[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,65,93],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100639831","phase-1-iaso206-in-patients-with-relapsedrefractory-autoimmune-hemolytic-anemia-100639831",false,"NCT07585071","IASO206 in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Phase I Clinical Study on the Safety and Tolerability of IASO206 Injection in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Age 18 to 75 years, gender unrestricted.\n* Diagnosis of AIHA (including warm antibody type, warm-cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with Chinese Expert Consensus on Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), 2019 International Consensus for Diagnosis and Management of Autoimmune Hemolytic Anemia (Blood Rev, 2020), or Chinese Expert Consensus on Diagnosis and Treatment of Evans Syndrome (2024 Edition).\n* Patients with relapsed\u002Frefractory disease after multiple lines of therapy must meet all of the following criteria: hemoglobin \\\u003C 10 g\u002FdL with clinical manifestations of hemolytic anemia; prior treatment with at least 2 immunosuppressive drugs (must include CD20 monoclonal antibody); glucocorticoid therapy for at least 3 months (excluded are patients with contraindications to glucocorticoids, severe infection, severe osteoporosis, previous fracture, or inability to tolerate glucocorticoids); cumulative dose of CD20 monoclonal antibody at least 375 mg\u002Fm² × 4, or total dose 2.0 g, or at least 6 administrations (at least 1 week apart each time).\n* ECOG score ≤ 2.\n* Expected survival time ≥ 12 weeks.\n* Adequate organ function confirmed by laboratory tests: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); minimum pulmonary reserve defined as grade ≤ 1 dyspnea and oxygen saturation ≥ 93% without oxygen supplementation; creatinine clearance (estimated by Cockcroft-Gault) ≥ 45 mL\u002Fmin; cardiac ejection fraction ≥ 50%, no pericardial effusion on echocardiogram (ECHO), and no clinically significant abnormal electrocardiogram (ECG).\n* Subjects and their partners agree to use effective barrier or medical contraceptive measures (excluding rhythm method) from signing informed consent until 1 year after administration.\n* Subjects must provide written informed consent approved by the Ethics Committee prior to initiation of screening procedures\n\nExclusion Criteria:\n\n* Subject with confirmed lymphoproliferative neoplasms.\n* Subject with secondary AIHA induced by drugs or infection.\n* Subject with congenital immunodeficiency diseases, other hereditary or acquired hemolytic diseases.\n* Subject with a history of organ or stem cell transplantation.\n* Subject with a history of organ infarction within the past 6 months.\n* Subject who have received prior BCMA-targeted therapy.\n* Subject who received plasma cell-targeted cell therapy within 3 months before screening, or in whom prior cell therapy products are still detectable in peripheral blood.\n* Subject who received any of the following treatments within the specified periods prior to study enrollment:\n\n  1. Anti-CD20 monoclonal antibody \\\u003C 12 weeks;\n  2. Sutimlimab or other marketed biological products \\\u003C 5 half-lives;\n  3. Plasma exchange \\\u003C 4 weeks;\n  4. Splenectomy \\\u003C 12 weeks.\n* Subject with any of the following cardiovascular diseases:\n\n  1. Left ventricular ejection fraction (LVEF) ≤ 45%;\n  2. Active heart disease or congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV);\n  3. Severe arrhythmia requiring treatment (excluding atrial fibrillation, paroxysmal supraventricular tachycardia);\n  4. QTcB interval ≥ 450 ms for males, ≥ 470 ms for females;\n  5. Myocardial infarction, bypass surgery, or stent implantation within 6 months before study;\n  6. Other cardiac diseases judged by the investigator to be unsuitable for enrollment.\n* Unstable systemic diseases judged by the investigator, including but not limited to severe hepatic or renal diseases requiring medical treatment.\n* Subject with a history of other primary malignancies within 5 years before screening, except:\n\n  1. Resected and cured non-melanoma skin cancer (e.g., basal cell carcinoma);\n  2. Cured carcinoma in situ (e.g., cervical, bladder, or breast cancer);\n  3. Other primary cancers with no evidence of recurrence for more than 5 years after treatment.\n* Subject who underwent major surgery within 4 weeks before screening and are judged unsuitable for enrollment by the investigator.\n* Subject with uncontrolled active fungal, viral, bacterial, mycobacterial, or other infections (persistent infection-related signs\u002Fsymptoms without improvement after appropriate anti-infective therapy) or infections requiring intravenous anti-infective therapy.