[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":261},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,40,63,85,110,133,153,175,196,218,239],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100622598","phase-3-clinical-study-on-the-efficacy-and-safety-of-lm-302-injection-combined-with-tislelizumab-and-tislelizumab-combined-chemotherapy-for-the-treatment-of-gastric-or-gastroesophageal-junction-adenocarcinoma-100622598",false,"NCT07385703","Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.","A Randomized, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any systemic treatment:\n\n  * Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination chemotherapy regimen and have not developed distant metastasis or local recurrence within 6 months after completion of treatment can be included.\n  * The calculation of a 6-month interval is defined as recurrence within the same date range after 6 months. For example, if the end date of the last treatment is January 1, the 6-month period from that date refers to January 1 to July 1 (including July 1). Alternatively, if the end date of the last treatment is August 31, the 6-month period from that date refers to August 31 to February 28 (or February 29 in leap years).\n* Archived specimens or fresh tumor tissue specimens from ≤3 years ago must be provided for CLDN18.2 and PD-L1 testing (PD-L1 results are not a condition for enrollment). When multiple samples are present, the most recent accessible and qualified sample must be provided. After confirmation by the central laboratory, tumor tissue with positive CLDN18.2 expression is defined as ≥25% tumor cell membrane staining intensity 2+ \\& 3+. For patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on platinum-containing combination chemotherapy regimens, newly obtained tissue from recurrent or metastatic lesions must be provided for CLDN18.2 and PD-L1 testing.\n* A negative report on the expression detection of human epidermal growth factor receptor-2 (HER2) in tumor tissue must be provided. The definition of HER2 negative expression is ImmunoHistoChemistry (IHC) score 0\u002F1+, IHC score 2+, and fluorescence in situ hybridization (FISH) negative.\n* According to the RECIST 1.1 evaluation criteria, there must be at least one measurable lesion.\n* Expected survival duration ≥ 3 months.\n* According to the Eastern Cooperative Oncology Group (ECOG) standards, the physical performance status score is 0 or 1.\n* Good organ function: a. Bone marrow reserve: Platelets (PLT) ≥ 100×10\\^9\u002FL, absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL, Hemoglobin (Hb) ≥ 90 g\u002FL (no blood transfusion or supportive treatment such as colony-stimulating factors within 14 days prior to hematology parameter examination during the screening period); b. Coagulation function: International normalized ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5×upper limit of normal (ULN); c. Liver function: Total bilirubin ≤ 1.5×ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤ 2.5×ULN (if there is liver metastasis, then ALT and AST ≤ 5×ULN) and Albumin (ALB) ≥ 30 g\u002FL; d. Renal function: Creatinine clearance rate ≥ 50 mL\u002Fmin (calculated according to the Cockcroft-Gault formula); e. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QT interval (QTcF) ≤ 470 ms for females and ≤ 450 ms for males.\n* Women of childbearing age must have a negative blood pregnancy test within 7 days before administration; any fertile male and female subjects must agree to use highly effective contraception throughout the study medication period and for 7 months after the last dose of the study. Males must agree to refrain from donating sperm during the study period and for 7 months after the last dose of the study. Females must agree to refrain from breastfeeding during the study period.\n\nExclusion Criteria:\n\n* Other pathological types confirmed by histopathology, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.\n* There are gastric cancer lesions confirmed by imaging that are accompanied by cavities or necrosis, and are closely related to major blood vessels, and are assessed by the researchers as posing a high risk of major bleeding.\n* Patients with known central nervous system (CNS) metastases. Patients with non-meningeal, midbrain, pontine, or spinal cord metastases who are judged by the investigator to have stable brain metastases can be enrolled. Stable brain metastases are defined as patients whose brain metastases have undergone treatment and the condition of the metastases has stabilized (brain imaging examination at least 28 days before randomization shows stable lesions, no neurological symptoms, and no immediate need for local or systemic treatment within 14 days before randomization), with no evidence of new or previously existing brain metastases enlarging.\n* Clinically uncontrollable third-space effusion, such as moderate or greater volume, requiring long-term catheterization, previous history of intestinal obstruction or paralysis, compartmented ascites, undergoing or planning to undergo local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy) within 14 days prior to screening, or significant increase within 2 weeks after local treatment, meeting any of the above criteria or deemed unsuitable for enrollment by the investigator.\n* Patients with symptomatic spinal cord compression, or those who are expected to develop symptoms of spinal cord compression if left untreated; or for patients with previously diagnosed and treated spinal cord compression, there is no evidence indicating that the disease was clinically stable for ≥4 weeks before the first study drug administration; except for patients with asymptomatic spinal cord compression indicated by imaging, who are assessed as stable by a specialist and do not require treatment for spinal cord compression at this time.\n* Accompanied by severe peritoneal metastasis, the main manifestations are: clinically significant intestinal obstruction; barium enema indicating small intestinal stenosis.\n* History of gastrointestinal perforation or gastrointestinal fistula within the previous 6 months. If the perforation or fistula has been treated through resection or repair surgery, and the condition is assessed by the investigator as having been cured or controlled, participation in the study is permissible.\n* Poorly controlled tumor-related pain:\n\n  * For patients requiring analgesic treatment, a stable dosage of treatment must be established before participating in the study.\n  * Symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastasis causing nerve damage) should be treated before enrollment.\n  * Before enrollment, if appropriate, consideration should be given to local treatment for asymptomatic metastatic lesions that may lead to functional deficits or intractable pain due to further growth (e.g., epidural metastasis not currently associated with spinal cord compression).\n* Patients with a body weight of less than 35kg or a body weight loss of more than 10% within 2 months prior to signing the informed consent form.