Clinical trial NCT05713513: Manufacture of Clinical T-cell Products for Future Treatment
Official title: Pilot Study to Manufacture Clinical T-cell Products for Future Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Virus-specific T Cells
Keywords: T cell immunity
adoptive T cell therapy
Good Manufacturing Practice (GMP)
leukapheresis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Leukapheresis for manufacturing of T cell products by Good Manufacturing Practice (GMP)
timeFrame: one time assessment during the procedure
measure: Purity after isolation defined as > 40% interferon-gamma positive cells
timeFrame: one time assessment during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Departement Infektiologie & Spitalhygiene
Study officials:
affiliation: University Hospital Basel, Departement Infektiologie & Spitalhygiene
name: Nina Khanna, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: