[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601147":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":33,"locations":39,"responsibleParty":57,"collaborators":22,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":22,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":42,"whyStopped":22,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ASCT Combined With BCMA CAR-T and GPRC5D\u002FCD3 BiTEs Maintenance","EXPERIMENTAL","Patients will undergo ASCT followed by BCMA CAR-T infusion. Three month after CAR-T cell infusion, patients will begin GPRC5D\u002FCD3 BiTEs maintenance therapy for ≥2 years.",[13,14,15],"Procedure: Autologous Hematopoietic Stem Cell Transplantation","Biological: BCMA CAR-T","Drug: GPRC5D\u002FCD3 BiTEs",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Autologous Hematopoietic Stem Cell Transplantation","Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"BIOLOGICAL","BCMA CAR-T","Patients will receive BCMA CAR-T single dose (3.0 x 10\\^6 cells \u002Fkg) infusion 3 days after ASCT.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"DRUG","GPRC5D\u002FCD3 BiTEs","Patients will receive GPRC5D\u002FCD3 BiTEs maintenance therapy at a dose of 54 μg\u002Fkg every 4 weeks, starting 3 months after BCMA CAR-T infusion and continuing for at least 2 years",[9],[34],{"name":35,"role":36,"phone":37,"phoneExt":22,"email":38},"Gang An, PhD&MD","CONTACT","86-022-23909171","angang@ihcams.ac.cn",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":49,"coordinates":50},"Point",[51,52],117.17667,39.14222,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":37,"phoneExt":22,"email":38},"Gang An",{"type":58,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100601147","phase-2-asct-combined-with-bcma-car-t-and-gprc5dcd3-bites-maintenance-for-transplant-eligible-ultra-high-risk-multiple-myeloma-100601147",false,"NCT07106710","ASCT Combined With BCMA CAR-T and GPRC5D\u002FCD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma","A Prospective, Single-Arm, Phase II Study of Autologous Stem Cell Transplantation Combined With BCMA CAR-T Therapy Followed by GPRC5D\u002FCD3 Bispecific Antibody Maintenance in Transplant-Eligible Patients With Ultra-High-Risk Multiple Myeloma","CAREMM-005","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 70 years.\n2. Participants with documented newly-diagnosed multiple myeloma according to IMWG diagnostic criteria.\n3. Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg\u002FdL and abnormal serum Ig kappa lambda FLC ratio.\n4. Patients deemed eligible for high-dose chemotherapy with ASCT.\n5. Presence of at least one of the following ultra-high-risk features: a. Double-hit multiple myeloma, defined as the presence of at least two of the following high-risk cytogenetic abnormalities: t(4;14), t(14;16), deletion 1p, gain 1q, MYC rearrangement, deletion 17p, or TP53 mutation; b. Presence of extramedullary soft tissue plasmacytomas; c. Circulating plasma cells ≥2% in peripheral blood.\n6. Tumor cells were BCMA and GPRC5D positive.\n7. Serum total bilirubin \\\u003C2 x upper limit of normal (ULN), serum AST and ALT \\\u003C3 x ULN, creatinine clearance ≥ 30mL\u002Fmin (Cockroft-Gault formula).\n8. Informed Consent\u002FAssent: All subjects have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Active amyloidosis.\n2. Central nervous system involvement.\n3. Prior BCMA-targeted therapy or CAR-T therapy.\n4. Active hepatitis B or hepatitis C virus infection.\n5. Known HIV infection.\n6. Life expectancy \\\u003C6 months.\n7. Woman who are pregnant or breastfeeding.\n8. Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.\n9. Any other conditions that are not eligible for the trial in the judgement of the principal investigator.","ALL","18 Years","70 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D\u002FCD3 bispecific antibody maintenance in transplant-eligible patients with ultra-high-risk multiple myeloma.",[78],"Multiple Myeloma, Newly Diagnosed",[80,81,82,83,84],"Multiple myeloma","Ultra-high-risk","CAR-T","BiTEs","ASCT","2025-07-30",{"date":87,"type":88},"2025-08-06","ACTUAL",{"date":90,"type":72},"2025-08-10",{"date":92,"type":72},"2028-08-01",{"name":5,"class":6},1]