\n\nExclusion criteria for comorbidities or concomitant conditions:\n\n* History of malignancy other than Gastric Cancer (GC)\u002FGastroEsophageal Junction adenocarcinoma (GEJ) adenocarcinoma within 2 years prior to randomization, with the following exceptions: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, squamous cell carcinoma of the skin, etc., which have been completely cured and treated.\n* History of autoimmune diseases, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following conditions are excluded: • Subjects with autoimmune-related hypothyroidism who are receiving stable-dose thyroid hormone replacement therapy.\n\n  * Subjects with type 1 diabetes who are well-controlled under a stable insulin treatment regimen.\n  * Only subjects with skin autoimmune diseases that do not require systemic treatment (such as vitiligo, alopecia, psoriasis, or eczema).\n  * Subjects who have recovered from childhood asthma and do not require any intervention in adulthood.\n  * Subjects whose relevant diseases, as assessed by the researchers, are unlikely to recur without external triggers.\n* Patients who have previously undergone allogeneic bone marrow transplantation or solid organ transplantation.\n* Patients with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  * Severe cardiac rhythm or conduction abnormalities, such as arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, left bundle branch block, prolonged QRS complex, etc.;\n  * Patients with thromboembolic events requiring therapeutic anticoagulation, or those with venous filters;\n  * Patients with heart failure of New York Heart Association (NYHA) class III or IV;\n  * Patients who have experienced acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular and cerebrovascular events of grade 3 or above within the previous 6 months prior to randomization.\n  * Have a history of myocarditis or cardiomyopathy.\n* For individuals infected with human immunodeficiency virus (HIV) and those with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the following conditions are allowed for enrollment: • Patients who are HBsAg positive, with or without HBcAb positivity, and have HBV DNA \\\u003C 500 IU\u002FmL or below the lower limit of the reference value set by the research center, and who, based on clinical treatment, manifestations, and other factors, are judged by the investigator to have no active infection; • Patients who are HCV antibody positive but HCV RNA negative.\n* Subjects with known active syphilis infection.\n* Individuals who are unable to control themselves or have severe illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks before the first dose, and interstitial pneumonia\u002Flung disease requiring intervention during screening.\n* Subjects with known active tuberculosis. For patients suspected of having active tuberculosis, a comprehensive evaluation should be conducted based on chest imaging, sputum smear\u002Fculture, or molecular testing results, as well as clinical symptoms and signs, to make a definitive diagnosis.\n* Currently present peripheral sensory or motor neuropathy of ≥ grade 2.\n* Subjects who received systemic corticosteroids (\\>10mg\u002Fd prednisone equivalent) or other systemic immunosuppressants (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs \\[anti-Tumor Necrosis Factor (TNF)\\] within 2 weeks prior to the first study drug administration.\n\n  * Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed;\n  * Patients receiving acute low-dose systemic immunosuppressive drugs (e.g., single-dose dexamethasone for nausea);\n  * Patients requiring baseline and subsequent MRI\u002FCT tumor assessments who have previously experienced allergic reactions to intravenous contrast agents may receive prophylactic steroids;\n  * Inhaled corticosteroids are allowed for the treatment of chronic obstructive pulmonary disease, hydrocortisone for the treatment of orthostatic hypotension, and low-dose corticosteroid hormone maintenance therapy for adrenal insufficiency.\n* There are factors that affect the application and absorption of oral medications, such as dysphagia, clinically uncontrollable persistent and recurrent vomiting (such as caused by gastric outlet obstruction), intestinal obstruction, and chronic diarrhea. 21. Within 28 days before randomization, there was uncontrollable\u002Fsevere gastrointestinal bleeding, active peptic ulcer, or active gastrointestinal inflammation\u002Finfectious diseases (such as active diverticulitis, abdominal abscess). Subjects who have not undergone radical surgical resection of the primary lesion must undergo fecal occult blood testing before enrollment. If the result is positive, further evaluation, including but not limited to gastroscopy, is required before medication administration to confirm the presence of active bleeding from the lesion and assess the risk of bleeding.\n* The adverse reactions from previous anti-tumor treatment within the 14 days prior to randomization have not yet recovered to a level of ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grading system (excluding toxicities that the investigator deems to pose no safety risk, are asymptomatic, or are controllable with stable medication, such as hair loss, long-term toxicity caused by radiotherapy, and other toxicities that are ≤ grade 2).\n* Have a history of allergy to LM-302, Ticagrelor, any control drug, or its excipients.\n* Individuals with known mental illnesses or disorders that may affect trial compliance.\n\nExclusion criteria related to drug treatment:\n\n* Within 28 days prior to randomization, the subject is currently participating or has previously participated in any investigational drug study, or has used an investigational device within 28 days. Subjects who have entered the follow-up period of an investigational drug study and have not used the investigational drug for ≥28 days since the last use may meet the inclusion criteria for this study.\n* Previously received targeted therapy targeting CLDN18.2, such as antibody-drug conjugate (ADC) therapy, antibody therapy, and chimeric antigen receptor T-cell (CAR-T) therapy; previously received ADC therapy using small molecule toxin Monomethyl auristatin E (MMAE).\n* Subjects who have received palliative local treatment (such as radiotherapy or surgery) for non-target lesions within 2 weeks prior to the first dose, or who have previously received radiotherapy for locally advanced unresectable or metastatic gastric cancer or GEJ adenocarcinoma and have not recovered from toxicity within 2 weeks prior to randomization.\n* Within the first 2 weeks before randomization, patients received systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications, or with Chinese herbal medicine, or with drugs with immune regulatory effects (including thymosin, interferon, interleukin, etc.).\n* Having undergone or planning to undergo major surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within the 28 days prior to randomization or during the study period.\n* Use of strong inhibitors\u002Fstrong inducers of CYP3A4 within 14 days before randomization;\n* Vaccination with any live vaccine or attenuated live vaccine within 28 days before randomization.