Manufacture of Clinical T-cell Products for Future Treatment

NCT05713513 | Completed

• 1 other identifier: PB_2018-00081; am23Khanna2
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Virus-specific T Cells

Keywords

T cell immunity; adoptive T cell therapy; Good Manufacturing Practice (GMP); leukapheresis

Outcome Measures

Primary Outcomes (2)

• Leukapheresis for manufacturing of T cell products by Good Manufacturing Practice (GMP)

  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

  Purity after isolation defined as \> 40% interferon-gamma positive cells

  one time assessment during the procedure

Interventions

Leukapheresis OTHER

Leukapheresis to isolate 1x10e9 cells, examined for purity and specificity under Good Manufacturing Practice (GMP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Departement Infektiologie & Spitalhygiene

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Leukapheresis

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Nina Khanna, Prof. Dr. med.

  University Hospital Basel, Departement Infektiologie & Spitalhygiene

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 6, 2023
• Study Start: July 24, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

CH (1)