\n* Positive hepatitis B surface antigen (HBs-Ag) or hepatitis B e antigen (HBe-Ag); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab) with HBV-DNA copy number above the lower limit of quantification; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; active syphilis infection (excluding those with only positive syphilis-specific antibody).\n* Subject who received live viral vaccines within 4 weeks before enrollment.\n* Subject who are participating in other interventional clinical studies during IASO206 Injection treatment with a drug half-life \\\u003C 5; subject receiving active investigational drugs during the entire study period, or who intend to participate in another clinical trial, or receive treatments outside the protocol.\n* Pregnant or lactating females.\n* Subject with psychiatric disorders, disturbance of consciousness, or central nervous system diseases, including but not limited to epilepsy and Parkinson's disease.\n* Subject with hypersensitivity to components of IASO206 Injection or supportive medications required for the management of CAR-T therapy-related toxicities (e.g., tocilizumab).\n* Other conditions judged by the investigator to be unsuitable for enrollment.10. Other Information","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection (In Vivo CAR-T) in Patients with Relapsed\u002FRefractory Autoimmune Hemolytic Anemia",[27,28],"Autoimmune Hemolytic Anemia","Relapsed\u002FRefractory","NOT_YET_RECRUITING","2026-05-06",{"date":32,"type":33},"2026-05-13","ACTUAL",{"date":35,"type":21},"2026-06-15",{"date":37,"type":21},"2028-12-31",{"name":39,"class":40},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100538161","phase-1-phase-ibii-study-assessing-the-clinical-activity-and-safety-of-brexucabtagene-autoleucel-as-a-consolidation-in-patients-with-relapsedrefractory-rr-and-newly-diagnosed-b-cell-acute-lymphocytic-leukemia-all-post-cytoreduction-with-mini-hcvd-inotuzumab-blinatumomabhcvad-inotuzumab-blinatumomab-100538161","NCT06287229","Phase Ib\u002FII Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed\u002FRefractory (R\u002FR) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab\u002FHCVAD-inotuzumab-blinatumomab","Inclusion Criteria:\n\n* Participants of age ≥18 years with documented relapsed or refractory B-cell ALL\n* In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as:\n\n  1. KMT2A rearranged ALL\n  2. Complex cytogenetics as per NCCN 2022\n  3. Low-hypodiploidy\u002Ftetraploidy\n  4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)\n* Performance status of 0, 1, or 2\n* Adequate organ function with creatinine less than or equal to 1.6 mg\u002Fdl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal\n* Participants should be CD19 expression positive (\\>50%) before enrollment\n* Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I\u002FII will be eligible if they are on therapy and infections are under control.\n\nExclusion Criteria\n\n* Philadelphia positive B-cell ALL\n* Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization\n* Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy\n* Active and uncontrolled disease\u002Finfection as judged by the treating physician\n* Unable or unwilling to sign the consent form\n* No other investigational therapy within the past 14 days",{"count":48,"type":21},40,[24,50],"PHASE2","To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed\u002Frefractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed\u002Frefractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.",[28,53],"B-cell Acute Lymphocytic Leukemia","RECRUITING","2026-04-21",{"date":57,"type":33},"2026-04-24",{"date":59,"type":33},"2024-07-11",{"date":61,"type":21},"2030-12-31",{"name":63,"class":40},"M.D. Anderson Cancer Center",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":64},"100592868","early-phase-1-a-study-to-evaluate-cg-105-12-in-patients-with-relapsedrefractory-multiple-myeloma-100592868","NCT06999031","A Study to Evaluate CG-105-12 in Patients With Relapsed\u002FRefractory Multiple Myeloma","An Exploratory Clinical Study on the Safety and Efficacy of Autologous T Cell Injection Targeting BCMA Chimeric Antigen Receptor (CG-105-12) in the Treatment of Patients With Relapsed \u002F Refractory Multiple Myeloma","Inclusion Criteria:\n\n* 1.Aged 18-75 years (inclusive of 18 and 75 years old), gender not limited;\n* 2.Subject has received at least 3 lines of therapy, including at least proteasome inhibitors (PIs) and immunomodulatory therapy (IMiD); disease relapse, progression, or refractory according to the International Myeloma Working Group (IMWG) Consensus (2016) criteria for multiple myeloma;\n* 