Manufacture of Clinical T-cell Products for Future Treatment

February 3, 2023 updated by: University Hospital, Basel, Switzerland

Pilot Study to Manufacture Clinical T-cell Products for Future Treatment

The aim of this pilot study is to validate the manufacture of T-cell products using GMP-approved reagents for future clinical use. Lymphocytes from whole blood of max 300ml from volunteers or from total 9 volunteer apheresates will be isolated to validate the protocol under Good Manufacturing Practice (GMP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Viral diseases occur in up to 50% of patients after transplantation. In most cases, there is a reactivation of the virus, which can be found latent or dormant in the body's own cells. The main reason for the occurrence of these diseases is the limited T-cell immunity, which serves to control these viruses in healthy people. To date, there are few effective and, depending on the virus, no established therapies. In addition, the established therapies are often associated with considerable toxicity. An alternative therapy, which has already shown success in the 1990s, is the administration of virus-specific T cells. Adoptive T cell therapies for the major pathogens emerging post-transplant are intended to use. In order to be used as therapy these cells must be manufactured under Good Manufacturing Practice (GMP). Leukapheresis from whole blood of maximum 300ml is used to generate the virus-specific T cells. These cells are examined for purity and specificity and are used for scientific purposes only. The aim of this study is to validate the manufacture of T-cell products using GMP-approved reagents for future clinical use.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel, Departement Infektiologie & Spitalhygiene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The probands are selected on a voluntary basis. They are not directly involved in the project and take part in the study voluntarily. They either come from other working groups in the Department of Biomedicine or from the University Hospital Basel.

Description

Inclusion Criteria:

  • signed informed consent
  • Immunoglobulins (Ig) G available for Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
  • Detectable T-cell response for EBV or CMV measured by flow cytometry (> 0.01%)

Exclusion Criteria:

  • Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human T-cell lymphoma virus (HTLV)-I/II

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukapheresis for manufacturing of T cell products by Good Manufacturing Practice (GMP)
Time Frame: one time assessment during the procedure
Number of leukapheresis to isolate 1x10e9 cells for manufacturing of T cell products by Good Manufacturing Practice (GMP)
one time assessment during the procedure
Purity after isolation defined as > 40% interferon-gamma positive cells
Time Frame: one time assessment during the procedure
Purity after isolation defined as > 40% interferon-gamma positive cells
one time assessment during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Nina Khanna, Prof. Dr. med., University Hospital Basel, Departement Infektiologie & Spitalhygiene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 24, 2019

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PB_2018-00081; am23Khanna2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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