[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"blinatumomab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:blinatumomab":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,64,84,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100614749","phase-1-a-phase-ib-trial-of-subcutaneous-blinatumomab-in-combination-with-revumenib-for-patients-with-kmt2a-rearranged-acute-lymphoblastic-leukemia-100614749",false,"NCT07283640","A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia","Eligibility Criteria\n\n• The following groups of participants will be eligible:\n\n* Participants \\> 18 years of age with relapsed and\u002For refractory (defined as \\>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or\n* Participants \\>18 years of age with persistent measurable residual disease by flow cytometry or next generation sequencing KMT2A-r B-cell ALL or\n* Newly diagnosed participants with KMT2A-r B-cell ALL \\> 60 years old or unfit for intensive chemotherapy\n\nUnfit for intensive chemotherapy defined as:\n\n* ECOG \\>2\n* Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \\\u003C50%, or chronic stable angina)\n* Severe pulmonary disorder (e.g., DLCO \\\u003C65% or FEV1 \\\u003C65%)\n* Creatinine clearance \\\u003C45 ml\u002Fmin\n* Hepatic disorder with total bilirubin 1.5 x upper limit of normal\n* Performance status \\\u003C2 per ECOG scale (for R\u002FR participants)\n* Adequate liver function as defined by the following criteria:\n\n  * Total serum bilirubin \\\u003C1.5 x upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN\n* Adequate pancreatic function as define by serum lipase and amylase \\\u003C 1.5 x ULN\n* For females of childbearing potential, a negative pregnancy test must be documented (negative serum pregnancy test performed at the time of screening and negative serum or urine pregnancy test prior to the first dose of study drug)\n* The effects of blinatumomab and revumenib on the developing human fetus are unknown. For this reason and because menin inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab and revumenib administration. Males must also agree to refrain from sperm donation during this time period.\n* Adequate cardiac function as assessed clinically by history and physical examination with an ejection fraction of \\>50% by echocardiogram or multigated acquisition (MUGA) scan\n* White blood cell (WBC) count below 25,000\u002FuL at the time of enrollment. Participants may receive cytoreduction with dexamethasone and\u002For cyclophosphamide for cytoreduction\n* Estimated glomerular filtration rate (GFR) based on local institutional practice for age appropriate determination by Cockcroft Gault formular for adults, with a GFR\\>60 ml\u002Fmin\u002F1.73m2\n* For participants having previously received stem cell transplant, at least 60 days must have elapsed, and for prior donor lymphocyte infusion, at least 4 weeks must have elapsed\n* For participants having previously received immunotherapy, at least 60 days must have passed\n* Weight of at least 40 kg\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics\n* Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year\n* Participants with psychiatric illness that would limit compliance with study requirements\n* Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)\n* Detectable HIV viral load within the previous 6 months. Participants with a known history of HIV must have viral load testing prior to study enrollment.\n* Any of the following within 6 months prior to study entry: myocardial infarction, congestive heart failure New York Heart Association Classification Class \\> II, life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack\n* QTc using Friderica's correction (QTcF) \\>450 msec\n* Personal of family history of long QT syndrome\n* Cirrhosis with a Child Pugh score of B or C\n* Participants with active hepatitis B (defined as Hepatitis B surface antigen with detectable Hepatitis B virus DNA by PCR) or hepatitis C infection (defined as presence of detectable Hepatitis C virus RNA by PCR)","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed\u002Frefractory Ph-negative ALL with a KMT2A rearrangement.",[25,26,27,28],"Blinatumomab","Revumenib","Lymphoblastic Leukemia","KMT2A-rearranged","NOT_YET_RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":19},"2026-11-18",{"date":37,"type":19},"2031-08-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100607721","phase-2-phase-2-study-to-assess-the-safety-and-efficacy-of-subcutaneous-blinatumomab-in-patients-with-measurable-residual-disease-positive-b-cell-acute-lymphoblastic-leukemia-100607721","NCT07192237","Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria\n\n* Participants of age ≥18 years with documented B-cell ALL with recurrent or persistent MRD (at a sensitivity of 10-6) while in morphological remission (Includes Ph-, Ph+ and Ph-like).