[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607201":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":19,"collaborators":11,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":25,"acronym":9,"eligibilityCriteria":26,"healthyVolunteers":23,"sex":27,"minAge":28,"maxAge":11,"enrollmentInfo":29,"targetDuration":11,"studyType":32,"phases":33,"briefSummary":35,"conditions":36,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":44,"leadSponsor":46,"locationsCount":11},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"QLS32015","EXPERIMENTAL",null,[13],"Biological: QLS32015",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","QLS32015 is a GPRC5D × CD3 bispecific antibody.",[9],{"type":20,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607201","early-phase-1-a-single-arm-single-center-trial-of-bridging-gprc5dcd3-bispecific-antibody-treatment-with-bcma-car-t-cell-therapy-for-relapsedrefractory-multiple-myeloma-100607201",false,"NCT07185477","A Single-arm Single-center Trial of Bridging GPRC5D\u002FCD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).\n2. Age ≥18 years.\n3. Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).\n4. Relapsed\u002FRefractory MM (RRMM) meeting one of the following:\n\n   Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.\n\n   Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.\n\n   Secondary plasma cell leukemia (sPCL):\n\n   MM diagnosis per Chinese Guidelines (2022), plus Peripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells \\>2×10⁹\u002FL.\n5. Successful apheresis for CAR-T cell manufacturing.\n6. ECOG performance status ≤3.\n7. No active infections:\n\n   HBV-DNA negative, HCV-RNA negative, HIV negative.\n8. Liver function:\n\n   Total bilirubin \\\u003C1.5×ULN (\\\u003C3×ULN for Gilbert's syndrome). AST\u002FALT \\\u003C3×ULN.\n9. Renal function: Calculated CrCl ≥30 mL\u002Fmin (Cockcroft-Gault formula).\n10. Baseline oxygen saturation \\>92% (room air).\n11. Hematologic criteria (within 7 days of screening):\n\nWBC ≥1.0×10⁹\u002FL, ANC ≥1.0×10⁹\u002FL, hemoglobin ≥70 g\u002FL, and Platelets ≥75×10⁹\u002FL (or ≥50×10⁹\u002FL if bone marrow plasma cells ≥50%). Investigator discretion permitted for clinical justification. 12.Growth factor restrictions: 2-week washout required for erythropoietin, G-CSF, GM-CSF, or thrombopoietin agonists (e.g., eltrombopag).\n\n13.Reproductive requirements: Non-childbearing women eligible; Childbearing potential women: Negative serum\u002Furine pregnancy test (β-hCG) at screening.\n\n14.Contraception: Males\u002Ffemales of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.\n\n15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.\n\n16.Compliance: Willing and able to complete study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Prior GPRC5D-targeted immunotherapy.\n2. Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).\n3. Grade \\>2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).\n4. Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.\n5. Initiation of bridging therapy for BCMA CAR-T cell treatment.\n6. Unstable\u002Factive cardiovascular or cerebrovascular disease, including any of:\n\n   1. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.\n   2. Uncontrolled hypertension (\\>140\u002F90 mmHg with historical readings \\>180\u002F100 mmHg within 6 months).\n   3. Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB\u002FRBBB).\n   4. LVEF \\\u003C40% by echocardiography.\n   5. Stroke or intracranial hemorrhage within 12 months before screening.\n   6. Pre-treatment severe thrombotic events.\n7. Active HIV infection or seropositivity.\n8. Active HBV\u002FHCV infection:\n\n   HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).\n\n   HCV: HCV Ab(+) requires negative HCV-RNA PCR.\n9. Pregnancy or lactation.\n10. Active gastrointestinal disorders affecting swallowing or drug absorption.\n11. Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty\u002Fvertebroplasty; allowed: local anesthesia procedures).\n12. Live vaccines within 4 weeks before first study dose.\n13. Active psychiatric\u002Fmedical conditions impairing compliance\u002Fconsent capacity per investigator judgment.\n14. Contraindications to required concomitant medications\u002Fsupportive care.\n15. Any condition interfering with study procedures.\n16. Inability\u002Funwillingness to comply with protocol.","ALL","18 Years",{"count":30,"type":31},20,"ESTIMATED","INTERVENTIONAL",[34],"EARLY_PHASE1","This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of GPRC5D\u002FCD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed\u002Frefractory multiple myeloma (RRMM).",[37],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)","NOT_YET_RECRUITING","2025-09-15",{"date":41,"type":42},"2025-09-22","ACTUAL",{"date":39,"type":31},{"date":45,"type":31},"2028-05-31",{"name":5,"class":6}]