Status:
WITHDRAWN
A Phase II Safety and Tolerability Study of TCB008 in Patients With COVID-19
Lead Sponsor:
TC Biopharm
Conditions:
COVID - 19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A Phase II safety and tolerability study of expanded gamma delta T cell lymphocytes (TCB008) in patients diagnosed with COVID-19.
Detailed Description
The aim of this Phase II study is to evaluate the safety and tolerability of ex-vivo expanded gamma delta T-cells (TCB008) manufactured from a single allogeneic unmatched or partially, randomly matche...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF);
- \- willingness and capability to complete all the study procedures
- Age 18-65 years (inclusive) at the time of signing ICF
- Any gender
- Patients with a positive diagnosis of COVID-19 either identified in the community as at risk of progression of disease or
- already hospitalized with new changes on CXR or CT scan compatible with COVID19, or
- patients requiring supplemental oxygen, but for whom dexamethasone is not yet indicated according to current standard of care recommendations.
- The product would be indicated for patients categorized as per the WHO ordinal scale 2,3 or 4: i.e., ambulatory (or community identified) patients with limitations of activity, judged as at risk for progression of disease, as well as hospitalized patients not yet requiring oxygen therapy or receiving non-invasive low flow oxygen therapy, which does not yet indicate the need to commence dexamethasone therapy.
- Exclusion Criteria
- Patients requiring high-flow oxygen therapy and/or dexamethasone according to the current standard of care.
- Patients suffering from severe cognitive impairment or mental illness
- Pregnant and/or lactating women
- Patients participating in other CTIMP clinical studies at the same time
- Active autoimmune disease or Graft versus Host Disease (GVHD)
- Patients with any major comorbidity (e.g., diabetes, cardiovascular and pulmonary diseases, malignancies on active treatment) unless their pre-morbid Karnofsky performance status was ≥ 80%
- Patients with documented history of immunological disorders
- Immunocompromised patients defined as those with human immunodeficiency virus infection with a CD4 cell count of less than 200 per microliter or uncontrolled viremia, prolonged use of glucocorticoids or other immunomodulating medications, a history of bone marrow or organ transplantation
- ALT / AST\> 5 times the upper limit of the normal
- Neutrophils \<500 / mm3
- Platelets \<50.000 / mm3
- Patients known or suspected to have sensitivity against mouse immunoglobulins or iron-dextran.
Exclusion
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04834128
Start Date
December 13 2021
End Date
April 13 2022
Last Update
April 21 2023
Active Locations (1)
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1
Royal Victoria Infirmary
Newcastle, United Kingdom