[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624236":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":11,"id":22,"slug":23,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":27,"acronym":28,"eligibilityCriteria":29,"healthyVolunteers":24,"sex":30,"minAge":31,"maxAge":11,"enrollmentInfo":32,"targetDuration":11,"studyType":35,"phases":36,"briefSummary":38,"conditions":39,"keywords":11,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":11},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CM336","EXPERIMENTAL",null,[13],"Biological: CM336 (BCMA\u002FCD3 bispecific antibody)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","CM336 (BCMA\u002FCD3 bispecific antibody)","CM336 is a BCMA × CD3 bispecific antibody.",[9],{"type":21,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624236","phase-1-bcmacd3-bispecific-antibody-as-bridging-therapy-before-car-t-cell-infusion-in-rrmm-100624236",false,"NCT07407010","BCMA\u002FCD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM","A Prospective Single-Arm, Single-Center Study of BCMA\u002FCD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in Relapsed or Refractory Multiple Myeloma","CM336-001","Inclusion Criteria:\n\n* 1.Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).2.Age ≥18 years.3.Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).4.Relapsed\u002FRefractory MM (RRMM) meeting one of the following:Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.Secondary plasma cell leukemia (sPCL):MM diagnosis per Chinese Guidelines (2022), plusPeripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells \\>2×10⁹\u002FL.5.Successful apheresis for CAR-T cell manufacturing.6.ECOG performance status ≤3.7.No active infections:HBV-DNA negative, HCV-RNA negative, HIV negative.8.Liver function:Total bilirubin \\\u003C1.5×ULN (\\\u003C3×ULN for Gilbert's syndrome).AST\u002FALT \\\u003C3×ULN.9.Renal function: Calculated CrCl ≥30 mL\u002Fmin (Cockcroft-Gault formula).10.Baseline oxygen saturation \\>92% (room air).11.Hematologic criteria (within 7 days of screening):WBC ≥1.0×10⁹\u002FL, ANC ≥1.0×10⁹\u002FL, hemoglobin ≥70 g\u002FL, andPlatelets ≥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).13.Reproductive requirements:Non-childbearing women eligible;Childbearing potential women: Negative serum\u002Furine pregnancy test (β-hCG) at screening.14.Contraception:Males\u002Ffemales of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.16.Compliance: Willing and able to complete study procedures and follow-up.\n\nExclusion Criteria:\n\n* 1.Prior GPRC5D-targeted immunotherapy.2.Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).3.Grade \\>2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).4.Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.5.Initiation of bridging therapy for BCMA CAR-T cell treatment.6.Unstable\u002Factive cardiovascular or cerebrovascular disease, including any of:a. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.b. Uncontrolled hypertension (\\>140\u002F90 mmHg with historical readings \\>180\u002F100 mmHg within 6 months).c. Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB\u002FRBBB).d. LVEF \\\u003C40% by echocardiography.e. Stroke or intracranial hemorrhage within 12 months before screening.f. Pre-treatment severe thrombotic events.7.Active HIV infection or seropositivity.8.Active HBV\u002FHCV infection:HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).HCV: HCV Ab(+) requires negative HCV-RNA PCR.9.Pregnancy or lactation.10.Active gastrointestinal disorders affecting swallowing or drug absorption.11.Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty\u002Fvertebroplasty; allowed: local anesthesia procedures).12.Live vaccines within 4 weeks before first study dose.13.Active psychiatric\u002Fmedical conditions impairing compliance\u002Fconsent capacity per investigator judgment.14.Contraindications to required concomitant medications\u002Fsupportive care.15.Any condition interfering with study procedures.16.Inability\u002Funwillingness to comply with protocol.","ALL","18 Years",{"count":33,"type":34},10,"ESTIMATED","INTERVENTIONAL",[37],"PHASE1","This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA\u002FCD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed\u002Frefractory multiple myeloma (RRMM).",[40],"Relapsed Refractory Multiple Myeloma (RRMM)","NOT_YET_RECRUITING","2026-02-06",{"date":44,"type":45},"2026-02-12","ACTUAL",{"date":47,"type":34},"2026-06-01",{"date":49,"type":34},"2028-05-31",{"name":5,"class":6}]