donors recruited through QIMR Berghofer project P3684. Recruited donors are now convalescent following previous exposure to SARS-CoV-2 infection. Batches of IP will be selected for participants based on human leukocyte antigen matching. The safety of the IP in a therapeutic setting will be tested in 20 patients who have SARS-CoV-2 and are at high risk of developing severe COVID-19 due to immunosuppression. Participants will be recruited from Royal Brisbane and Women’s Hospital. Two intravenous infusions of 4 × 10^7 cells/infusion will be given 14 days (plus or minus 3 days) apart. Participants will be assessed on Days 0, 14, 28 and 84 for safety, and immunological and virological studies will be conducted. The IP will be administered intravenously over 5–10 min by a qualified person (e.g. registered nurse or clinician). This will be followed by a saline flush, which will take an additional 5–10 min.
Sponsors
QIMR Berghofer Medical Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or above 2. Active SARS-CoV-2 infection, confirmed by rapid antigen test or polymerase chain reaction 3. Immunosuppression due to: transplantation, receipt of immunosuppressive therapy, or receipt of chemotherapy to treat malignancy 4. Availability of a suitable batch of Investigational Product
Exclusion criteria
1. Psychiatric condition that may compromise the ability to participate in this trial 2. Women who are pregnant, lactating or women of child-bearing potential who are unwilling to use adequate contraception 3. Any other medical condition that, in the view of the Investigator, would prohibit participation 4. Participants who have undergone prior allogeneic HSCT and have active acute graft-versus-host disease (GvHD) grade greater than or equal to 2 or chronic GvHD requiring greater than or equal to 0.5 mg/kg prednisolone
Outcome results
None listed