A Phase II Safety and Tolerability Study of TCB008 in Patients With COVID-19

NCT04834128 | Withdrawn Phase 2 DMC

• 1 other identifier: TCB008-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II safety and tolerability study of expanded gamma delta T cell lymphocytes (TCB008) in patients diagnosed with COVID-19.

Conditions

COVID - 19

Keywords

ATMP

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Approx 1 year

Other Outcomes (2)

• Persistence of gamma delta T cells

  Approx 1 year

• Phenotype of gamma delta T cells

  Approx 1 year

Study Arms (1)

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).

Drug: TCB008

Interventions

TCB008 DRUG

administration of gamma delta T cells by IV bolus injection

γδ T cells (IMP, TCB008)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Biopharm: lead

Study Sites (1)

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, safety and tolerability, escalating dose, single arm study

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 6, 2021
• Study Start: December 13, 2021
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

GB (1)