[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bispecific-antibody\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bispecific-antibody":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,79,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100616737","pragmatic-geriatric-assessment-before-car-t-or-bispecific-antibody-therapy-to-predict-side-effects-and-outcomes-in-older-patients-ga-act-trial-100616737",false,"NCT07309497","Pragmatic Geriatric Assessment Before CAR-T or Bispecific Antibody Therapy to Predict Side Effects and Outcomes in Older Patients (GA-ACT Trial)","Pragmatic Geriatric Assessment (pGA) Before Bispecific Antibody and CAR-T-Cell Therapy (GA-ACT Trial) for the Prediction of Toxicity and Outcomes in Older Patients Scheduled for Chimeric Antigen Receptor T-Cell Therapy (CAR-T-Cell-Therapy) or Bispecific Antibody (bsAB) Treatment","GA-ACT","Inclusion Criteria:\n\n* male or female patients age ≥ 65 years,\n* scheduled for CAR-T-cell or bsAB treatments\n* signed informed consent\n* sufficient knowledge of the German or French language\n\nExclusion Criteria:\n\n* inability to understand or sign informed consent\n* refuse to consent","ALL","65 Years",{"count":20,"type":21},208,"ESTIMATED","OBSERVATIONAL","CAR-T cell or bispecific antibody therapies are a new treatment option for adult patients with aggressive forms of lymphoma or so-called plasma cell diseases ('multiple myeloma', 'plasma cell myeloma') that could not be cured with other, less intensive approaches. However, these are intensive therapies that can be associated with severe and potentially life-threatening side effects. Although there is no age limit for these therapies, we know little about the short- and long-term side effects of these treatments in people of advanced age.\n\nAlthough a small number of patients in the pivotal studies were even over 80 years old, their number was too small to be able to assess the tolerability and success specifically in people over 65. At present, the treating physicians decide whether and, if so, which patients are considered 'fit' enough for this therapy. An objective assessment of the kind we want to investigate in our study does not currently exist on a regular basis. In this study, we therefore want to use simple clinical methods to investigate the effects of these forms of therapy in different areas of everyday function that are important for people in older age (mobility, memory, self-care skills, nutrition). We want to find out whether these investigations help to predict the risk of severe and\u002For long-term side effects. Based on the results, a pragmatic geriatric assessment could be introduced as standard before these therapies. Older patients could thus expect an improvement in their quality of life thanks to more predictable risks and side effects. Standardized screening could lead to lower healthcare costs for treatment and aftercare for both forms of therapy.",[25,26,27,28],"Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","CART Therapy","Bispecific Antibody","Geriatric Hematology",[30,31,32,33,34,35,36,37],"geriatric assessment","lymphoma","multiple myeloma","bispecific antibodies","chimeric antigen receptor","outcome assessment","toxicity","health related quality of life","RECRUITING","2025-12-15",{"date":41,"type":42},"2025-12-30","ACTUAL",{"date":44,"type":42},"2025-12-12",{"date":46,"type":21},"2028-02-01",{"name":48,"class":49},"University of Zurich","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100610720","phase-2-glofitamab-plus-polatuzumab-vedotin-and-zuberitamab-in-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100610720","NCT07231250","Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma","Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma: A Multicenter Phase II Study","Inclusion Criteria:\n\n* The following criteria must be met to be eligible for the study:\n\n  1. Written informed consent.\n  2. Age ≥18 years at the time of signing the Informed Consent Form\n  3. IPI score 2-5.\n  4. ECOG performance status of 0-2.\n  5. Histologically confirmed CD20-positive LBCL, including one of the following diagnoses by 2022 WHO classification of lymphoid neoplasms:\n* DLBCL, not otherwise specified (NOS) including germinal B-cell type, activated B-cell type\n* T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n* Epstein-Barr virus-positive DLBCL, NOS\n* Anaplastic lymphoma kinasepositive large B-cell lymphoma\n* Kaposi's sarcomaassociated herpesvirus\u002Fhuman herpesvirus-8positive DLBCL\n* DLBCL\u002FHGBCL with MYC and BCL2 rearrangements\n* HGBCL, NOS. (6) At least one measurable site of disease (\\>1.5 cm long axis). (7) No previous treatment for lymphoma. (8) Life expectancy ≥6 months. (9) Left ventricular ejection fraction (LVEF) ≥50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) (10) Patient has adequate liver function:\n\n  * Total bilirubin ≤1.5 x ULN (≤3 x ULN in patients with Gilbert's syndrome).