[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501232":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":28,"responsibleParty":46,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Relma-cel secondary infusion","EXPERIMENTAL",null,[13],"Drug: Relma-cel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],[21],"JWCAR029",[23],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Weili Zhao, professor","CONTACT","+86 021-64370045","zwl_trial@163.com",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"NO.197， Ruijin Er Road","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":38,"coordinates":39},"Point",[40,41],121.45806,31.22222,{"lat":41,"lon":40},[44],{"name":45,"role":25,"phone":26,"phoneExt":11,"email":27},"Weili Zhao, doctorate",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Vice president，Ruijin hospital","100501232","phase-4-secondary-infusion-of-relma-cel-injection-for-relapsed-or-refractory-b-cell-lymphoma-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":60,"type":61},8,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.",[67],"Relapsed or Refractory B-cell Lymphoma","2024-10-21",{"date":70,"type":71},"2024-10-23","ACTUAL",{"date":73,"type":71},"2023-05-01",{"date":75,"type":61},"2027-12-31",{"name":5,"class":6},1]