[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576929":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":46,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":22,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":22,"enrollmentInfo":62,"targetDuration":22,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ESO-T01 treatment group","EXPERIMENTAL","the third-generation self-inactivating lentiviral vector",[13],"Drug: ESO-T01",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ESO-T01","ESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR.",[9],[21],"BCMA CAR-T",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Chunrui Li","CONTACT","86-13647233185","cunrui5650@126.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Tongji Hospital, Tongji Medical College","RECRUITING","Wuhan","Hubei","430000","China","CN",{"type":39,"coordinates":40},"Point",[41,42],114.26667,30.58333,{"lat":42,"lon":41},[45],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"type":47,"investigatorFullName":25,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Professor",[50],{"name":51,"class":52},"Shenzhen Pregene Biopharma Co., Ltd.","INDUSTRY","100576929","early-phase-1-a-study-of-eso-t01-in-treating-relapsed-refractory-multiple-myeloma-100576929",false,"NCT06791681","A Study of ESO-T01 in Treating Relapsed\u002F Refractory Multiple Myeloma","Clinical Study for Evaluating ESO-T01 Injection's Safety and Efficacy in Treating Relapsed\u002Frefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years；\n2. Diagnosis of multiple myeloma (MM) confirmed according to the IMWG diagnostic criteria, with BCMA expression on MM cells determined by flow cytometry or immunohistochemistry;\n3. Previously treated with at least 2 lines of anti-MM therapy, with at least 1 complete treatment cycle for each line, and disease progression within 12 months after the most recent anti-myeloma treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, along with disease progression within 2 months after the most recent anti-myeloma treatment (according to the IMWG diagnostic criteria);\n4. Disease must be measurable at screening, meeting at least one of the following criteria:Serum M-protein level ≥ 0.5 g\u002FdL; Urinary M-protein level ≥ 200 mg\u002F24h; Serum involved free light chain ≥ 10 mg\u002FdL and an abnormal serum free light chain κ\u002Fλ ratio;\n5. ECOG score 0-2, with an expected survival time ≥ 3 months;\n6. Bone marrow function at screening (or within 2 months prior to screening) meets the following criteria: a.Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin is allowed; for patients who meet the ≥6 g\u002FdL criterion at screening, red blood cell transfusion is allowed to maintain hemoglobin ≥ 6 g\u002FdL; b.Absolute neutrophil count (ANC) ≥ 600\u002FμL (no use of granulocyte colony-stimulating factor (G-CSF) within 1 week or pegylated G-CSF within 2 weeks prior to screening); c. Platelet count ≥ 50,000\u002FμL; d. Lymphocyte count ≥ 500\u002FμL; e. Absolute CD3-positive T cell count ≥ 150\u002FμL;\n7. Renal function at screening (or within 2 months prior to screening) should be normal, with a creatinine clearance ≥ 45 mL\u002Fmin;\n8. Liver function at screening (or within 2 months prior to screening) must meet the following criteria: a. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × the upper limit of normal (ULN); b. Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert's syndrome, where direct bilirubin can be ≤ 1.5 × ULN); c. Albumin ≥ 3 g\u002FdL;\n9. Cardiac function at screening (or within 2 months prior to screening) must meet the following criteria: a. Left ventricular ejection fraction ≥ 40% (measured by echocardiogram or MUGA scan); b. No clinically significant pericardial effusion detected; c. No clinically significant ECG abnormalities detected;\n10. Pulmonary function at screening (or within 2 months prior to screening) must meet the following criteria: Oxygen saturation ≥ 90%;No clinically significant pleural effusion detected;\n11. For women of childbearing potential, a negative pregnancy test must be obtained at screening and prior to drug infusion, and they must not be breastfeeding;\n12. Male and female subjects of childbearing potential must agree to use effective contraception from the time of informed consent until 1 year after the study drug administration;\n13. Male and female subjects of childbearing potential must agree not to donate sperm or eggs (oocytes) or other reproductive cells from the time of informed consent until 1 year after the study drug administration;\n14. The participant or their legally authorized representative must provide written informed consent (ICF), indicating their understanding of the purpose and procedures of the study and their willingness to participate.\n\nExclusion Criteria:\n\n1. Previous anticancer treatment (as determined by the investigator): a. Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive investigational medical devices within 5 half-lives; b. Received immune\u002Fnon-immune-directed systemic therapy within 1 week; Received cytotoxic therapy within 1 week; c. Received proteasome inhibitors or immunomodulatory agent therapy within 2 weeks; d. Received radiotherapy within 4 weeks (if the radiation field covered ≤5% of bone marrow reserve, the subject is eligible regardless of the date of radiotherapy completion);\n2. Received allogeneic HSCT within 6 months prior to infusion, or autologous HSCT within 3 months prior to infusion;\n3. Other malignancies prior to screening (except the following): Malignancies treated with curative intent and no evidence of active disease ≥2 years before enrollment; Adequately treated non-melanoma skin cancer with no evidence of disease;\n4. Previously treated with any viral therapy using VSVG pseudotype virus;\n5. Serious uncontrolled infections during screening: Bacterial, viral, fungal, etc. infections;\n6. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with elevated peripheral blood HBV DNA levels within 6 months prior to infusion; Positive for hepatitis C antibody (HCV Ab) with elevated peripheral blood HCV RNA levels; Positive for HIV antibody; Positive for syphilis;\n7. Symptomatic heart failure or significant arrhythmias: NYHA Class III or IV congestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months prior to signing ICF; Clinically significant ventricular arrhythmias or unexplained syncope (except when caused by vasovagal or dehydration); Significant non-ischemic cardiomyopathy history;\n8. Other significant diseases: Primary immunodeficiency; Stroke or seizure within 6 months prior to screening; Obvious clinical evidence of dementia or altered mental status; History of Parkinson's disease or Parkinsonism;\n9. Surgery within 2 weeks prior to treatment or planned surgery within 2 weeks post-treatment, except for local anesthesia procedures;\n10. Use of live-attenuated vaccines within 1 month before treatment;\n11. Known severe allergic reaction to ESO-T01 or its formulation components;\n12. Known severe allergic reaction to Tocilizumab;\n13. Inability to establish venous access;\n14. Any other condition deemed by the investigator as unsuitable for participation in the study.","ALL","18 Years",{"count":63,"type":64},24,"ESTIMATED","INTERVENTIONAL",[67],"EARLY_PHASE1","This is a single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed\u002Frefractory multiple myeloma.",[70],"Relapsed\u002F Refractory Multiple Myeloma",[17,72,73],"Multiple Myeloma","in vivo","2025-02-07",{"date":76,"type":77},"2025-02-11","ACTUAL",{"date":79,"type":77},"2025-01-27",{"date":81,"type":64},"2027-11-30",{"name":25,"class":6},1]