SARS-CoV-2-specific T cell therapy for COVID-19

Phase 1

Recruiting

• Conditions: SARS-CoV-2; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622000377730
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-03
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events observed in Blood tests and vital signs including Temperature via tympanic thermometer, heart/pulse rate and oxygen saturation by pulse oximeter, Blood pressure by sphygmomanometer and respiratory rate by count..[All adverse events will be collected from the first infusion visit (Day 0) and will be updated for the preceding period during the Day 14 and Day 28 visits. Safety blood tests (haematology and biochemistry) will be collected at each visit (Day 0, Day 14, Day 28 and Day 84). Vital signs observations will be done during and immediately following each T cell infusion (Day 0 and Day 14). From Day 28 to Day 84, a targeted group of adverse events will be collected – adverse events relating to graft-versus-host disease, infection and thrombosis. During this period, serious adverse events of any type that are deemed to be possibly, probably or definitely related to the investigational product will also be collected.]

Secondary Outcome Measures

Name	Time	Method
The kinetics of functional SARS-CoV-2-specific T cells.[Blood will be collected at each study visit (all infusions and follow-up visits) to allow the examination of peripheral blood mononuclear cells. These cells will be analysed to assess their phenotype and function over the course of the trial to determine any changes.]