\n* ECOG 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\u002Fdl and ALT and\u002For AST less than or equal to 5 times institutional upper limit of normal.\n* The effects of blinatumomab on the developing human fetus are unknown. For this reason and because bispecific T-cell engager agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Pregnant women are excluded from this study because Blinatumomab, a bispecific T-cell engager agent has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with blinatumomb, breastfeeding should be discontinued if the mother is treated with blinatumomab. These potential risks may also apply to other agents used in this study.\n* Women of child-bearing potential (WOCBP) must have negative urine or serum pregnancy test within 1 week of study therapy initiation. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.\n* Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 4 months after the last dose of protocol specified therapy.\n* Symptomatic CNS leukemia\n* History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including ICANS from prior CART or other T cell engager therapies.\n* Isolated extramedullary B-cell ALL\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.\n* Active acute or chronic graft versus host disease post-allogeneic HSCT requiring systemic treatment with immunosuppressive medication.\n* Prior history of therapy with SQ blinatumomab for R\u002FR B-cell as part of a clinical trial (but not prior therapy with IV blinatumomab)\n* Known hypersensitivity to blinatumomab or to any component of the product formulation\n* Uncontrolled HIV, HBV, HCV infections\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\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":49,"type":19},40,[51],"PHASE2","To find out if giving blinatumomab as injections under the skin can help to control MRD and keep the disease from coming back in participants with B-cell ALL.",[54,25,55],"Phase 2 Study","Acute Lymphoblastic Leukemia","2026-04-29",{"date":58,"type":33},"2026-05-05",{"date":60,"type":19},"2026-09-27",{"date":62,"type":19},"2032-10-12",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":20,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":41},"100606696","phase-2-phase-ii-study-of-the-combination-of-subcutaneous-blinatumomab-and-olverembatinib-in-patients-with-philadelphia-chromosome-ph-positive-andor-bcrabl1-positive-acute-lymphoblastic-leukemia-all-100606696","NCT07178912","Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and\u002For BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)","Eligibility Criteria\n\n* Diagnosis of one of the following:\n\n  o Participants ≥18 years of age with newly diagnosed or relapsed\u002Frefractory Ph-positive and\u002For BCR::ABL1-positive ALL (includes Participants initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. Participants with newly diagnosed disease could have received one or two courses of chemotherapy with or without other TKIs and still eligible (Participants with lymphoid accelerated or blast phase CML will be evaluated separately).\n* Performance status ≤2 (ECOG Scale).\n* Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n  * Total serum bilirubin \\\u003C2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN.\n* Adequate pancreatic function as defined by serum lipase and amylase \\\u003C1.5 x ULN.\n* For females of childbearing potential, a negative urine pregnancy test must be documented.\n* Female Participants who:\n\n  * Are postmenopausal for at least 1 year before the screening visit, OR\n  * Are surgically sterile, OR\n  * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n* Male Participants, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n  * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n  * Agree to completely abstain from heterosexual intercourse.\n* Adequate cardiac function as assessed clinically by history and physical examination.\n* Signed informed consent.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics.\n* Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nActive grade III-V cardiac failure as defined by the New York Heart Association criteria.\n\n* Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  * Myocardial infarction, stroke, or revascularization within 3 months\n  * Unstable angina or transient ischemic attack\n  * Congestive heart failure prior to enrollment, or left ventricular ejection fraction less than lower limit of normal per local institutional standards prior to enrollment\n  * Diagnosed or suspected congenital long QT syndrome\n  * Clinically significant atrial or ventricular arrhythmias (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician\n  * Prolonged QTc interval on pre-entry electrocardiogram (\\>470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n  * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated thrombosis will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility\n  * Uncontrolled hypertension (diastolic blood pressure \\>90 mmHg, systolic \\>140 mmHg). Participants with hypertension should be under treatment on study entry for blood pressure control.