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
Overview
- Phase
- Phase 1
- Intervention
- human SARS-CoV 2 specific T lymphocytes
- Conditions
- Moderate COVID-19-infection
- Sponsor
- Universitätsklinikum Köln
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Phase I: Dose-limiting toxicities
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or above
- •Written informed consent from the trial subject has been obtained
- •Willing to follow contraception guidelines
- •Tested positive for SARS-CoV-2 by PCR \<72 hours after swab
- •A maximum of 14 days between onset of symptoms and enrollment
- •WHO score 5 OR
- •WHO score 4 with at least one additional risk factor for disease progression
- •Acceptable risk factors are:
- •Radiographically proven lung infiltrates
- •Immunosuppression either by malignant disease or it's treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression
Exclusion Criteria
- Not provided
Arms & Interventions
Dose escalation
SARS CoV-2 infected participants will receive a single infusion over 15 to 30 minutes
Intervention: human SARS-CoV 2 specific T lymphocytes
Outcomes
Primary Outcomes
Phase I: Dose-limiting toxicities
Time Frame: 28 days
Dose-limiting toxicities until Day 28 after infusion of SARS-CoV-2- specific T cells
Secondary Outcomes
- Phase I: Clinical status(100 days after enrollment)
- Phase I: Hospitalization(100 days after enrollment)
- Phase I: SARS-CoV-2 PCR positivity(100 days after enrollment)
- Phase I: viral shedding in nasooropharyngeal swabs(100 days after enrollment)
- Phase I: Safety(3 Month)
- Phase I: Acute graft- vs. -host disease(100 days after enrollment)
- Phase I: Detection of viable human SARS-CoV-2-specific T lymphocyte(100 days after enrollment)