\n* Other situations where the researcher deems it inappropriate for participation in this study.","ALL","18 Years",{"count":19,"type":20},752,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity.",[26],"Adenocarcinoma","RECRUITING","2026-06-23",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":31},"2026-04-15",{"date":35,"type":20},"2030-05",{"name":37,"class":38},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","INDUSTRY",106,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100579860","phase-3-tqc2731-clinical-trial-for-the-treatment-of-severe-asthma-with-injection-100579860","NCT06829784","TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection","A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injections in Patients With Poorly Controlled Severe Asthma","Inclusion Criteria:\n\n* Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial;\n* Age 18 \\~ 75 years old, gender is not limited;\n* Documented physician diagnosis of asthma at least 12 months prior to Visit 1;\n* Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1;\n* There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1;\n* There must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; For subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment.\n* Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed.\n\nExclusion Criteria:\n\n* Have a clinically significant lung disease other than asthma；\n* Pre-existing autoimmune disease;\n* A history of known or suspected immunosuppression, including a history of invasive opportunistic infections;\n* Any disease that has not been determined to be stable by the investigator；\n* Cancer history: Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. Patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study.\n* Current smoker or smoking history ≥10 pack-years (former smokers with smoking history \\\u003C10 pack-years had quit smoking less than 6 months before interview 1);\n* Other factors determined by the investigator that subjects were not suitable to participate in the study.","75 Years",{"count":49,"type":20},660,[23],"This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.",[53],"Asthma","2026-06-15",{"date":56,"type":31},"2026-06-17",{"date":58,"type":31},"2025-03-21",{"date":60,"type":20},"2028-03",{"name":37,"class":38},101,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100605702","phase-3-clinical-trial-comparing-tqb2868-injection-combined-with-anlotinib-hydrochloride-capsules-with-placebo-combined-with-chemotherapy-as-first-line-treatment-for-metastatic-pancreatic-ductal-adenocarcinoma-mpdac-100605702","NCT07165951","Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)","A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules to Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)","Inclusion Criteria:\n\n1. The subjects voluntarily joined this study, signed the Informed Consent Form (ICF), and showed good compliance;\n2. On the date of signing the ICF, aged between 18 and 75 years old (inclusive);\n3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by tissue or cytology;\n4. According to the American Joint Commission on Cancer (AJCC) 8th Edition Tumor, Node, Metastasis (TNM) staging system for pancreatic cancer, patients with stage IV metastatic pancreatic cancer;\n5. Have not received any systemic anti-tumor treatment or investigational drug therapy; If receiving neoadjuvant\u002Fadjuvant therapy, the time interval between the last administration and recurrence\u002Fprogression must be ≥ 6 months, and the toxicity related to anti-tumor therapy has recovered to ≤ level 1 or the toxicity level specified in the inclusion criteria (excluding hair loss); According to RECIST v1.1, there is at least one measurable lesion. If the lesion has undergone local treatment (radiotherapy, ablation, interventional therapy, etc.) in the past, it must be clearly proven to have progressed in accordance with RECIST v1.1 before it can be considered a measurable lesion;\n\n7\\. Eastern Cooperative Oncology Group (ECOG) score from 0 to 1; Expected survival is greater than 12 weeks; 9. The laboratory inspection meets the protocol standards; 10. Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, and have a negative serum test within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period;\n\nExclusion Criteria:\n\n1. Have had or currently have other malignant tumors within the past 5 years prior to the first use of medication;\n2. There are various factors that affect intravenous injection, venous blood collection diseases, or oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);\n3. Adverse reactions from previous treatments have not recovered to NCI CTCAE v5.0 score ≤ 1, except for toxicity that has been determined by researchers to have no safety risks, such as grade 2 hair loss, grade 2 peripheral neurotoxicity, non clinically significant, and asymptomatic laboratory abnormalities;\n4. Those who have received major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks before the first medication, or have long-term untreated wounds or fractures;\n5. Subjects who experience any bleeding or bleeding events ≥ NCI CTCAE v5.0 grade 3 within 4 weeks prior to the first administration;\n6. Individuals who have experienced arterial\u002Fvenous thrombotic events within 6 months prior to the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial vein thrombosis is not considered \"severe\" thromboembolism);\n7. hepatitis B virus (HBV) infected individuals cannot receive regular antiviral treatment throughout the entire process; HCV infected individuals (HCV Ab or HCV RNA positive): Researchers determine that they are in an unstable state or need to continue antiviral treatment. Regular antiviral treatment cannot be accepted during the study;\n8. Active syphilis infected individuals who require treatment;\n9. History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;\n10. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;\n11. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;\n12. Subjects with any severe and\u002For uncontrolled illnesses;\n13. Subjects who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppression and continue to use it within 7 days prior to the first dose (excluding corticosteroids with a daily dose of\\\u003C10 mg prednisone or other therapeutic hormones);\n14. Tumor related symptoms are difficult to control;\n15. Known to be allergic to the components of research drug excipients;\n16. Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;\n17. Pregnant or breastfeeding subjects; According to the judgment of the researchers, there are serious situations that pose a threat to the safety of the subjects or affect their ability to complete the study.",{"count":71,"type":20},566,[23],"This study adopts a randomized, open label, placebo-controlled, multicenter trial design. OS was the primary endpoint, and eligible subjects were randomly divided into 1:1 groups and received TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy, compared to placebo combined with chemotherapy.",[75],"Metastatic Pancreatic Ductal Adenocarcinoma","2026-05-28",{"date":78,"type":31},"2026-05-29",{"date":80,"type":31},"2025-12-02",{"date":82,"type":20},"2028-12",{"name":37,"class":38},71,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100637237","phase-1-treatment-of-recurrentmetastatic-head-and-neck-cancer-100637237","NCT07601204","Treatment of Recurrent\u002FMetastatic Head and Neck Cancer","Phase Ib\u002FII Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of TQB2922 Injection (Subcutaneous) in the Treatment of Recurrent\u002FMetastatic Head and Neck Cancer","Inclusion Criteria:\n\n* The subject voluntarily enrolls in the study, signs the informed consent form, and has good compliance.