3.Subjects whose tumor specimens were positive for BCMA expression on the membrane surface of plasma cells by immunohistochemistry (IHC) or flow cytometry and had not received prior BCMA CAR-T therapy;\n* 4.One of the following is met (all data below are compared to the obtained minimum values):\n* \\- a. Serum M-protein increased by more than 25% (absolute increase greater than 5 g\u002FL) or M-protein increased by more than 10 g\u002FL (if baseline serum M-protein is greater than 50 g\u002FL);\n* \\- b. Uroprotein increased by more than 25% (absolute increase greater than 200 mg\u002F24h);\n* \\- c. The difference between affected and unaffected serum FLC increased by more than 25% and the absolute value increased by more than 100 mg\u002FL;\n* \\- d.The proportion of bone marrow plasma cells increased by more than 25% and the absolute value increased by more than 10%;\n* \\- e. The sum of the original maximum vertical diameter products of more than one measurable lesion increased by at least 50% from the lowest point; or the long axis of the original lesion of at least 1 cm increased by at least 50%;\n* \\- f. An increase in circulating plasma cells of at least 50% (used when only circulating plasma cells are measurable lesions, with an absolute value of at least 200 cells per microlitre);\n* 5.ECOG performance status score of 0-2；\n* 6.Expected survival ≥12 weeks；\n* 7.Subjects must have adequate organ function and meet all of the following laboratory test results prior to enrollment:\n* \\- a.Complete blood count: Neutrophil count (ANC) 1E9\u002FL; Lymphocyte count (ALC) 0.5E9\u002FL; Platelet count \\>50E9\u002FL; Haemoglobin \\>60g\u002FL or Haematocrit \\>0.24；\n* \\- b.Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5 times the upper limit of normal (ULN); serum total bilirubin less than 1.5 times the ULN;\n* \\- c.Renal function: The creatinine clearance rate calculated according to the Cockcroft-Gault formula is GFR 40ml\u002Fmin (except for those whose renal function is abnormal due to progression of the primary disease as judged by the investigator);\n* \\- d.Coagulation function: fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time ≤1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN;\n* \\- e.Blood oxygen saturation \\> 91%;\n* \\- f.Left ventricular ejection fraction (LVEF) ≥ 50%;\n* 8.Subjects and their spouses agreed to use effective instrumental or medical contraception (except for safe contraception) from the time of signing the informed consent form until one year after CAR-T cell reinfusion;\n* 9.Participants must personally sign a written informed consent form approved by the Ethics Committee prior to the start of any screening procedure.\n\nExclusion Criteria:\n\n* 1.Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive with detectable Hepatitis B Virus (HBV) DNA in peripheral blood; Hepatitis C Virus (HCV) antibody positive with peripheral blood positive for Hepatitis C Virus (HCV) RNA; Human Immunodeficiency Virus (HIV) antibody positive; and Syphilis test positive.\n* 2.Prior antitumor therapy as follows:\n* \\- a.Treatment of multiple myeloma with monoclonal antibodies, CNS radiotherapy within 8 weeks prior to single nucleated cell collection;\n* \\- b.or cytotoxic chemotherapy, immunomodulator therapy, or proteasome inhibitor therapy within 14 days prior to single nucleated cell collection;\n* \\- c.or have received granulocyte-macrophage colony-stimulating factor (GM-CSF), long-acting granulocyte colony-stimulating factor (G-CSF) within 14 days prior to the single nucleated cell collection;\n* 3.Has used therapeutic doses of corticosteroids (defined as prednisone or equivalent \\>20 mg\u002Fday) within 7 days prior to screening, but physiologic replacement, topical and inhaled steroids are permitted;\n* 4.have received treatment containing bendamustine or fludarabine within 12 weeks prior to screening;\n* 5.Plasma cell leukemia, patients suspected or suspected of having plasma cell tumor central nervous system invasion during screening;\n* 6.patients with previous allogeneic hematopoietic stem cell transplantation;\n* 7.malignancies other than multiple myeloma within 5 years prior to screening, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancers, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery;\n* 8.subjects with a history of solid organ transplantation;\n* 9.Subjects who have undergone major surgery ( 3 level) within 2 weeks prior to the collection of individual nuclear cells, or who plan to have surgery within 2 weeks after the study treatment (subjects who plan to have local anesthesia surgery can participate in this study);\n* 10.have received a live attenuated vaccine