\n  * AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤3 x ULN.\n\n    o Patients with documented liver involvement: AST and\u002For ALT ≤5 x ULN. (11) Patient has adequate hematological function, unless due to lymphoma:\n  * Hemoglobin ≥9.0 g\u002FdL within 7 days before the first treatment.\n  * Absolute neutrophil count of ≥1.0 x 109 cells\u002FL (1,000\u002FμL).\n  * Platelet count of ≥75 x 109 cells\u002FL (75,000\u002FμL). Note: Transfusion of RBCs and platelets is allowed to reach the inclusion criteria. In case screening procedures are leading to situations that would exclude the patient from study participation (such as Hb value below entry criteria), the patient may still be enrolled into the trial after consultation with the principal investigator.\n\n    (12) Patient has adequate renal function:\n  * Creatinine ≤ 1.5 x ULN, or Creatinine clearance (CrCl) calculated by Cockcroft-Gault formula of ≥ 30 mL\u002Fmin for patients in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function.\n\nExclusion Criteria:\n\n* Patients who meet at least one of the following criteria are not eligible for trial participation:\n\n  1. History of severe cardiac disease: New York Heart Association (NYHA) grade 3-4, congestive heart failure, myocardial infarction or cerebrovascular accident within the past 3 months, unstable arrhythmias, or unstable angina or history of multiple cardiovascular events) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).\n\n     Note: Congestive heart failure NYHA II patients can be included if they provide an LVEF \\> 40%.\n  2. Patient with current or history of CNS lymphoma.\n  3. Patient with uncontrolled severe infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus \\[EBV\\], cytomegalovirus \\[CMV\\], hepatitis B, hepatitis C, and HIV\\], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.\n\n     Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n  4. Patient with current \\> Grade 1 peripheral neuropathy.\n  5. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment\n  6. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.\n  7. Known hypersensitivity to hamster ovary (CHO) cell products or to any component of the Zuberitamab, polatuzumab vedotin, obinutuzumab, or glofitamab and\u002For to the contrast agents used in the study.","18 Years",{"count":60,"type":21},40,"INTERVENTIONAL",[63],"PHASE2","This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma.",[66,67,27],"DLBCL - Diffuse Large B Cell Lymphoma","Chemo-free Therapy","NOT_YET_RECRUITING","2025-11-15",{"date":71,"type":42},"2025-11-19",{"date":73,"type":21},"2026-01-15",{"date":75,"type":21},"2028-09-15",{"name":77,"class":49},"Li Zhiming",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":61,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100599579","phase-2-a-phase-ii-randomized-trial-of-neoadjuvant-ivonescimab-or-penpulimab-plus-chemotherapy-in-resectable-nsclc-100599579","NCT07086326","A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC","A Prospective, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Ivonescimab Combined With Chemotherapy Versus Penpulimab Combined With Chemotherapy for Neoadjuvant Treatment of Non-small Cell Lung Cancer (NSCLC)","NEOINSPIRE","Inclusion Criteria:\n\n1. Voluntarily sign the written Informed Consent Form (ICF) and consent to receive curative surgical treatment.\n2. Participants must be aged ≥ 18 years, regardless of gender.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status Score is 0-1.\n4. Histologically confirmed resectable Stage IIA-IIIB (N2) non-small cell lung cancer (NSCLC) according to the 9th edition of the TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).\n5. Prior to study enrollment, subjects must be evaluated by an attending thoracic surgeon responsible for the surgery to verify eligibility for R0 resection with curative intent.\n6. NSCLC appears solid or subsolid (not purely ground-glass opacity \\[GGO\\]) on CT scan. For subsolid lesions, tumor size (i.e., clinical T stage) should be based solely on the solid component without measuring the GGO portion.\n7. Normal pulmonary function test results.\n8. At least one measurable lesion according to RECIST v1.1, amenable to repeated accurate measurements.\n9. Adequate cardiac function.\n10. Laboratory values obtained during screening or within ≤14 days prior to randomization indicate adequate organ function.\n11. For patients planned to receive cisplatin: No hearing impairment.\n12. Women of childbearing potential must have a negative pregnancy test result within 3 days before first treatment; all subjects (male and female) must agree to use appropriate contraceptive methods during the study.