Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02007356
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2013-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000257', 'term': 'Adenoviridae Infections'}, {'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of enriched IFN-γ+ T-cells', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Treatment efficacy', 'timeFrame': '7 days', 'description': 'Treatment efficacy defined as reduction of virus load, in vivo expansion of antigen-specific T cells in peripheral blood as well as reduction of clinical signs of specific viral infection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adenovirus Infection', 'EBV', 'Cytomegalovirus Infections', 'Cytokine Capture System', 'Allogenic Disease']}, 'referencesModule': {'references': [{'pmid': '15134189', 'type': 'BACKGROUND', 'citation': 'Kaufmann GR, Khanna N, Weber R, Perrin L, Furrer H, Cavassini M, Ledergerber B, Vernazza P, Bernasconi E, Rickenbach M, Hirschel B, Battegay M; Swiss HIV Cohort Study. Long-term virological response to multiple sequential regimens of highly active antiretroviral therapy for HIV infection. Antivir Ther. 2004 Apr;9(2):263-74.'}]}, 'descriptionModule': {'briefSummary': 'To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\> 18 years of age\n* Undergone allogeneic HSCT\n* Written informed consent\n* Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:\n\nPatient with Adenovirus Infection:\n\n1. Antiviral treatment with cidofovir for at least 7 days\n\n * no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or\n * cluster of differentiation 3 (CD3) + cells \\< 300/µL on treatment for at least 7 days\n2. Or if antiviral treatment is contraindicated\n\nPatient with EBV:\n\n1\\. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg/m2)\n\n* No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or\n* CD3+ cells \\< 300/µL 7 days after receipt of treatment or\n* Clinical progression\n\nPatient with CMV:\n\n1. Antiviral treatment with ganciclovir or foscavir for 14 days\n\n \\- No Virus load decrease (≤ 1 log) or virus load increase on day 14\n2. Or if \\> 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells \\< 300/µL\n3. Or if antiviral treatment is contraindicated -\n\nPatient Exclusion Criteria:\n\n* graft-versus-host disease (GVHD) \\> grade 2 at the time point of planned infusion\n* Known allergy to iron-dextran or murine antibodies'}, 'identificationModule': {'nctId': 'NCT02007356', 'acronym': 'CCS', 'briefTitle': 'A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'A Phase I/II Single-center Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®', 'orgStudyIdInfo': {'id': 'EKBB 205/13; me12Khanna'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'allogeneic HSCT', 'description': 'The present study will evaluate and validate in a single-center, open-label, single arm fashion the safety and feasibility of direct infusions of donor-derived pathogen-specific IFN-γ positive T-cells in recipients of HSCT with post-transplant viral infection according to the previously clinically certified CCS® \\[3-6\\]. The Investigator will first generate and apply IFN-γ positive selected T-cells to recipients of HSCT with CMV, EBV or adenovirus as previously published. The Investigator aim is to include 6 patients from the University Hospital of Basel.\n\nWith confirmed safety the investigator will in the future perform an efficacy study and extend this treat-ment for other clinically relevant pathogens including human herpesvirus (HHV)-6, HHV-8, polyomaviruses JC and BK and fungi including Aspergillus fumigatus and Candida albicans, to other immunosuppressed patients such as solid organ transplant (SOT) recipients.', 'interventionNames': ['Biological: IFN-γ positive selected T-cells']}], 'interventions': [{'name': 'IFN-γ positive selected T-cells', 'type': 'BIOLOGICAL', 'armGroupLabels': ['allogeneic HSCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nina Khanna, Dr.', 'role': 'CONTACT', 'email': 'nina.khanna@usb.ch', 'phone': '0041-61-', 'phoneExt': '7325'}, {'name': 'Nina Khanna, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Nina Khanna, MD', 'role': 'CONTACT', 'email': 'nina.khanna@usb.ch', 'phone': '+41-61-2652525 (Zentrale)'}], 'overallOfficials': [{'name': 'Nina Khanna, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsspital Basel, Klinik für Infektiologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}