within ≤ 4 weeks prior to administration of the pretreatment regimen;\n* 11.Presence of severe underlying diseases, such as:\n* \\- a.Patients with autoimmune diseases (systemic lupus erythem- atosus, multiple sclerosis, rheumatoid arthritis, etc.) who need long-term use of immunosuppressants (methotrexate, cycl - ophosphamide, etc.), biological agents (infliximab, tozumab, etc.), glucocorticoids (prednisone, dexamethasone, etc.);\n* \\- b.Uncontrolled active infection within 7 days prior to collection of a single nuclear cell, and evidence of severe active viral, bacterial infection or uncontrolled systemic fungal infection;\n* \\- c.Diabetes that cannot be controlled by combination therapy;\n* \\- d.Severe cardiac disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA \\[NYHA\\] class III or higher), and severe arrhythmia;\n* \\- e.Patients with hypertension that cannot be controlled by drug therapy, that is, those with hypertension who cannot be reduced to the following range after combined treatment with 2 drugs (systolic blood pressure \\\u003C160 mmHg, diastolic blood pressure \\\u003C100 mmHg);\n* \\- f.Comorbid psychiatric or psychotic disorders or central nervous system disorders;\n* 12.receiving other interventional clinical trial medications within 1 month prior to signing the Informed Consent Form (ICF);\n* 13.Pregnant or breastfeeding women, women\u002Fmen of chil - dbearing age who have a plan to become pregnant during the trial period and within 6 months after the end of the trial;\n* 14.Patients with a history of severe allergic reaction, or allergic reaction to any drug and related excipient specified in the protocol and judged by the investigator not suitable for enrollment;\n* 15.Other conditions that the investigator considers unsuitable for enrollment.",{"count":73,"type":21},12,[75],"EARLY_PHASE1","This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-105-12 in the participants with BCMA-positive relapsed\u002Frefractory multiple myeloma who previously received adequate but uneffective standard treatments.",[28,78],"Multiple Myeloma",[80,81,82,83],"multiple myeloma","relapsed\u002Frefractory","chimeric antigen receptor T Cell","BCMA","2025-05-22",{"date":86,"type":33},"2025-05-31",{"date":88,"type":33},"2024-09-05",{"date":90,"type":21},"2027-09-30",{"name":92,"class":40},"The First Affiliated Hospital of Nanchang University",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":112,"locationsCount":64},"100560783","phase-2-chimeric-antigen-receptor-modified-t-cells-targeting-bcma-for-the-treatment-of-relapsedrefractory-multiple-myeloma-100560783","NCT06581640","Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age 18-80 years, no gender restrictions;\n2. Diagnosed with refractory\u002Frelapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;\n3. Flow cytometry or histology confirms positive BCMA expression in myeloma cells;\n4. As judged by the investigator, the expected survival time is \\>3 months;\n5. ECOG performance status score ≤2, KPS \\>60%;\n6. The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin \\\u003C34 μmol\u002FL; creatinine clearance rate \\>30 mL\u002Fmin; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;\n7. Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10\\^9\u002FL, PLT \\>30×10\\^9\u002FL, Hb \\>80 g\u002FL and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;\n8. Those with fertility must agree to use highly effective contraceptive methods;\n9. The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.\n\nExclusion Criteria:\n\n1. Pregnant or nursing women, as well as women planning to become pregnant within the next six months;\n2. Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;\n3. History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);\n4. Previously received treatment targeting BCMA;\n5. Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;\n6. Presence of uncontrolled active bacterial or fungal infection;\n7. Allergic to research-related drugs or cell components;\n8. Presence of active autoimmune diseases;\n9. Currently have unstable or active ulcers or gastrointestinal bleeding;\n10. Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;\n11. Received other experimental drug treatments within the last 3 months;\n12. The researcher believes that for other reasons, the individual is not suitable for the clinical trial.","80 Years",{"count":102,"type":21},5,[50],"To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed\u002Frefractory multiple myeloma",[78,28],"2024-09-23",{"date":108,"type":33},"2024-09-25",{"date":110,"type":33},"2024-09-24",{"date":37,"type":21},{"name":113,"class":40},"The First Affiliated Hospital of Xiamen University"]