Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

KK Women's and Children's Hospital18 enrolled

Overview

The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections.

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients. The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections. Part Two of this project is to assess the safety and efficacy of these T cells in patients with COVID-19.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

SARS-CoV-2 Specific T CellsBIOLOGICAL

Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.

Eligibility

Sex: ALLMin age: 1 YearMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 1 to 90 years * Tested positive for SARS-CoV-2 \<72 hours prior to enrolment * Predicted to have high chance of mortality: Group 1: Severe disease, defined by one or more of the following: * Dyspnea * Respiratory frequency ≥ 30/min * Blood oxygen saturation ≤ 93% * Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300 * Lung infiltrates \> 50% within 24 to 48 hours * Respiratory failure * Septic shock * Multiple organ dysfunction or failure Group 2: Mild to moderate disease, at high risk of progression to severe disease. For example, * Age \> 65 years * Chronic health conditions such as chronic lung disease, cardiovascular disease, diabetes mellitus, obesity, end-stage renal disease or liver disease Exclusion Criteria: * Rapidly progressive disease with anticipated life-expectancy \<72 hours * Receiving steroid (\>0.5mg/kg methylprednisolone equivalent) * Pregnancy * Breastfeeding

Locations (5)

Changi General Hospital

Singapore, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

Outcomes

Primary Outcomes

Dose-Limiting Toxicities

Dose-limiting toxicities are defined as \>Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively.

Time frame: till Day 28 after infusion of SARS-CoV-2 specific T cells

Secondary Outcomes

National Early Warning Score (NEWS)

Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells

Time frame: one month

Time to improvement by one category on a WHO ordinal scale

Measured by time-to-improvement by one category on a WHO ordinal scale after infusion of SARS-CoV-2 specific T cells

Time frame: one month

Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells

Measured by time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells

Time frame: two months

Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation

Measured by the duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood

Time frame: two months

Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion

Measured by the time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion

Time frame: two months

Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells

Measured by the proportion of recipients surviving at 3 months after infusion of SARS-CoV-2 specific T cells

Central Contacts

Michaela Seng

CONTACT

82487085 bmtct@kkh.com.sg

Data from ClinicalTrials.gov

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