[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658419":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":51,"overallOfficials":37,"centralContacts":57,"locations":67,"responsibleParty":82,"collaborators":37,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":37,"enrollmentInfo":94,"targetDuration":37,"studyType":97,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":116,"whyStopped":37,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Centre Henri Becquerel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Longitudinal CAR-positive and CAR-negative T-cell phenotype and T-cell receptor clonality associated with Month 1 response","Longitudinal characterisation of expansion and decline kinetics, activation, differentiation and exhaustion profiles, and T-cell receptor repertoire diversity, clonality and persistence by spectral flow cytometry and sequencing. Parameters will be compared between responders and non-responders at Month 1 using Lugano 2014 criteria for B-cell lymphomas or International Myeloma Working Group criteria for multiple myeloma.","Apheresis; CAR-T product before infusion; Day 7 after infusion ; Month 1 after infusion. Therapeutic response is assessed at Month 1.",[14,18,22,26,30,33],{"measure":15,"description":16,"timeFrame":17},"Secondary imaging outcomes after CAR-T cell infusion","Measures include Month 3 disease response PET-derived tumour burden","Month 3 after CAR-T cell infusion",{"measure":19,"description":20,"timeFrame":21},"Secondary clinical outcomes after CAR-T cell infusion","12-month progression-free survival, overall survival and non-relapse mortality (in months)","Month 12 after CAR-T cell infusion",{"measure":23,"description":24,"timeFrame":25},"Bridge treatment received","name of bridge treatment received before CAR-T cell infusion","Month 1 after inclusion",{"measure":27,"description":28,"timeFrame":29},"secondary immunological outcome after CAR-T cell infusion","CAR-T expansion and persistence","Month 1 after CAR-T cell infusion",{"measure":31,"description":32,"timeFrame":17},"Secondary micobiota outcome","gut microbiota findings",{"measure":34,"description":35,"timeFrame":36},"Secondary molecular outcome","Tumour molecular findings","Inclusion",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","CARBIOM will enroll up to 45 participants to obtain 40 reinfused and evaluable participants at Month 1: 20 with B-cell lymphoma and 20 with multiple myeloma. CAR-T treatment and all disease-directed care remain standard of care and are not assigned by the study. Research procedures consist mainly of protocol-specific blood and stool sampling and laboratory analyses.\n\nThe primary analysis will longitudinally characterize CAR-positive and CAR-negative T-cell subpopulations, including expansion and decline, activation, differentiation, exhaustion, and T-cell receptor repertoire diversity, clonality and persistence. Analyses will use spectral flow cytometry and sequencing at apheresis, in the CAR-T bag before infusion, at Day 7 +\u002F- 3 days and at Month 1 +\u002F- 7 days. These parameters will be compared according to Month 1 response assessed using Lugano 2014 criteria for B-cell lymphomas or International Myeloma Working Group criteria for multiple myeloma.\n\nSecondary and exploratory analyses will describe Month 3 response; 12-month progression-free survival, overall survival and non-relapse mortality; bridging therapy; CAR-T expansion and persistence by routine flow cytometry and digital PCR; cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and prolonged cytopenias; PET-derived tumour burden; apheresis and CAR-T product features; tumour genomics, clonal haematopoiesis, antibiotic exposure and gut microbiota; and will establish a biobank of frozen cells, RNA and DNA for future ancillary analyses.",[46],{"label":47,"type":6,"description":48,"interventionNames":49},"CARBIOM cohort","Adults receiving standard-of-care anti-CD19 or anti-BCMA CAR-T cell therapy undergo protocol-specific biological sampling and longitudinal immunomonitoring. CAR-T treatment is not assigned by the study.",[50],"Procedure: Biological sample collection and immunomonitoring",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":37},"PROCEDURE","Biological sample collection and immunomonitoring","Additional blood samples are collected at protocol-defined time points around standard-of-care CAR-T therapy, and stool samples are collected before lymphodepletion, at Month 1 and at Month 3. Analyses include spectral flow cytometry, T-cell receptor repertoire sequencing, routine flow cytometry, digital PCR, tumour molecular profiling and gut microbiota analyses. Standard-of-care CAR-T treatment is not assigned by the study.",[47],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":37,"email":62},"Vincent Camus, MD, PhD","CONTACT","+33 2 32 08 29 47","vincent.camus@chb.unicancer.fr",{"name":64,"role":60,"phone":65,"phoneExt":37,"email":66},"Doriane Richard, PhD","+33 2 32 08 29 85","Doriane.richard@chb.unicancer.fr",[68],{"facility":5,"status":37,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Rouen","Normandy","76038","France","FR",{"type":75,"coordinates":76},"Point",[77,78],1.09932,49.44313,{"lat":78,"lon":77},[81],{"name":59,"role":60,"phone":61,"phoneExt":37,"email":62},{"type":83,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100658419","immunomonitoring-and-predictive-biomarkers-after-car-t-cell-therapy-in-b-cell-lymphoma-and-multiple-myeloma-100658419",false,"NCT07852377","Immunomonitoring and Predictive Biomarkers After CAR-T Cell Therapy in B-Cell Lymphoma and Multiple Myeloma","Immunomonitoring and Identification of Predictive Biomarkers of Response, Toxicity and Risk of Relapse After CAR-T Cells in B-cell Lymphomas and Multiple Myeloma","CARBIOM","Inclusion Criteria:\n\n* Age 18 years or older.\n* Relapsed or refractory B-cell lymphoma or multiple myeloma.\n* Indication for anti-CD19 or anti-BCMA CAR-T cell treatment.\n* Signed informed consent.\n* Affiliation to or beneficiary status under a health insurance scheme.\n\nExclusion Criteria:\n\n* Previous exposure to anti-BCMA bispecific antibodies or need for anti-BCMA bispecific antibodies as bridging therapy before anti-BCMA CAR-T cell administration.\n* Pregnant or breastfeeding.\n* Absence of informed consent.\n* Primary central nervous system lymphoma or primary vitreoretinal lymphoma.\n* Body weight below 30 kg.\n* Protected adult or person deprived of liberty under guardianship or curatorship.\n* Inability to understand the study or comply with study constraints for language, psychological, geographical or other reasons.","ALL","18 Years",{"count":95,"type":96},45,"ESTIMATED","INTERVENTIONAL",[39],"CARBIOM is a single-centre, non-randomized interventional study involving additional biological sampling with minimal risks and constraints. Up to 45 adults with relapsed or refractory B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care anti-CD19 or anti-BCMA CAR-T cells will be enrolled. The study will characterize CAR-positive and endogenous CAR-negative T-cell populations and T-cell receptor clonality at apheresis, in the CAR-T product, at Day 7 +\u002F- 3 days and at Month 1 +\u002F- 7 days. These findings will be related to treatment response, toxicities and relapse during 12 months of follow-up. The study hypothesis is that dynamic immunological and molecular characteristics measured along the CAR-T pathway are associated with early response, toxicity and relapse risk.",[101,102],"B Cell Lymphoma","Multiple Mieloma",[104,105,106,107,108,109,110,111,112,113,114,115],"chimeric antigen receptor t-cell therapy","relapsed or refractory B-cell lymphoma","relapsed or refractory multiple mieloma","immunomonitoring","T-cell receptor repertoire","spectral flow cytometry","predictive biomarkers","treatment response","toxicity","relapse","gut microbiota","clonal haematopoiesis","NOT_YET_RECRUITING","2026-09-30",{"date":119,"type":120},"2026-10-01","ACTUAL",{"date":122,"type":96},"2026-09-18",{"date":124,"type":96},"2028-11-02",{"name":5,"class":6},1]