ESPECT: Epstein-Barr Virus (EBV) specific T-cell therapy
Summary description of the study
Patients infected with Epstein-Barr Virus (EBV) can become severely ill; this includes EBV-induced cancers such as lymphomas. There are generally few effective therapies for treating EBV-associated diseases, representing an area of significant medical need. In some patients who respond inadequately to approved chemotherapies or antibody therapies, new findings show that virus-specific defense cells are effective. In this study, virus-specific defense cells are obtained from the blood of a compatible donor, processed in the laboratory, and then administered to patients at three time points via infusion. The cells are processed to specifically attack only the infected (cancer) cells without harming healthy cells.
(BASEC)
Intervention under investigation
Either blood is drawn from the patient themselves, or a compatible donor can donate blood. From this blood, the appropriate cells are isolated and expanded in the laboratory for 10 days and modified to fight the EBV-infected cells. This modification is carried out under strict regulations. Once the right cells have multiplied sufficiently, they are administered to the recipient via infusions.
(BASEC)
Disease under investigation
EBV-associated diseases/Lymphomas
(BASEC)
Group A: Patients with EBV-related lymphomas with EBV complications or patients with primary immunodeficiency diseases at high risk for EBV complications with planned cell transplantation from an unrelated donor Group B: EBV-related PTLD developing after HCT or SOT For both groups: - All age groups - Negative pregnancy test in female patients of childbearing age. - Signed written informed consent from the patient and/or parents/legal representatives (BASEC)
Exclusion criteria
- Patients who received antithymocyte globulin or Campath within 28 days prior to infusion - Patients with active, acute graft versus host disease grade III-IV - Previous severe reaction to DMSO (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Universitättspital Basel, Klinik für Infektiologie
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Nina Khanna
+41 61 265 31 98
nina.khanna@clutterusb.chUniversitätsspital Basel, Klinik für Infektiologie Petersgraben 4 4031 Basel
(BASEC)
General Information
Klinik f?r Infektiologie und Spitalhygiene, University Hospital of Basel,
+41 61 328 73 25
nina.khanna@clutterusb.ch(ICTRP)
General Information
Klinik fr Infektiologie und Spitalhygiene, University Hospital of Basel
+41 61 328 73 25
nina.khanna@clutterusb.ch(ICTRP)
Scientific Information
Klinik f?r Infektiologie und Spitalhygiene, University Hospital of Basel,
+41 61 328 73 25
nina.khanna@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
20.03.2023
(BASEC)
ICTRP Trial ID
NCT05688241 (ICTRP)
Official title (approved by ethics committee)
Epstein-Barr Virus-specific T Memory Stem Cell Therapy to Treat EBV-driven Lymphomas/Diseases (BASEC)
Academic title
Epstein-Barr Virus (EBV) -Specific T Memory Stem Cell (Tscm) Therapy to Treat EBV- Driven Lymphomas/ Diseases (ICTRP)
Public title
EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases (ICTRP)
Disease under investigation
EBV LymphomaPost-transplant Lymphoproliferative Disease (PTLD) (ICTRP)
Intervention under investigation
Drug: Donor-derived ex-vivo expanded EBV Tscm CTL (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Patients' inclusion criteria:
- Group A: Patients with EBV driven lymphomas (e.g., NK/T-cell lymphoma), with EBV
complications (e.g. HLH, CAEBV) or patients with primary immunodeficiency disorders
with high risk for EBV complications (e.g. SCID) with planned allogeneic HCT
- Group B: EBV-driven PTLD that develop after a HCT or SOT
For both groups:
- All age groups
- Negative pregnancy test in female patients of childbearing potential.
- Signed written informed consent of patient or/and parents
Patients' exclusion criteria:
- Patients receiving anti-thymocyte globulin or Campath within 28 days of infusion
- Patients with active, acute GvHD grades III-IV
- Previous severe reaction to dimethylsulfoxide (DMSO)
Donors' inclusion criteria:
- EBV positive serology (VCA and Epstein-Barr nuclear antigen (EBNA) immunoglobulin G
(IgG) positive)
- Detectable interferon (IFN)-y-secreting T cells (>100 SFC/10e6 PBMC) measured by
Elispot to the EBV consensus peptide pool
- Suitability for blood or HCT donation meeting requirements of local institutional
guidelines
- An informed consent for EBV Tscm CTL manufacturing
- Age > 18 years
Donors' exclusion criteria:
- Detectable IFN-y-secreting T-cells <100 spot-forming cell (SFC)/10e6 PBMC measured
by Elispot to EBV select
- Unwilling and/or unable to donate, according to the donor center (ICTRP)
not available
Primary and secondary end points
Assessment of feasibility to expand Tscm-enriched EBV CTLs;Safety of EBV Tscm-CTL infusion assessed by number of early infusion-related events;Safety of EBV Tscm-CTL infusion assessed by number of late clinical reaction to EBV Tscm-CTLs (ICTRP)
not available
Registration date
21.12.2022 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Nina Khanna, Prof. Dr. med.;Nina Khanna, Prof. Dr. med., nina.khanna@usb.ch, +41 61 328 73 25, Klinik f?r Infektiologie und Spitalhygiene, University Hospital of Basel, (ICTRP)
Secondary trial IDs
2022-01210, am22Khanna (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05688241 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available