COVID - 19Phase 2NCT04834128
A Phase II Safety and Tolerability Study of TCB008 in Patients With COVID-19
A Phase 2 study testing TCB008 in people with COVID - 19, run by TC Biopharm at 1 site in United Kingdom.
Trial summary
A Phase II safety and tolerability study of expanded gamma delta T cell lymphocytes (TCB008) in patients diagnosed with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID - 19
- What is being tested?
- TCB008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2021to 13 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Safety and Tolerability, Inter-patient Pre-defined Dose Study of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) in Patients Diagnosed With COVID-19
A Phase II safety and tolerability study of expanded gamma delta T cell lymphocytes (TCB008) in patients diagnosed with COVID-19.
Read the 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 matched, unrelated donor, in patients with COVID-19.
The trial is designed to identify an optimal, safe dose of allogeneic γδ T cells in a population of patients with COVID-19. There will be 4 patient Cohorts. Cohorts 1 - 3 will receive a pre-defined dosing schedule, with Cohort 4 being treated with a dose selected upon completion of the first 3 Cohorts. In order to investigate immunogenicity assessment/sensitisation effects, patients in the expansion cohort who do not experience adverse reactions meeting dose limiting toxicity (DLT) criteria after the first administration will receive re-infusion with the same dose on Day 10 after the first infusion.
- Conditions
- COVID - 19
- Being tested
- TCB008
- Keywords
- ATMP
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCB008Drug
administration of gamma delta T cells by IV bolus injection
| Study group | Role | What they receive |
|---|---|---|
| γδ T cells (IMP, TCB008) | Experimental | Patients will receive an infusion of γδ T cells (IMP, TCB008) following informed consent after admission to hospital for SARS-CoV-2 infection (COVID-19). Receives: Drug: TCB008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of treatment emergent adverse events (AEs) - Safety
Safety of IMP assessed by incidence of treatment-emergent adverse events (AEs) per patient, graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: 30 and 90 days after IMP administration
Incidence of dose-limiting toxicities (DLTs) - Tolerability
Tolerability of IMP assessed by incidence of dose-limiting toxicities (DLT's) graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: 30 and 90 days after IMP administration
Establish Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) - Tolerability
Tolerability of IMP assessed by incidence of dose-limiting toxicities (DLT's) graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: Approx 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start13 Dec 2021
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Why it stopped: The study was stopped because of the current status of the COVID-19 epidemic in the United Kingdom, and also because the trial involved parenterally administered IMP and a period of inpatient care and extensive outpatient visits and investigations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, safety and tolerability, escalating dose, single arm study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834128
- Sponsor's protocol ID
- TCB008-002
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety and Tolerability, Inter-patient Pre-defined Dose Study of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) in Patients Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT04834128
- Acronym / sponsor ID
- TCB008-002
- Conditions
- COVID - 19
- Keywords
- ATMP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped because of the current status of the COVID-19 epidemic in the United Kingdom, and also because the trial involved parenterally administered IMP and a period of inpatient care and extensive outpatient visits and investigations.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TC BiopharmIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 matched, unrelated donor, in patients with COVID-19.
The trial is designed to identify an optimal, safe dose of allogeneic γδ T cells in a population of patients with COVID-19. There will be 4 patient Cohorts. Cohorts 1 - 3 will receive a pre-defined dosing schedule, with Cohort 4 being treated with a dose selected upon completion of the first 3 Cohorts. In order to investigate immunogenicity assessment/sensitisation effects, patients in the expansion cohort who do not experience adverse reactions meeting dose limiting toxicity (DLT) criteria after the first administration will receive re-infusion with the same dose on Day 10 after the first infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, safety and tolerability, escalating dose, single arm study
| Arm | Type | Receives |
|---|---|---|
| γδ T cells (IMP, TCB008) | Experimental | Drug: TCB008Patients will receive an infusion of γδ T cells (IMP, TCB008) following informed consent after admission to hospital for SARS-CoV-2 infection (COVID-19). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF);
- 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
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCB008administration of gamma delta T cells by IV bolus injection | Drug | γδ T cells (IMP, TCB008) |
Primary outcome
Assessment of treatment emergent adverse events (AEs) - Safety
Time frame: 30 and 90 days after IMP administration
Safety of IMP assessed by incidence of treatment-emergent adverse events (AEs) per patient, graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Incidence of dose-limiting toxicities (DLTs) - Tolerability
Time frame: 30 and 90 days after IMP administration
Tolerability of IMP assessed by incidence of dose-limiting toxicities (DLT's) graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Establish Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) - Tolerability
Time frame: Approx 1 year
Tolerability of IMP assessed by incidence of dose-limiting toxicities (DLT's) graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCB008 in people with COVID - 19, run by TC Biopharm at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of treatment emergent adverse events (AEs) - Safety (time frame: 30 and 90 days after IMP administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.