[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643266":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":41,"collaborators":19,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":19,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":19,"enrollmentInfo":52,"targetDuration":19,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":19,"overallStatus":61,"whyStopped":19,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RN9101 injection","EXPERIMENTAL","RN9101 injection is a third-generation, non-replicative, self-inactivating lentivirus vector, which carries a CD19\u002FBCMA-targeted CAR",[13],"Drug: RN9101 injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Patients will receive a single intravenous infusion of RN9101 injection",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Lei Fan","CONTACT","086+025-68306124","fanlei@jsph.org.cn",[27],{"facility":5,"status":19,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Nanjing","Jiangsu","210029","China","CN",{"type":34,"coordinates":35},"Point",[36,37],118.77778,32.06167,{"lat":37,"lon":36},[40],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":42,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100643266","early-phase-1-safety-and-efficacy-of-rn9101-in-the-treatment-of-relapsedrefractory-multiple-myeloma-100643266",false,"NCT07628595","Safety and Efficacy of RN9101 in the Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Phase 1 Clinical Study Evaluating the Safety and Efficacy of RN9101 in the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be enrolled in this study:\n\n  1. Age ≥18 years, either sex;\n  2. Diagnosis of multiple myeloma (MM) according to IMWG response criteria, with BCMA target antigen expression on MM cells confirmed by flow cytometry or bone marrow pathology and immunohistochemistry;\n  3. Received at least 2 prior lines of anti-multiple myeloma therapy, with each line containing at least one complete treatment cycle, and documented disease progression during or after the most recent anti-myeloma therapy based on assessment data;\n  4. Measurable disease at screening, defined as meeting at least one of the following criteria:\n\n     1. Serum M-protein ≥ 0.5 g\u002FdL;\n     2. Urine M-protein level ≥ 200 mg\u002F24 h;\n     3. Involved serum free light chain ≥ 10 mg\u002FdL with abnormal serum free light chain κ\u002Fλ ratio;\n     4. Clinical relapse: a. New bone lesions or soft tissue plasmacytomas (excluding osteoporotic fractures); b. Definite increase in existing plasmacytomas or bone lesions (sum of the products of perpendicular diameters \\[SPD\\] of measurable lesions increased by ≥50% with an absolute increase of ≥1 cm);\n  5. ECOG performance status of 0-2, with an estimated life expectancy of ≥3 months;\n  6. Bone marrow function test results (at screening or within 2 months prior to screening) meeting the following conditions:\n\n     1. Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week prior to screening), with recombinant human erythropoietin permitted; for patients meeting the hemoglobin ≥ 6 g\u002FdL enrollment criterion, red blood cell transfusions may be allowed to maintain hemoglobin ≥ 6 g\u002FdL;\n     2. Absolute neutrophil count (ANC) ≥ 600\u002FμL (no granulocyte colony-stimulating factor \\[G-CSF\\] used within 1 week prior to screening, or no pegylated G-CSF used within 2 weeks prior to screening);\n     3. Platelet count ≥ 50,000\u002FμL;\n     4. Lymphocyte count ≥ 500\u002FμL;\n     5. Absolute CD3-positive T-cell count ≥ 150\u002FμL;\n  7. Normal renal function during screening or within 2 months prior to screening: creatinine clearance (CrCl) (calculated by the Cockcroft-Gault formula) ≥ 45 mL\u002Fmin;\n  8. Hepatic function during screening or within 2 months prior to screening meeting the following conditions:\n\n     1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN);\n     2. Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert's syndrome, where direct bilirubin may be ≤ 1.5 × ULN);\n     3. Albumin ≥ 3 g\u002FdL;\n  9. Cardiac function during screening or within 2 months prior to screening meeting the following conditions:\n\n     1. Left ventricular ejection fraction (LVEF) ≥ 40% (assessed by echocardiography or MUGA scan);\n     2. No clinically significant pericardial effusion;\n     3. No clinically significant electrocardiogram abnormalities;\n  10. Pulmonary function during screening or within 2 months prior to screening meeting the following conditions:\n\n      1. Oxygen saturation ≥ 90%;\n      2. No clinically significant pleural effusion;\n  11. For females of childbearing potential, a negative pregnancy test at screening and prior to dosing, and not currently breastfeeding;\n  12. Males and females of childbearing potential must agree to use effective contraception from the date of informed consent signing until 1 year after the end of study treatment;\n  13. Males and females of childbearing potential must agree not to donate gametes (including sperm or ova) from the date of informed consent signing until 1 year after the end of study treatment;\n  14. The subject or their legally authorized representative has signed the Informed Consent Form (ICF), indicating understanding of the study objectives and procedures, and voluntary participation in this study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from the study:\n\n  1. Received other anti-tumor therapy during the screening period (as determined primarily by the investigator):\n\n     1. Received targeted therapy, epigenetic therapy, other investigational drug therapy, or treatment involving invasive investigational medical devices within 5 half-lives;\n     2. Received systemic immunologic or non-immunologic therapy within 1 week;\n     3. Received cytotoxic therapy within 1 week;\n     4. Received proteasome inhibitor and immunomodulatory therapy within 2 weeks;\n     5. Received radiotherapy within 4 weeks (except if the radiation field involves ≤5% of bone marrow reserve, in which case there is no restriction on the time since completion of radiotherapy, and the subject may still be enrolled);\n  2. Received allogeneic hematopoietic stem cell transplantation within 6 months prior to dosing, or autologous hematopoietic stem cell transplantation within 3 months prior to dosing;\n  3. History of malignancy other than multiple myeloma prior to screening, except for the following: malignancies treated with curative intent and with no known active disease for ≥2 years prior to enrollment; adequately treated non-melanoma skin cancer with no current evidence of disease;\n  4. Previously received any therapy utilizing vesicular stomatitis virus glycoprotein (VSV-G) pseudotyped virus;\n  5. Presence of severe and uncontrolled infection during screening (including bacterial, viral, fungal, etc.);\n  6. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range detected within 6 months prior to infusion; positive hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal range; positive human immunodeficiency virus (HIV) antibody; positive syphilis test;\n  7. Symptomatic heart failure or other cardiac diseases, such as severe arrhythmias:\n\n     1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n     2. Myocardial infarction within 6 months prior to informed consent signing, or prior coronary artery bypass grafting (CABG) or coronary artery stent implantation;\n     3. Clinically significant ventricular arrhythmias or history of unexplained syncope (excluding vasovagal or dehydration-induced syncope);\n     4. History of severe non-ischemic cardiomyopathy;\n  8. Other clinically significant diseases, including:\n\n     1. Primary immunodeficiency;\n     2. Stroke or seizure within 6 months prior to screening;\n     3. Definite clinical evidence of dementia or altered mental status;\n     4. Parkinson's disease, parkinsonian movement disorders, or relevant history;\n  9. Received surgery within 2 weeks prior to dosing, or planned surgery within 2 weeks after dosing (except for local anesthesia procedures);\n  10. Received live attenuated vaccines within 1 month prior to dosing;\n  11. Known severe allergic reaction to RN9101 or any of its formulation components;\n  12. Known severe allergic reaction to tocilizumab;\n  13. Patients unsuitable for intravenous infusion;\n  14. Other conditions deemed by the investigator as rendering the subject unsuitable for participation in this study.","ALL","18 Years",{"count":53,"type":54},19,"ESTIMATED","INTERVENTIONAL",[57],"EARLY_PHASE1","This is a single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of RN9101 injection for patients with relapsed\u002Frefractory multiple myeloma.",[60],"Multiple Myeloma (MM)","NOT_YET_RECRUITING","2026-06-07",{"date":64,"type":65},"2026-06-10","ACTUAL",{"date":67,"type":54},"2026-07-01",{"date":69,"type":54},"2028-11-01",{"name":5,"class":6},1]