\n* Aged 18 to 75 years inclusive (calculated on the date of informed consent signing).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Expected survival \\> 12 weeks.\n* Subjects with histologically or cytologically confirmed recurrent\u002Fmetastatic head and neck cancer (R\u002FM HNC) and no indication for curative local therapy.head and neck cancer (HNC)\n* At least one measurable lesion per RECIST 1.1 criteria. If the target lesion is within the prior radiotherapy field, the lesion must be confirmed as progressive disease.\n* Adequate major organ function, meeting the following laboratory criteria (no blood transfusion within 14 days prior to screening; no hematopoietic growth factors or other corrective medications administered within 7 days prior to screening):\n\n  * Hemoglobin (HGB) ≥ 90 g\u002FL;\n  * Absolute neutrophil count (NEUT) ≥ 1.5×10⁹\u002FL;\n  * Platelet count (PLT) ≥ 100×10⁹\u002FL;\n  * Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); ≤ 2.0×ULN in subjects with liver metastasis;\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; ≤ 5.0×ULN in subjects with liver metastasis;\n  * Creatinine clearance (CCR) ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula). For subjects not receiving platinum-containing chemotherapy, serum creatinine (Cr) ≤ 1.3×ULN is also acceptable.\n  * Serum albumin ≥ 30 g\u002FL;\n  * Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (in subjects not receiving anticoagulant therapy).\n* Echocardiographic assessment: left ventricular ejection fraction (LVEF) ≥ 50%.\n* Females of childbearing potential agree to use effective contraception during the study and for 6 months after study completion; serum or urine pregnancy test must be negative within 7 days prior to enrollment. Males agree to use effective contraception during the study and for 6 months after study completion (see Section 5.5 for details).\n\nAdditional criteria for Expansion Cohort 1 and Cohort 2:\n\n* Has received at least one line of systemic therapy for recurrent\u002Fmetastatic disease, including platinum-based chemotherapy and anti-programmed cell death protein 1 \u002F programmed cell death ligand 1 (anti-PD-1\u002FL1) therapy.\n\nSystemic therapy administered as part of multimodal treatment for locally advanced disease (including neoadjuvant\u002Finduction, concurrent, adjuvant\u002Fconsolidation therapy), with disease recurrence or progression during chemotherapy\u002Fimmunotherapy or within 6 months after the last dose, shall be defined as first-line chemotherapy\u002Fimmunotherapy failure.\n\n* No prior exposure to paclitaxel and its novel formulations (e.g., albumin-bound paclitaxel) (Cohort 2 only).\n\nAdditional criteria for Expansion Cohort 3\n\n* No prior systemic therapy for recurrent\u002Fmetastatic disease. Systemic therapy as part of multimodal treatment for locally advanced disease (including induction\u002Fneoadjuvant therapy, concurrent systemic therapy with curative radiotherapy, adjuvant\u002Fconsolidation therapy) is excluded, provided that the interval from completion of such therapy to disease recurrence\u002Fprogression exceeds 6 months.\n\nExclusion Criteria:\n\n* Current or history of other malignant tumors. The following two conditions are allowed for enrollment:\n\nOther malignant tumors treated with surgery alone with continuous 5-year disease-free survival (DFS); cured carcinoma in situ of cervix, non-melanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invading basement membrane)\\].\n\n* Diseases that interfere with subcutaneous injection or venous blood collection.\n* Adverse reactions from prior treatment have not recovered to ≤Grade 1 per CTCAE Version 6.0, except Grade 2 alopecia, Grade 2 peripheral neurotoxicity (Cohort 1 only), Grade 2 anemia, non-clinically significant asymptomatic Grade 2 laboratory abnormalities, hypothyroidism stabilized by hormone replacement therapy, and other toxicities deemed to have no safety risk by the investigator.\n* Major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose, or planned major surgery during the study treatment period (excluding protocol-specified surgeries); or unhealed wounds or fractures for a long time.\n\nMajor surgery is defined as Grade 3 or above surgeries in the 2022 National Surgery Classification Catalogue.\n\n* Any bleeding event ≥Grade 3 per CTCAE within 4 weeks prior to the first dose.\n* Arterial\u002Fvenous thromboembolic events within 6 months prior to the first dose, including cerebrovascular accidents (including transient ischemic attack, excluding lacunar cerebral infarction). Implantable venous port\u002Fcatheter-related thrombosis or superficial venous thrombosis shall not be regarded as \"severe\" thromboembolism); deep venous thrombosis and pulmonary embolism.\n* Active and poorly controlled viral hepatitis. Subjects meeting the following criteria may undergo screening:\n\nHBsAg-positive subjects must have Hepatitis B Virus Deoxyribonucleic Acid (HBV) DNA \\\u003C500 IU\u002FmL (or 2500 copies\u002FmL), and agree to receive anti-HBV therapy throughout the study.\n\nHCV-infected subjects (HCV Ab or HCV RNA positive): HCV viral RNA ≤upper limit of normal, and continue approved antiviral therapy during the study.\n\n* Active syphilis requiring treatment.\n* Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia\u002Fradiation pneumonitis requiring treatment, active pneumonia with obvious clinical symptoms; history of interstitial lung disease (ILD) requiring previous treatment, or current interstitial lung disease.\n* History of psychoactive substance abuse without abstinence, or mental disorders.\n* Planned or prior allogeneic bone marrow transplantation or solid organ transplantation.\n* History of hepatic encephalopathy.\n* Severe cardiovascular diseases, including any of the following:\n\n  * Cardiac insufficiency ≥New York Heart Association (NYHA) Class II, or echocardiography showing left ventricular ejection fraction (LVEF) \\\u003C50%.\n  * History of clinically significant ventricular arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes), or arrhythmia requiring continuous antiarrhythmic medication. Subjects with stable atrial fibrillation controlled by β-blockers alone may be enrolled after investigator's assessment.\n  * Unstable angina pectoris.\n  * Myocardial infarction within 12 months. Subjects who received interventional treatment more than 6 months ago without sequelae may be enrolled.\n  * Corrected QT interval (QTc): \\>450 ms in males, \\>470 ms in females. If QTc is abnormal, three consecutive measurements at an interval \\>2 minutes shall be performed and the average value adopted. Correction methods include Fridericia formula or Bazett formula.\n  * History or family history of congenital long QT syndrome.\n* Active or uncontrolled severe infection (≥CTCAE Grade 2 infection).