TCB008 in Patients With COVID-19

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2022

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.

Interventions

  • Drug: TCB008
    • administration of gamma delta T cells by IV bolus injection

Arms, Groups and Cohorts

  • Experimental: γδ T cells (IMP, TCB008)
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of treatment emergent adverse events (AEs) – Safety
    • Time Frame: 28 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: 28 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

Participating in This Clinical Trial

Inclusion Criteria

1. 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 2. Age 18-65 years (inclusive) at the time of signing ICF 3. Any gender 4. 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:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TC Biopharm
  • Provider of Information About this Clinical Study
    • Sponsor

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