protocolSection identificationModule nctId: NCT06378190, orgStudyIdInfo id: TranspoCART19, briefTitle: Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology, acronym: TranspoCART19, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Biomédica de Salamanca, class: OTHER, collaborators name: Spanish Clinical Research Network - SCReN, collaborators name: Fundación Canaria de Investigación Sanitaria, collaborators name: Fundación para la Investigación Biomédica del Hospital 12 de Octubre, descriptionModule briefSummary: The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months., conditionsModule conditions: Refractory B-Cell Lymphoma, conditions: B-cell Lymphoma Recurrent, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Phase I/II, pilot, open, national, prospective, multicentre, non-randomised, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: CAR-T cells therapy, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD), primaryOutcomes measure: Efficiency, secondaryOutcomes measure: Procedure-related mortality (PRM), secondaryOutcomes measure: Toxicity assessment, secondaryOutcomes measure: Response (overall and complete), secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Perceived general well-being, otherOutcomes measure: Molecular and cell biology exploratory objectives: Response dynamics, otherOutcomes measure: Molecular and cell biology exploratory objectives: Response dynamics, otherOutcomes measure: Molecular and cell biology exploratory objectives: Response dynamics, otherOutcomes measure: Molecular and cell biology exploratory objectives: In vivo survival of TranspoCART19 cells in peripheral blood, otherOutcomes measure: Molecular and cell biology exploratory objectives: Analysis of molecular markers which are possibly related to the tumor response to TranspoCART19 cells, otherOutcomes measure: Molecular and cell biology exploratory objectives: Evaluation of serum biomarkers of toxicity induced by TranspoCART19 cells (cytokine release syndrome and neurotoxicity), otherOutcomes measure: Molecular and cell biology exploratory objectives: Epigenetic studies on mononuclear bone marrow cells., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut Català d'Oncologia Hospital, status: NOT_YET_RECRUITING, city: Hospitalet de Llobregat, state: Barcelona, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: Alberto Musetti, role: CONTACT, geoPoint lat: 41.35967, lon: 2.10028, locations facility: Virgen de la Arrixaca University Hospital, status: NOT_YET_RECRUITING, city: El Palmar, state: Mur, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: Joaquín Gómez-Espuch, role: CONTACT, geoPoint lat: 37.93939, lon: -1.16095, locations facility: Clínica Universidad de Navarra, status: RECRUITING, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: Carlos Grande, role: CONTACT, geoPoint lat: 42.81687, lon: -1.64323, locations facility: University Hospital of Navarra, status: NOT_YET_RECRUITING, city: Pamplona, state: Navarra, country: Spain, contacts name: Esperanza López-Franco, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: María Carmen Mateos-Rodríguez, role: CONTACT, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Hospital Clínic, status: NOT_YET_RECRUITING, city: Barcelona, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: Valentín Ortiz-Maldonado, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Fundación Jiménez Díaz Hospital, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Esperanza López-Franco, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: Javier Cornago-Navascués, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Salamanca University Health Care Complex, status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: Lucía López-Corral, PhD, role: CONTACT, geoPoint lat: 40.96882, lon: -5.66388, locations facility: Virgen del Rocio Hospital, status: NOT_YET_RECRUITING, city: Sevilla, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, contacts name: José Antonio Pérez-Simón, role: CONTACT, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False