[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chunrui Li\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100456141","phase-1-a-study-of-car-gprc5d-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100456141",false,"NCT05219721","A Study of CAR-GPRC5D in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:\n\n* Subjects must satisfy all the following criteria to be enrolled in the study:\n\n  1. age 18 to 75 years old, male or female.\n  2. Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).\n\n     According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;\n  3. Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).\n  4. The subjects should have measurable disease based on at least one of the following parameters:\n\n     The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.\n\n     Serum M-protein ≥ 0.5 g\u002FdL. Urine M-protein ≥ 200 mg\u002F24 hrs. For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg\u002FdL (100 mg\u002FL) provided serum FLC ratio is abnormal.\n\n     In subjects with extramedullary myeloma, if there are no other evaluable lesions, require extramedullary lesions with a maximum diameter of ≥2cm\n  5. ECOG performance score 0-2.\n  6. Estimated life expectancy ≥ 12 weeks.\n  7. Subjects should have adequate organ function:\n\n     * Hematology: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL; platelets ≥40×10\\^9 \u002FL (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g\u002FL (subjects must not have received transfusion of red blood cells \\[RBC\\] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).\n     * Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n     * Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml\u002Fmin.\n     * Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.\n     * SpO2 \\> 91%.\n     * Left ventricular ejection fraction (LVEF) ≥ 50%.\n  8. The subject and his\u002Fher spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.\n  9. Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.\n\n     Exclusion Criteria:\n* The presence of any of the following will exclude a subject from enrollment:\n\n  1. Subjects who are known to have GVHD or need long-term immunosuppressive therapy.\n  2. Subjects have received any anti-cancer treatment as follows:\n\n     monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.\n  3. Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \\> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.\n  4. Subjects with hypertension that cannot be controlled by medication.\n  5. Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.\n  6. Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.\n  7. Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.\n  8. Subjects with a history of organ transplantation.\n  9. Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).\n  10. Subjects participated in another interventional clinical study 1 months before signing the informed consent (ICF);\n  11. Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).\n  12. Positive for any of the following tests:\n\n      * Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood\n      * Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood\n      * Human immunodeficiency virus (HIV) antibody\n      * Cytomegalovirus (CMV) DNA\n      * Treponema Pallidum antibody\n  13. Pregnant or lactating women.\n  14. Subjects with mental illness or consciousness disorder or disease of the central nervous system\n  15. Other conditions that researchers consider inappropriate for inclusion.","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R\u002FR MM or plasma cell leukemia.",[27,28],"Relapsed\u002FRefractory Multiple Myeloma","Plasma Cell Leukemia",[30,31],"CAR-T","GPRC5D","RECRUITING","2025-06-06",{"date":35,"type":36},"2025-06-11","ACTUAL",{"date":38,"type":36},"2022-03-17",{"date":40,"type":21},"2025-10-01",{"name":42,"class":43},"Chunrui Li","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100576929","early-phase-1-a-study-of-eso-t01-in-treating-relapsed-refractory-multiple-myeloma-100576929","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.",{"count":53,"type":21},24,[55],"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.",[58],"Relapsed\u002F Refractory Multiple Myeloma",[60,61,62],"ESO-T01","Multiple Myeloma","in vivo","2025-02-07",{"date":65,"type":36},"2025-02-11",{"date":67,"type":36},"2025-01-27",{"date":69,"type":21},"2027-11-30",{"name":42,"class":43},""]