\n* Renal failure requiring hemodialysis or peritoneal dialysis.\n* History of immunodeficiency, including HIV positivity, or other acquired\u002Fcongenital immunodeficiency diseases.\n* Uncontrolled autoimmune diseases requiring immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes, and still requiring such treatment within 7 days prior to the first dose.\n\nExclusion does not apply to subjects receiving prednisone \\\u003C10 mg daily or equivalent dose of other corticosteroids.\n\n* Epilepsy requiring treatment.\n* Poorly controlled diabetes \\[fasting blood glucose (FBG)\\>10 mmol\u002FL\\].\n* Tumor-related conditions and prior therapies:\n\n  * Received chemotherapy, immunotherapy, small-molecule targeted therapy within 3 weeks prior to the first dose, or still within 5 half-lives of the drug (whichever is longer). The washout period is calculated from the date of the last treatment.\n\nPrior local radiotherapy is allowed if: radiotherapy completed \\>4 weeks prior to study treatment initiation (\\>2 weeks for brain radiotherapy); target lesion selected in this study is outside the radiotherapy field; or target lesion within radiotherapy field with confirmed progression.\n\n* Received proprietary Chinese medicines with anti-tumor indications specified in National Medical Products Administration approved drug instructions within 1 week prior to the first dose (including Compound Mylabris Capsule, Kang'ai Injection, Kanglaite Capsule\u002FInjection, Aidi Injection, Brucea Javanica Oil Injection\u002FCapsule, Xiaoaiping Tablets\u002FInjection, Huachansu Capsule, etc.).\n* Imaging (CT\u002FMRI) shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade major blood vessels and cause fatal massive hemorrhage during subsequent study treatment.\n* Uncontrolled recurrent pleural effusion, pericardial effusion or moderate to severe ascites requiring repeated drainage (as assessed by investigator).\n* Known spinal cord compression, meningeal metastasis\u002Fcarcinomatous meningitis, brain metastasis with symptoms, or brain metastasis with symptomatic\u002Fradiographic control duration \\\u003C4 weeks; still requiring steroids or dehydrating agents within 2 weeks prior to study treatment initiation.\n\nSubjects with newly diagnosed or progressive brain metastasis at screening shall be re-examined after at least 4 weeks to confirm stability.\n\n* Known hypersensitivity to study drug or excipients.\n* Received more than 2 lines of systemic therapy for recurrent\u002Fmetastatic disease (Cohort 1 and Cohort 2).\n* Prior treatment with EGFR-targeted antibodies\u002FAntibody-Drug Conjugates (ADCs). Exclusion does not apply to subjects who received cetuximab or nimotuzumab during curative radiotherapy for locally advanced disease, with disease recurrence\u002Fprogression occurring \\>6 months after completion of curative radiotherapy and the last dose.\n* Prior treatment with more than one immune checkpoint inhibitor, or prior Transforming Growth Factor Beta targeted therapy (Cohort 3).\n* Participated in another anti-tumor clinical trial and received investigational drugs within 4 weeks prior to the first dose.\n* Conditions judged by the investigator to pose serious risks to subject safety or impair completion of the study.",{"count":93,"type":20},128,[95,96],"PHASE1","PHASE2","This study is a Phase Ib\u002FII study of TQB2922 injection (subcutaneous). In the Phase Ib stage, a 3+3 dose-escalation design was used to determine the RP2D and pharmacokinetic characteristics of TQB2922 injection (subcutaneous) administered once every 3 weeks in subjects with R\u002FM HNC. The Phase II stage explored the efficacy and safety of TQB2922 (subcutaneous) as monotherapy or in combination therapy in subjects with R\u002FM HNC.",[99],"Recurrent\u002FMetastatic Head and Neck Cancer","NOT_YET_RECRUITING","2026-05-17",{"date":103,"type":31},"2026-05-22",{"date":105,"type":20},"2026-06",{"date":107,"type":20},"2030-12",{"name":37,"class":38},10,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100613402","phase-1-assessment-of-the-efficacy-and-safety-of-injectable-tqb2934-subcutaneous-injection-in-systemic-light-chain-amyloidosis-patients-100613402","NCT07266116","Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients","A Phase Ib\u002FII Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQB2934 for Injection in Subjects With Systemic Light Chain Amyloidosis","Inclusion Criteria:\n\n* The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance;\n* Aged 18 to 80 years old, with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, and an expected survival of more than 12 weeks;\n* Systemic light chain amyloidosis with diagnostic records (i.e., primary light chain amyloidosis);\n* Presence of measurable lesions;\n* At least one organ involved;\n* Have previously received at least one line of systemic treatment, and recurred and progressed after the remission of the last line treatment;\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≤ 8500 ng\u002FL;\n* The corresponding organ function conforms to the protocol requirements;\n* Women of childbearing age should agree to use contraception during the study period and for 6 months after its completion; they must have a negative serum pregnancy test within 7 days before enrollment in the study and must be non-lactating subjects; men should agree to use contraception during the study period and for 6 months after its completion.\n\nExclusion Criteria:\n\n* Diagnosed with other types of amyloidosis, active plasma cell leukemia, active multiple myeloma, etc.\n* Have received allogeneic hematopoietic stem cell transplantation within 1 year prior to the first dose, or have received autologous hematopoietic stem cell transplantation within 12 weeks prior to the first dose;\n* Previously received treatment with drugs targeting the same target;\n* Within 4 weeks prior to the first dose, the patient has received a cumulative dose of dexamethasone \\>160 mg or an equivalent dose of other glucocorticoids, or within 3 weeks prior to the first dose, the patient has received targeted therapy, cytotoxic drugs, or any antibody therapy, or within 2 weeks prior to the first dose, the patient has received proteasome inhibitor therapy or radiotherapy, or within 1 week prior to the first dose, the patient has received immunomodulator therapy;\n* Those who have received treatment with traditional Chinese patent medicines and simple preparations with clear anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the first administration;\n* Those who have received attenuated live vaccine within 4 weeks before the first dose or plan to receive attenuated live vaccine during the study period;\n* Individuals with a history of severe allergies of unknown cause, or known allergies to monoclonal antibody drugs or exogenous human immunoglobulins, or known allergies to the excipients in injectable TQB2934 or pharmaceutical preparations;\n* Having had or currently suffering from other malignant tumors within 3 years before the first medication;\n* Unresolved toxic reactions above Common Terminology Criteria (CTC) AE Grade 1 caused by any previous treatment;\n* Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period within 4 weeks before the first dose of medication;\n* Arterial\u002Fvenous thromboembolic events occurred within 6 months before the first dose;\n* Individuals with a history of abuse of psychotropic drugs who are unable to quit or who have mental disorders; or intractable seizures that require treatment;\n* Those with unsatisfactory blood pressure control;\n* Patients with poorly controlled diabetes;\n* Patients who have active or uncontrolled severe bacterial, viral, or systemic fungal infections (≥CTC AE Grade 2 infections) within 4 weeks before the first dose of medication;\n* Patients with hepatitis or decompensated liver cirrhosis (Child-Pugh Class B or C);\n* Individuals with active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or clinically symptomatic active pneumonia;\n* Those who have experienced asthma within 2 years before the first medication or currently suffer from asthma or chronic obstructive pulmonary disease;\n* Individuals with significant cardiovascular diseases;\n* Individuals with a history of immune deficiency, or active autoimmune diseases requiring systemic immunosuppressive therapy, etc.