NCT04762186

Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19

A Phase I/ Randomized Phase II Trial to Analyse Safety and Efficacy of Human SARS-CoV-2-specific T Lymphocyte Transfer in Patients With COVID-19 in Need of Treatment or at Risk of Severe COVID-19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Universitätsklinikum Köln · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC

Detailed description

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.

Conditions

• Moderate COVID-19-infection

Interventions

Type	Name	Description
DRUG	human SARS-CoV 2 specific T lymphocytes	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.

Timeline

• Start date: 2021-12-08
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-02-21
• Last updated: 2022-09-15

Locations

1 site across 1 country: Germany