\n\nExclusion Criteria:\n\n1. Patients with large cell neuroendocrine carcinoma (LCNEC) or NSCLC mixed with small cell lung cancer components;\n2. Presence of locally advanced unresectable disease (any stage) or metastatic disease (Stage IV). Subjects with contralateral mediastinal lymph node involvement confirmed by PET-CT scan.\n3. NSCLC diagnosed with EGFR-sensitive mutations or ALK gene translocation. For non-squamous cell carcinoma subjects (including NSCLC with unclear pathology), tumor tissue-based EGFR and ALK testing results must be provided. If EGFR\u002FALK status is unknown, testing must be performed prior to enrollment. For squamous NSCLC subjects, EGFR\u002FALK testing is not required during screening if status is unknown.\n4. Any prior systemic or local anti-tumor therapy for NSCLC;\n5. Concurrent enrollment in another clinical trial;\n6. History of other malignancies (excluding NSCLC) within 3 years prior to randomization;\n7. Active autoimmune disease requiring systemic treatment within 2 years prior to randomization;\n8. History of major diseases within 1 year prior to randomization;\n9. Severe cardiovascular risk factors;\n10. History of significant bleeding diathesis or coagulation disorders; clinically significant bleeding symptoms (including but not limited to gastrointestinal hemorrhage, hemoptysis ≥1 teaspoon of fresh blood\u002Fclots or pure hemoptysis without sputum, minor blood-tinged sputum allowed; excluding epistaxis and retracted blood-tinged nasal discharge) within 4 weeks prior to randomization;\n11. Any other conditions deemed unsuitable for enrollment by the investigator.",{"count":88,"type":21},164,[63],"This is a randomized, open-label, multicenter phase II study. The trial plans to enroll 164 subjects with resectable stage IIA-IIIB (N2) NSCLC. Participants will be randomized 1:1 into either the ivonescimab plus chemotherapy or penpulimab plus chemotherapy treatment arm. After 3-4 cycles of neoadjuvant therapy, surgical resection will be performed. The primary objective is to compare the pathological complete response (pCR) rate assessed by local pathologists between ivonescimab-based and penpulimab-based chemo-immunotherapy regimens in the neoadjuvant treatment of resectable NSCLC.",[92,93,94,95,27],"NSCLC","Neoadjuvant Therapy","Immunotherapy","AK112","2025-07-17",{"date":98,"type":42},"2025-07-25",{"date":100,"type":21},"2025-07-31",{"date":102,"type":21},"2027-12-30",{"name":104,"class":49},"Yang Fan, MD",5,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":61,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":4},"100588855","phase-2-comparison-of-neoadjuvant-cadonilimab-versus-chemotherapy-combined-with-pd-1-in-the-treatment-of-resectable-non-small-cell-lung-cancer-with-high-pd-l1-expression-a-single-center-randomized-exploratory-clinical-study-100588855","NCT06946836","Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Cell Lung Cancer With High PD-L1 Expression: A Single-Center, Randomized, Exploratory Clinical Study","Neoadjuvant","Inclusion Criteria:\n\n* The patient shall sign the Informed Consent Form.\n\n  1. Aged 18 ≥ years.\n  2. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IB-IIIA confirmed by imageological examinations (CT, PET-CT or EBUS) and Treatment-naïve for relevant antitumor therapy .\n  3. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.\n  4. Life expectancy is at least 12 weeks.\n  5. At least 1 measurable lesion according to RECIST 1.1.\n  6. Patients with good function of other main organs (liver, kidney, blood system, etc.)\n  7. Patients with lung function can tolerate surgery;\n  8. Without systematic metastasis (including M1a, M1b and M1c);\n  9. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.\n  10. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later).\n\nExclusion Criteria:\n\n* 1.Histology suggestive of small cell component and Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 4. Participants who are allergic to the test drug or any auxiliary materials; 5. Participants with Interstitial lung disease currently; 6. Participants with active hepatitis B, hepatitis C or HIV; 7. Pregnant or lactating women; 8. Participants suffering from nervous system diseases or mental dieases that cannot cooperate; 9.Participated in another therapeutic clinical study; Other factors that researchers think it is not suitable for enrollment.",{"count":114,"type":21},80,[63],"The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.",[118,27,93],"Resectable Non-small Cell Lung Cancer",[120,121,122],"Resectable non-small cell lung cancer","bispecific antibody","Neoadjuvant therapy","2025-04-19",{"date":125,"type":42},"2025-04-27",{"date":127,"type":21},"2025-04-21",{"date":129,"type":21},"2031-05-11",{"name":131,"class":49},"Shanghai Pulmonary Hospital, Shanghai, China"]