\n* Exclude subjects with organ failure unrelated to systemic light-chain (AL) amyloidosis;\n* Subjects deemed unsuitable for enrollment by the researchers.","80 Years",{"count":119,"type":20},70,[95,96],"This study is a clinical trial aimed at the marketing of TQB2934 for injection. The project plans to enroll 70 subjects, including 13-21 subjects in Phase Ib, to evaluate the safety and preliminary efficacy, pharmacokinetic (PK) characteristics, immunogenicity, and pharmacodynamic (PD) of TQB2934 for injection in subjects with systemic light chain amyloidosis, and to determine the recommended Phase II dose (RP2D). The Phase II plan involves enrolling 49 subjects, aiming to demonstrate that in adult subjects with relapsed\u002Frefractory systemic light chain amyloidosis who have previously received treatment with daratumumab and bortezomib, TQB2934 for injection significantly improves the hematological complete response (CR) rate compared to historical controls. The primary endpoint is the optimal hematological CR rate.",[123],"Systemic Light Chain Amyloidosis","2026-05-07",{"date":126,"type":31},"2026-05-08",{"date":128,"type":31},"2025-12-26",{"date":130,"type":20},"2029-11",{"name":37,"class":38},27,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":5},"100612986","phase-1-clinical-trial-of-tqb2922-injection-subcutaneous-injection-in-patients-with-advanced-cancers-100612986","NCT07260708","Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers","A Phase I Clinical Study to Evaluate The Safety and Pharmacokinetics of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers","Inclusion Criteria:\n\n* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；\n* 18-75 yeas old；\n* Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;\n* Expected survival of more than 12 weeks；\n* Histologically or cytologically diagnosed with advanced non-squamous non-small cell lung cancer\n* Subjects in the monotherapy introduction stage need to have received standard treatment or lack effective treatment.\n* There must be at least one measurable lesion within the radiotherapy area that can be clearly classified as progressive according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) criteria.\n* Major organs are functioning well；\n* Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n* Current concomitant presence of other malignancies within 5 years prior to the first dose；\n* At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.\n* Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.\n* Hyperactive or venous thrombosis events occurred within 6 months before the first administration;\n* Major cardiovascular diseases;\n* Active hepatitis\n* Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders.\n* There was an active infection (≥ Common Terminology Criteria for Adverse Events version 5.0 (CTCAE5.0) score of grade 2) within 2 weeks before the first administration;\n* Patients with renal failure requiring hemodialysis or peritoneal dialysis;\n* Patients who have a history of immune deficiency.\n* Patients who have epilepsy and need treatment;\n* Evidence of a previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial lung disease.\n* Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first treatment.\n* Pregnant or lactating women.\n* There is any serious or uncontrolled systemic disease.",{"count":141,"type":20},42,[95],"This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.",[145],"Advanced Cancers","2026-04-20",{"date":148,"type":31},"2026-04-21",{"date":150,"type":31},"2025-12-16",{"date":82,"type":20},{"name":37,"class":38},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100623609","phase-2-clinical-study-on-tqh2722-injection-combined-with-background-therapy-for-seasonal-allergic-rhinitis-100623609","NCT07398859","Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis","A Multi-center, Open-label, Phase II, Single-arm Clinical Study Evaluating the Safety and Efficacy of TQH2722 Injection Combined With Background Treatment in Subjects With Seasonal Allergic Rhinitis","Inclusion Criteria:\n\n* Aged 18-75, with no gender restrictions.\n* Diagnosed with seasonal allergic rhinitis.\n* Positive allergen test result.\n* The subjects have sufficient exposure to pollen during the pollen season.\n* The subject's medical history indicates that the subject had poor control of Seasonal Allergic Rhinitis (SAR) symptoms during the previous pollen season or the subject was dissatisfied with the subjective symptom control.\n* Screen for subjects who have a morning iTNSS score of ≥4 on the day of screening; at baseline visit, have a morning iTNSS score of ≥4, and have an average rTNSS score of ≥4 over the past 6 days.\n* Good compliance during screening\u002Finduction period.\n* Subjects with comorbid asthma should have stable medication use before the screening period and have their asthma condition assessed as stable by the investigator or specialist.\n* The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance.\n* The subjects and their partners agree to take effective contraceptive measures throughout the entire study period (from the signing of the Informed Consent Form (ICF) to 3 months after the last administration of the trial drug).\n\nExclusion Criteria:\n\n* Any abnormal laboratory test value during the screening period or randomization.\n* Any disease that researchers consider to be unstable and may affect the patient's safety throughout the entire study period, or affect the study results or their interpretation, or hinder the patient's ability to complete the entire study process.\n* Patients with active autoimmune diseases.\n* Known or suspected immunosuppressants.\n* Subjects with active malignant tumors or a history of malignant tumors.\n* Screen for individuals with a history of active tuberculosis within the previous 12 months.\n* During the screening period, there is active hepatitis, or the presence of human immunodeficiency virus antibody (Anti-HIV) positivity, or syphilis treponema antibody (Anti-TP) positivity.\n* Screen for cases diagnosed with helminthic parasitic infections within the previous 6 months, who have not undergone standard treatment or have experienced ineffective standard treatment.