\n* History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Participants with active CNS leukemia will not be excluded.\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.\n* Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days before study entry, unless full recovery from side effects has occurred or Participant has rapidly progressive disease judged to be life-threatening by the investigator.\n* Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n* History of significant bleeding disorder unrelated to cancer, including:\n\n  * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n  * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).\n* Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.",{"count":71,"type":19},60,[51],"To find out if giving blinatumomab as injections under the skin and olverembatinib can help to control the disease in patients with Ph-positive ALL.",[75,25,76,27,77],"Phase II Clinical Trial","Olverembatinib","Philadelphia Chromosome Positive",{"date":58,"type":33},{"date":80,"type":19},"2026-08-27",{"date":82,"type":19},"2033-09-30",{"name":39,"class":40},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":15,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":20,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"100591827","phase-2-full-course-immunotherapy-consolidation-for-unfit-or-fit-b-all-who-decline-chemotherapy-100591827","NCT06985485","Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy","A Phase II Trial of Sequential Blinatumomab and Inotuzumab Ozogamicin in Newly Diagnosed (Unfit\u002FFit-Declined), Relapsed\u002FRefractory, and MRD-Positive B-ALL","Inclusion Criteria:\n\n1. Newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) patients aged ≥60 years, as per NCCN guidelines.\n2. Newly diagnosed B-ALL patients aged ≥15 to \\\u003C60 years who are unfit for intensive chemotherapy (Unfit), as per NCCN guidelines, meeting at least one of the following criteria:\n\n1、ECOG score ≥2 2、Severe cardiac comorbidities (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction ≤50%, unstable angina) 3、Severe pulmonary comorbidities (e.g., DLCO ≤65%, FEV1 ≤65%) 4、Severe renal comorbidities (e.g., serum creatinine \\>2×upper limit of normal (ULN), creatinine clearance \\\u003C45 mL\u002Fmin by any formula) 5、Severe hepatic comorbidities (e.g., total bilirubin \\>1.5×ULN, AST\u002FALT\u002FALP \\>3×ULN) 6、Active infection refractory to antimicrobial therapy 7、Documented cognitive impairment 8、Other comorbidities contraindicating intensive chemotherapy (3) Newly diagnosed B-ALL patients aged ≥15 to \\\u003C60 years with good performance status and adequate organ function who decline intensive chemotherapy for subjective reasons (Fit-Declined), as per NCCN guidelines (e.g., fear of toxicity, financial\u002Fsocial\u002Fpsychological factors, preference for quality of life).\n\n(4) Patients aged ≥15 years with relapsed\u002Frefractory B-ALL or MRD positivity after prior chemotherapy (5) All patients must meet the following organ function requirements:\n\n1. Left ventricular ejection fraction (LVEF) ≥40% by echocardiogram\n2. Creatinine clearance ≥30 mL\u002Fmin (by any formula)\n3. ALT and AST ≤3×ULN, total bilirubin ≤2×ULN (unless attributed to leukemia)\n4. ≤Grade 1 dyspnea and oxygen saturation \\>91% without supplemental oxygen (6) Ability to understand and voluntarily sign the informed consent form. (7) Life expectancy ≥3 months.\n\nExclusion Criteria:\n\n1. Presence of central nervous system (CNS) or other extramedullary disease.\n2. Concurrent other active malignancies or malignancies requiring treatment.\n3. Prior exposure to CD19- or CD22-targeted therapies (including but not limited to CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or\u002Fand CD22 CAR-T).\n4. Use of immunosuppressive agents within 2 weeks prior to signing informed consent, or planned long-term immunosuppressive therapy after enrollment.\n5. Active cardiac disease (NYHA Class ≥3 as assessed by medical history and physical examination).\n6. Severe chronic liver disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis \\[HBsAb-positive, HCVAb-positive\\]).\n\n1、Patients with occult or prior HBV infection (defined as HBcAb-positive, HBsAg-negative) are eligible only if HBV DNA PCR is negative, and require monthly HBV DNA monitoring with prophylactic antiviral therapy.\n\n2、HCV antibody-positive patients are eligible only if HCV RNA PCR is negative. 