ESPECT: Epstein-Barr Virus (EBV) specific T-cell therapy
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
- 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)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Universitättspital Basel, Klinik für Infektiologie
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Nina Khanna
+41 61 265 31 98
nina.khanna@clutterusb.chUniversitätsspital Basel, Klinik für Infektiologie Petersgraben 4 4031 Basel
(BASEC)
Informations générales
Klinik f?r Infektiologie und Spitalhygiene, University Hospital of Basel,
+41 61 328 73 25
nina.khanna@clutterusb.ch(ICTRP)
Informations générales
Klinik fr Infektiologie und Spitalhygiene, University Hospital of Basel
+41 61 328 73 25
nina.khanna@clutterusb.ch(ICTRP)
Informations scientifiques
Klinik f?r Infektiologie und Spitalhygiene, University Hospital of Basel,
+41 61 328 73 25
nina.khanna@clutterusb.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
20.03.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05688241 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Epstein-Barr Virus-specific T Memory Stem Cell Therapy to Treat EBV-driven Lymphomas/Diseases (BASEC)
Titre académique
Epstein-Barr Virus (EBV) -Specific T Memory Stem Cell (Tscm) Therapy to Treat EBV- Driven Lymphomas/ Diseases (ICTRP)
Titre public
EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases (ICTRP)
Maladie en cours d'investigation
EBV LymphomaPost-transplant Lymphoproliferative Disease (PTLD) (ICTRP)
Intervention étudiée
Drug: Donor-derived ex-vivo expanded EBV Tscm CTL (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
non disponible
Date d'enregistrement
21.12.2022 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
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)
ID secondaires
2022-01210, am22Khanna (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05688241 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible