Virus-specific T CellsNCT05713513
Manufacture of Clinical T-cell Products for Future Treatment
An observational study of Virus-specific T Cells, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virus-specific T Cells
- What is being tested?
- Leukapheresis
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jul 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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%)
Who cannot join
- Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human T-cell lymphoma virus (HTLV)-I/II
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Departement Infektiologie & Spitalhygiene
Basel, 4031
About this study
Official title: 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).
Read the 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.
- Conditions
- Virus-specific T Cells
- Being tested
- Leukapheresis
- Keywords
- T cell immunity, adoptive T cell therapy, Good Manufacturing Practice (GMP), leukapheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeukapheresisOther
Leukapheresis to isolate 1x10e9 cells, examined for purity and specificity under Good Manufacturing Practice (GMP)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: one time assessment during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start24 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus-specific T CellsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Khanna, Prof. Dr. med., Principal investigator, University Hospital Basel, Departement Infektiologie & Spitalhygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713513
- Sponsor's protocol ID
- PB_2018-00081; am23Khanna2
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Manufacture Clinical T-cell Products for Future Treatment
- ClinicalTrials.gov ID
- NCT05713513
- Acronym / sponsor ID
- PB_2018-00081; am23Khanna2
- Conditions
- Virus-specific T Cells
- Keywords
- T cell immunity, adoptive T cell therapy, Good Manufacturing Practice (GMP), leukapheresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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%)
Key exclusion criteria (1 listed)
- Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human T-cell lymphoma virus (HTLV)-I/II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeukapheresisLeukapheresis to isolate 1x10e9 cells, examined for purity and specificity under Good Manufacturing Practice (GMP) | Other | – |
Primary outcome
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Khanna, Prof. Dr. med. principal investigator
University Hospital Basel, Departement Infektiologie & Spitalhygiene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virus-specific T Cells, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukapheresis for manufacturing of T cell products by Good Manufacturing Practice (GMP) (time frame: one time assessment during the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.