\n* Subjects who have received specific medications or undergone any nasal or sinus surgery within the specified timeframe.\n* Intravenous immunoglobulin (IVIG) therapy and\u002For plasma exchange within 30 days before screening.\n* Screen subjects who have used monoamine oxidase inhibitors within the previous 14 days.\n* Initiate allergen immunotherapy within 3 months prior to screening.\n* Screen for individuals who have received attenuated live vaccines within the previous 4 weeks or plan to receive attenuated live vaccines during the study period.\n* Screen for systemic Chinese herbal preparations used for the treatment of AR with short- or medium-acting systemic glucocorticoids within 4 weeks, or screen for long-acting Systemic Corticosteroids (SCS) received within the previous 6 weeks.\n* Suffering from chronic active or acute infection within 2 weeks before screening or during the screening and import period.\n* Patients with concomitant asthma should be excluded if they meet any of the following conditions: a. forced expiratory volume in one second (FEV1) ≤ 50% of the predicted normal value; b. acute exacerbation of asthma within 90 days prior to screening; c. currently using fluticasone propionate at a daily dose of \\>1000 μg\u002Fday or equivalent doses of other inhaled corticosteroids; d. assessed by the investigator or specialist as having unstable asthma.\n* The subject has a concomitant disease that renders them unable to complete the screening period assessment or evaluate the primary efficacy endpoint.\n* Suffering from malignant and benign tumors in the nasal cavity.\n* Subjects with perennial allergic rhinitis (PAR) who are allergic to pet hair.\n* Unable to use nasal corticosteroid sprays or antihistamines.\n* Have a history of systemic allergy to any biological agents.\n* Women who are pregnant or breastfeeding.\n* Individuals who abuse alcohol, use drugs, and have known drug dependency.\n* History of major organ transplantation or hematopoietic stem cell\u002Fbone marrow transplantation.\n* According to the researcher's judgment, there are any medical or psychiatric symptoms that may put the subjects at risk, interfere with their participation in the study, or interfere with the interpretation of the study results.\n* The forced expiratory volume in one second (FEV1) of the subject is less than or equal to 50% of the predicted normal value.\n* Other reasons why the researcher believes it is inappropriate to participate in this trial.",{"count":161,"type":20},300,[96],"This study is a multicenter, open-label, Phase II, single-arm clinical trial, with a planned enrollment of 200 to 300 subjects. Its primary objective is to evaluate the safety and efficacy of TQH2722 injection in the treatment of seasonal allergic rhinitis.",[165],"Seasonal Allergic Rhinitis","2026-03-26",{"date":168,"type":31},"2026-03-27",{"date":170,"type":31},"2026-03-19",{"date":172,"type":20},"2027-03",{"name":37,"class":38},30,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100601189","phase-3-clinical-trial-of-tqc2731-injection-in-patients-with-chronic-sinusitis-and-nasal-polyps-100601189","NCT07107256","Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","Inclusion Criteria:\n\n* Signed informed consent form prior to trial participation, demonstrating full understanding of trial objectives, procedures, and potential adverse reactions.\n* Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.\n* Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the \"Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018)\"\n* At least one prior course of systemic corticosteroids (prednisone 0.5-1 mg\u002Fkg\u002Fday or 15-30 mg\u002Fday or equivalent for minimum 5 days) within 2 years before screening, with persistent bilateral CRSwNP; AND\u002FOR contraindication\u002Fintolerance to systemic corticosteroids; AND\u002FOR prior nasal polyp surgery performed more than 6 months before screening.\n* Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and randomization.\n* Nasal Congestion Score (NCS) ≥2 at screening (daily average) and randomization (weekly average).\n* Persistent symptoms of rhinorrhea and\u002For hyposmia\u002Fanosmia for over 8 weeks prior to screening.\n* 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥30 at screening and randomization.\n* Stable dose of intranasal corticosteroids (INCS) for \\>4 weeks prior to screening (subjects using non-mometasone furoate nasal spray \\[MFNS\\] products must agree to switch to Mometasone Furoate Nasal Spray (MFNS) during the study).\n* Subjects with comorbid asthma must have had stable asthma symptoms for ≥4 weeks prior to screening (if using medications, such as inhaled corticosteroids, the same dose must have been stably maintained for ≥4 weeks before screening, and the dose is assessed to remain stable during the first phase).\n* The evaluation during the lead-in period showed that the medication adherence to intranasal mometasone furoate nasal spray (MFNS) was greater than 70%, and the adherence to daily symptom assessment records in the subjects' electronic logs was also greater than 70%. Note: Days with missing electronic log data were considered non-adherent to this criterion.\n* Agreement to practice effective non-pharmacologic contraception from informed consent until 6 months post-final dose, for subjects\u002Fpartners of childbearing potential.\n\nExclusion Criteria:\n\n* Conditions\u002FDiseases Affecting Efficacy Evaluation\n\n  * Nasal septum deviation causing ≥1 nostril obstruction；\n  * Perforation of the nasal septum\n  * Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks pre-screening or during screening\u002Frun-in periods；\n  * Rhinitis medicamentosa；\n  * Eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), Young's syndrome, Kartagener's syndrome, other ciliary dyskinesia syndromes, or cystic fibrosis；\n  * Suspected or confirmed fungal sinusitis by imaging；\n  * Prior nasal surgery altering lateral wall structure precluding NPS assessment；\n  * Nasal malignancies or benign tumors (e.g., papilloma, hemangioma)；\n* Any intranasal and\u002For sinus surgery (including polypectomy) within 6 months prior to screening.\n* Uncontrolled epistaxis within 2 months prior to screening.\n* Regular use of decongestants (topical or systemic) prior to screening, except for short-term use during endoscopic examinations.\n* Patients who have received any of the following treatments prior to randomization:\n\n  * Treatment with immunosuppressants (including but not limited to: cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate, tacrolimus, Secukinumab) within 8 weeks or 5 half-lives prior to screening (whichever is longer)；\n  * Treatment with any monoclonal antibodies (including but not limited to: benralizumab, mepolizumab, omalizumab, dupilumab, or other similar drugs \\[e.g., TSLP blockers\\]) within 8 weeks or 5 half-lives prior to screening (whichever is longer).\n  * Patients who used medium- or short-acting systemic corticosteroids (SCS, including oral, intravenous, or intramuscular administration), systemic traditional Chinese medicine preparations for treating CRS within 4 weeks prior to screening, or received long-acting SCS (e.g., triamcinolone acetonide injection) within 6 weeks prior to screening, or who plan to receive the aforementioned medications during the study period.