3、History of confirmed severe or persistent veno-occlusive disease\u002Fsinusoidal obstruction syndrome (VOD\u002FSOS).\n\n(7) Bacterial, fungal, viral, mycoplasma, or other infections that are uncontrolled as judged by the investigator; HIV, syphilis, or SARS-CoV-2 infection.\n\n(8) Past or current CNS disorders, such as seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease.\n\n(9) Primary immunodeficiency or active autoimmune disease. (10) History of severe immediate hypersensitivity to any study drugs. (11) Receipt of live vaccine within 6 weeks prior to screening. (12) Psychiatric disorders or other conditions that may compromise compliance with study requirements, treatment, or monitoring.\n\n(13) Pregnant or breastfeeding women, or fertile patients unwilling to use contraception.\n\n(14) Any other condition deemed unsuitable for study participation by the investigator.","15 Years",{"count":93,"type":19},26,[51],"This trial is a non-blinded, single-center, open-label, single-arm clinical study to evaluate a full-course immunotherapy regimen in patients with B-cell acute lymphoblastic leukemia (B-ALL). The study population includes newly diagnosed patients who are unfit for or decline intensive chemotherapy, as well as patients with relapsed\u002Frefractory disease or with measurable residual disease (MRD) positivity following prior chemotherapy. The trial aims to explore the efficacy and safety of sequential therapy with a CD19-directed CD3 T-cell engager and inotuzumab ozogamicin. The primary endpoint is overall survival (OS), while secondary endpoints include complete remission rate (CRR)、Objective Response Rate (ORR)、Event-free survival (EFS)、Relapse-free survival (RFS)、Cumulative incidence of relapse (CIR)、Non-relapse mortality (NRM) and safety.",[55,97,25,98],"Immunotherapy","Inotuzumab Ozogamicin","RECRUITING","2026-03-20",{"date":102,"type":33},"2026-03-24",{"date":104,"type":33},"2025-05-17",{"date":106,"type":19},"2027-12-31",{"name":108,"class":40},"The First Affiliated Hospital of Soochow University",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":20,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100576731","phase-1-blinatumomab-in-refractory-active-childhood-systemic-lupus-erythematosus-100576731","NCT06789107","Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus","Clinical Trial of Blinatumomab in Refractory\u002FActive Systemic Lupus Erythematosus in Children","BRASLE","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible for enrollment:\n\n1. Age: ≥ 5 years old.\n2. Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR\u002FACR classification criteria.\n3. Positive Antibody: At least one of the following antibodies positive within 12 months before screening or during the screening period:\n\n   * Antinuclear antibody (ANA) ≥ 1:80.\n   * Anti-double-stranded DNA (anti-dsDNA) antibody above the upper limit of normal (ULN).\n   * Anti-Smith (Anti-Sm) antibody above the ULN.\n4. Treatment Resistance: Inadequate response to at least three of the following:\n\n   * Oral corticosteroids (OCS),\n   * Antimalarials,\n   * Conventional immunosuppressants (e.g., cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide),\n   * Biologics (e.g., TULIP-2, belimumab, rituximab). At least one treatment must involve immunosuppressants or biologics.\n5. SLEDAI-2000 Score: ≥ 6 based on the SLEDAI-2000 scoring system.\n6. Stable Standard Treatment: Currently receiving one or more of the following treatments at a stable dose:\n\n   * OCS (e.g., prednisone acetate or equivalent) at a stable dose for ≥7 days prior to initiation;\n   * Antimalarials: Dose stable for at least 7 days prior to the first dose.\n   * Conventional immunosuppressants: Stable dose for at least 4 weeks before screening and throughout the study.\n7. Laboratory Parameters:\n\n   * Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹\u002FL.\n   * Peripheral CD19+ B cell count ≥ 25 cells\u002FμL.\n   * Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹\u002FL.\n   * Hemoglobin ≥ 80 g\u002FL.\n   * Platelet count ≥ 75 × 10⁹\u002FL \\*.\n   * Left ventricular ejection fraction (LVEF) ≥ 55% with no significant ECG abnormalities.\n   * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m².\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin ≤ 2 × ULN.\n   * No severe pulmonary lesions, SpO₂ ≥ 92%.\n8. Contraception: Female participants of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the study and for 1 year after infusion.\n9. Informed Consent: The participant and their legal guardian must provide written informed consent, demonstrating understanding of the study objectives and willingness.\n\n   * Note: For SLE patients with thrombocytopenia below the inclusion threshold due to immune-related causes, and without active bleeding, investigators may use clinical discretion to determine eligibility.