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Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT04762186•Universitätsklinikum Köln

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Exclusion Criteria

•Participation in any other clinical trial of an experimental agent treatment
•Active GvHD or history of GvHD
•History of CAR-T-Cell Therapy
•COVID-19 WHO ordinal scale ≥6
•Anticipated life-expectancy \<72 hours
•Expected duration of hospital stay \<72 hours
•Sepsis-induced leukopenia or thrombocytopenia (leukocytes \<1,000/µl or platelets \<50,000/µl). If the cytopenias result from underlying hematologic disease or its treatment this will not be regarded as exclusion criterion
•CT pneumonia score ≥13 \[50\]
•Any Steroids ≥1 mg/kg Prednisolon-equivalent/kg BW, besides 6 mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19
•Pregnant or breast feeding
+19 more criteria

Locations (1)

Department I for Internal Medicine University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Key Dates

Start Date

December 8, 2021

Primary Completion Date

August 3, 2022

Completion Date

August 3, 2022

Last Updated

September 15, 2022

Enrollment

ACTUAL participants

Conditions

Moderate COVID-19-infection

Interventions

human SARS-CoV 2 specific T lymphocytes

DRUG