Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC
The clinical trial will consist of a phase I and a phase II part. The main trial objective in the phase I part is to determine the recommended phase II dose (RP2D) of viable human SARS-CoV 2-specific T cells by evaluation of safety and tolerability. In the phase II part, the primary objective is to gain first data on efficacy of adaptive therapy with viable human SARS-CoV-2-specific T cells. This will be a randomized, prospective feasibility trial. Details to phase II will be updated after completion of phase I.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
In dose level one, SARS-CoV-2 infected patients will receive 1,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In dose level two SARS-CoV-2 infected patients will receive 5,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In parallel, all patients will receive the current SoC treatment for COVID-19.
Department I for Internal Medicine University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany
Phase I: Dose-limiting toxicities
Dose-limiting toxicities until Day 28 after infusion of SARS-CoV-2- specific T cells
Time frame: 28 days
Phase I: Safety
The rate and severity of adverse events after infusion of SARS-CoV-2 specific T cells during the trial
Time frame: 3 Month
Phase I: Acute graft- vs. -host disease
Clinical manifestations of acute graft- vs. -host disease at day 100 after randomization
Time frame: 100 days after enrollment
Phase I: Clinical status
Clinical status as assessed on the WHO ordinal scale
Time frame: 100 days after enrollment
Phase I: Hospitalization
duration in days
Time frame: 100 days after enrollment
Phase I: SARS-CoV-2 PCR positivity
Duration of SARS-CoV-2 PCR positivity (in days) from nasooropharyngeal swabs until discharge or death
Time frame: 100 days after enrollment
Phase I: Detection of viable human SARS-CoV-2-specific T lymphocyte
Detection of viable human SARS-CoV-2-specific T lymphocyte after infusion
Time frame: 100 days after enrollment
Phase I: viral shedding in nasooropharyngeal swabs
Effect of viable human SARS-CoV-2-specific T lymphocyte infusion on viral shedding in nasooropharyngeal swabs
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Time frame: 100 days after enrollment