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Central nervous system disease: active or unstable lupus-related neuropsychiatric disease within 60 days, including epilepsy, confusion, cerebrovascular events, etc.;\n2. Acute severe nephritis: renal replacement therapy within 3 months before the screening period or ongoing, or significant kidney disease that, in the opinion of the investigator, may occur and lead to the need for high-dose glucocorticoid (prednisone dose ≥ 2 mg\u002Fkg\u002Fd or equivalent of other hormones), cyclophosphamide or escalated MMF treatment within the first 3 months of the study;\n3. Severe antiphospholipid syndrome within 12 months before or during screening；\n4. Congenital heart disease or a history of acute myocardial infarction within 6 months before screening, or severe arrhythmia (including polymorphic ventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs, patients who need blood pressure-raising drugs to maintain blood pressure;\n5. Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;\n6. Having active infections or uncontrollable infections that require systemic treatment within one week before screening;\n7. Having received solid organ transplantation or hematopoietic stem cell transplantation within three months before screening; or having grade 2 or higher acute graft-versus-host disease (GVHD) within two weeks before screening;\n8. History of severe recurrent or chronic infections, especially recurrent or chronic infections associated with respiratory problems.\n9. Immunoglobulin G levels below the lower limit (5-8 years: \\\u003C4.5 g\u002FL, 9 years and older: \\\u003C6.0 g\u002FL);\n10. History of hepatitis B virus (HBV) infection or positive serology indicating current or past HBV infection. Human immunodeficiency virus (HIV; positive HIV antibody test) and active hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid \\[RNA\\]). Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection;\n11. A history of tuberculosis or active tuberculosis; or latent tuberculosis treated before the baseline; or subjects with an indeterminate test result who screened positive for PPD or T-spot can be retested, but if the repeat test is also indeterminate, they are excluded;\n12. Had a history of macrophage activation syndrome within 1 month prior to screening;\n13. Had received any anti-CD19 or anti-CD20 therapy, such as rituximab, obinutuzumab, ocrelizumab, or ofatumumab, within 3 months prior to screening or during screening;\n14. Received a JAK inhibitor, Bruton tyrosine kinase (BTK) inhibitor, or tyrosine kinase 2 (TYK2) inhibitor, such as baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or zanubrutinib and Fenebrutinib, during screening;\n15. Treatment with cyclophosphamide or a biologic agent within 4 weeks prior to enrollment, including but not limited to adalimumab, etanercept, golimumab, infliximab, Infliximab), Belimumab, Ustekinumab, Anifrolumab, Secukinumab, or Atacicept;\n16. Intolerance or contraindication to the investigational therapy, including a history of severe allergies or allergic reactions to monoclonal antibodies, or a known hypersensitivity to any of the ingredients in belimumab injection;\n17. Live vaccine within 4 weeks prior to screening;\n18. Positive blood pregnancy test;\n19. Patients with known malignant diseases such as tumors before screening;\n20. Patients who have participated in other clinical trials within 3 months prior to enrollment;\n21. Patients with depression or suicidal tendencies;\n22. Other situations where the investigator believes the patient is not suitable for participation in the study.","5 Years",{"count":119,"type":19},6,[22],"The goal of this clinical trial is to learn if blinatumomab works to treat refractory or active systemic lupus erythematosus (SLE) in children and adults. It will also learn about the safety of blinatumomab. The main questions it aims to answer are:\n\nDoes blinatumomab improve symptoms and disease activity in refractory\u002Factive SLE? What side effects or adverse events do participants experience when taking blinatumomab?\n\nParticipants will:\n\nReceive two courses of blinatumomab injections over five consecutive days each Be monitored for 52 weeks to evaluate the treatment's safety and effectiveness Undergo regular blood tests and assessments of disease activity during follow-up visits Researchers will collect data on changes in serological markers, disease symptoms, and adverse events throughout the study.",[123,124,25],"Systemic Lupus Erythematosus (SLE)","Children","2025-11-22",{"date":127,"type":33},"2025-11-28",{"date":129,"type":33},"2024-12-08",{"date":131,"type":19},"2027-12-07",{"name":133,"class":40},"Mao Jianhua",2]