[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501232":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":27,"overallOfficials":13,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":13,"id":63,"slug":13,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":13,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":13,"enrollmentInfo":71,"targetDuration":13,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":13,"overallStatus":44,"whyStopped":13,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate","ORR is defined as the percentage of participants achieving either CR or partial response (PR) per the Lugano Classification as determined by study investigators","3 months post CAR-T infusion",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This study aims to collect efficacy and safety data from adult patients with relapsed or refractory large B-cell lymphoma (r\u002Fr LBCL) who receive a second infusion of relma-cel injection after initial treatment with relma-cel. The study will not include any form of grouping, and subgroup analysis will be conducted based on the actual data collected.",[22],{"label":23,"type":24,"description":13,"interventionNames":25},"Relma-cel secondary infusion","EXPERIMENTAL",[26],"Drug: Relma-cel",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Relma-cel","Patients who have undergone at least one disease assessment after initial Relma-cel treatment and have not achieved complete remission may receive a second treatment based on clinical practice. The specific dosage will be determined by the investigator according to the patient's condition and available dose reserves.",[23],[34],"JWCAR029",[36],{"name":37,"role":38,"phone":39,"phoneExt":13,"email":40},"Weili Zhao, professor","CONTACT","+86 021-64370045","zwl_trial@163.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"NO.197， Ruijin Er Road","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":39,"phoneExt":13,"email":40},"Weili Zhao, doctorate",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Vice president，Ruijin hospital","100501232",false,"NCT05806580","Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma","A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma","Inclusion Criteria:\n\n* Patients have signed an Informed Consent Form (ICF).\n* Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel.\n* Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second treatment (including PR\u002FPD\u002FSD) based on clinical practice.\n* Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\\^6 CAR-T cells), with specific dosage determined by the investigator based on patient condition and dose availability.\n* Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.\n* Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the second treatment.\n* Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels before retreatment.\n* Patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment.\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).\n* Patients with uncontrolled systemic fungal, bacterial, viral, or other infections","ALL","18 Years",{"count":72,"type":73},8,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.",[79],"Relapsed or Refractory B-cell Lymphoma","2024-10-21",{"date":82,"type":83},"2024-10-23","ACTUAL",{"date":85,"type":83},"2023-05-01",{"date":87,"type":73},"2027-12-31",{"name":5,"class":6},1]