Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000377730
Ethics application status
Approved
Date submitted
28/02/2022
Date registered
3/03/2022
Date last updated
8/02/2023
Date data sharing statement initially provided
3/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
SARS-CoV-2-specific T cell therapy for COVID-19
Scientific title
Phase I open-label clinical trial of allogeneic SARS-CoV-2-specific T cells for patients at risk of severe COVID-19
Secondary ID [1] 306559 0
nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 325455 0
Condition category
Condition code
Infection 322835 322835 0 0
Other infectious diseases
Respiratory 322848 322848 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
‘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.
Intervention code [1] 322989 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330616 0
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..
Timepoint [1] 330616 0
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 [1] 406981 0
The kinetics of functional SARS-CoV-2-specific T cells.
Timepoint [1] 406981 0
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.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
The sample size of 20 participants is expected to provide sufficient information for preliminary clinical evaluation of this therapy. The study has a 95 percent probability of observing at least one participant experiencing an AE if the probability of that event occurring is at least 14 percent, or affecting approximately 1 in 7 patients. Equivalent probabilities for observing AEs that affect 1 in 10 participants and 1 in 15 participants are 87.8 percent and 74.8 percent respectively.

Alternatively, the 95 percent confidence interval for the event rate would be (0 percent, 16.1 percent) if none of the 20 participants experience a particular AE, (0.9 percent, 23.6 percent) if 1 of 20 experience the AE, and (2.8 percent, 30.1 percent) if 2 of 20 experience the AE.

The secondary endpoint is the within-participant change in the proportion of functional virus-specific T cells, from Day 0 to Day 28 and at Day 84. With 20 patients, the study will have 90% power for an alpha equals 5 percent test to detect a difference in post-infusion versus pre-infusion levels of 0.76 standard deviations of the differences, and 80 percent power for 0.66 standard deviations.

The statistical analysis plan will be finalised prior to data lock. If there is a substantial amount of missing, unused or spurious data, the primary analyses will be repeated to assess the robustness of the results. Differences from the intention-to-treat analysis will be investigated. Deviations from the statistical analysis plan will be documented in the clinical study report.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2022
Actual
1/09/2022
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21853 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 36916 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 310892 0
Government body
Name [1] 310892 0
Queensland Health
Country [1] 310892 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston Road
Herston, Brisbane, Queenland 4006
Country
Australia
Secondary sponsor category [1] 312171 0
None
Name [1] 312171 0
Address [1] 312171 0
Country [1] 312171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310453 0
QIMR Berghofer Human Research Ethics Committee
Ethics committee address [1] 310453 0
Ethics committee country [1] 310453 0
Australia
Date submitted for ethics approval [1] 310453 0
18/02/2022
Approval date [1] 310453 0
23/03/2022
Ethics approval number [1] 310453 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117722 0
A/Prof Corey Smith
Address 117722 0
QIMR Berghofer Medical Research Institute
Translational and Human Immunology Laboratory
300 Herston Rd
Herston QLD 4006
Country 117722 0
Australia
Phone 117722 0
+61733620313
Fax 117722 0
Email 117722 0
Corey.smith@qimrberghofer.edu.au
Contact person for public queries
Name 117723 0
Michelle Neller
Address 117723 0
QIMR Berghofer Medical Research Institute
300 Herston Rd
Herston QLD 4006
Country 117723 0
Australia
Phone 117723 0
+61733620412
Fax 117723 0
Email 117723 0
immunotherapy@qimrberghofer.edu.au
Contact person for scientific queries
Name 117724 0
Corey Smith
Address 117724 0
QIMR Berghofer Medical Research Institute
300 Herston Rd
Herston QLD 4006
Country 117724 0
Australia
Phone 117724 0
+61733620313
Fax 117724 0
Email 117724 0
corey.smith@qimrberghofer.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sponsor discretion to not share, however de-identified data will be shared through publication in peer-reviewed journal articles and in relevant seminar presentations.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.