\n  * Use of corticosteroid-eluting nasal stents within 6 months prior to screening;\n  * Treatment with immunoglobulins or blood products within 28 days prior to screening;\n  * Administration of live attenuated vaccines within 28 days prior to screening or planned during the study period;\n  * Allergen-specific immunotherapy within 6 months prior to screening (allowed only if: initiated \\>3 months before screening, maintained at a stable dose for ≥1 month before Visit 1, and no planned dose changes during the study)；\n  * Participation in other drug\u002Fmedical device clinical trials within 3 months prior to screening (based on last administration\u002Fuse).\n  * Use nasal antihistamines (such as olopatadine nasal spray, azelastine nasal spray, levocabastine nasal spray, etc.) for the first 3 days.\n* Screening for a history of active pulmonary tuberculosis within the past 12 months；\n* Exclusion of infections within the last 14 days requiring systemic antibiotic, antiviral, antifungal, antiparasitic, or antiprotozoal therapy;\n* Exclusion of subjects diagnosed with helminthic parasitic infection in the past 6 months who either did not receive standard treatment or had treatment failure；\n* Known or suspected history of immunosuppression, immune dysfunction, or immune dysregulation, including but not limited to invasive opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved; Or there is an unusual frequency, recurrence, or prolonged infection (as judged by the investigator).\n* The forced expiratory volume in the first second (FEV1) of the subjects during the screening\u002Fintroduction period was ≤ 50% of the normal predicted value.\n* Patients with comorbid asthma who meet any of the following criteria:\n\nAsthma exacerbation within 90 days before screening, or current use of inhaled corticosteroids (ICS) at a daily dose higher than 1000μg fluticasone (or equivalent).\n\nDefinition of Asthma Acute Exacerbation:\n\n* Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline OCS) for at least 3 consecutive days due to worsening asthma; a single injection of depot long-acting corticosteroids may be considered equivalent to a 3-day course of systemic corticosteroids.\n* An emergency department or urgent care center visit due to asthma requiring systemic corticosteroids (as described above) (defined as evaluation and treatment in the emergency department or urgent care center lasting \\\u003C24 hours).\n* Hospitalization due to asthma (defined as admission to a medical facility and\u002For evaluation and treatment in a healthcare setting lasting ≥24 hours).\n\n  * Use of leukotriene antagonists\u002Fmodulators prior to randomization (subjects who have been on a stable dose of leukotriene modulators for ≥30 days continuously prior to randomization may be enrolled);\n  * Presence of other concurrent active or clinically significant respiratory diseases that, in the investigator's judgment, may significantly impact the study, such as active tuberculosis, lung cancer, bronchiectasis, pulmonary sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, or other active pulmonary conditions\n  * Subjects who have undergone lobectomy or lung volume reduction surgery within 12 months prior to the start of the study;\n  * Exclusion of subjects with cardiovascular conditions (including but not limited to unstable ischemic heart disease, heart failure, uncontrolled hypertension, myocardial infarction, significant arrhythmias, long QT syndrome, or Fridericia-corrected QT interval (QTcF) prolongation \\[≥450 ms in men, ≥470 ms in women\\]) if the investigator deems participation could compromise safety or study outcome interpretation;\n  * Exclude individuals with difficult venous access or a history of vasovagal syncope (needle\u002Fblood-related);\n  * Exclusion of any current active malignancy or history of malignancy (Patients with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are eligible if curative treatment was completed \\>12 months before V1. Patients with other malignancies are eligible if curative treatment was completed at least 5 years before V1).\n  * Presence of active autoimmune diseases (including but not limited to Hashimoto's thyroiditis with hyperthyroidism, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis and other neuroinflammatory disorders, psoriasis vulgaris, and rheumatoid arthritis);\n  * Exclusion if any infectious disease screening indicator meets the following criteria during screening;\n* Exclusion of subjects who are positive for hepatitis B virus surface antigen (HBsAg).\n* Hepatitis B virus core antibody (HBcAb) with detectable Hepatitis B Virus (HBV)-DNA.\n* Exclude if Hepatitis C Virus (HCV) antibody-positive and HCV-RNA positive, or if previously treated for HCV (regardless of current HCV-RNA status).\n* Anti-Treponema pallidum antibody (Anti-TP) positive (if syphilis serology is positive, a non-treponemal test must be performed; subjects with a negative non-treponemal test and deemed by the investigator as previously cured are eligible).\n* Anti-HIV positive\n\n  * Abnormal laboratory test results:\n* White blood cell count \\\u003C3.5 × 10⁹\u002FL;\n* Aspartate aminotransferase (AST) \\>2.5 × upper limit of normal (ULN);\n* Alanine aminotransferase (ALT) \\>2.5 × ULN;\n* Total bilirubin \\>2 × ULN;\n* Creatinine \\>1.5 × ULN\n\n  * Any clinically significant abnormal findings during the import period, including physical examination, vital signs, 12-lead ECG, blood biochemistry, hematology, or urinalysis, which in the investigator's judgment may place the patient at risk, affect study results, or impair the patient's ability to complete the entire study\n  * Women who are pregnant or lactating.\n  * Those who were still smokers or had quit smoking for less than six months at the time of screening.\n  * Exclude those with regular excessive alcohol consumption (\\>14 units\u002Fweek for females or \\>21 units\u002Fweek for males) in the past 6 months, inability to abstain during the trial, or a positive breath alcohol test.\n  * History of drug abuse within the past 2 years, or a positive drug abuse screening result.\n  * Subjects with a known history of hypersensitivity or allergic reaction to any ingredient of mometasone furoate nasal spray (Nasonex®) or TQC2731 injection.\n  * Exclusion for any history of systemic allergic reaction to biologic agents (local injection site reactions excluded).\n  * The participant demonstrated poor adherence and was deemed unable to complete the study.\n  * Any medical or psychiatric condition that, in the judgment of the investigator or the sponsor's medical reviewer, may affect the subject's safety throughout the study or impede the subject's ability to complete the entire study process or interfere with the interpretation of study results, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic disorders, psychiatric illnesses, or major physical disabilities.",{"count":183,"type":20},246,[23],"TQC2731 injection is a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP), blocks the TSLP pathway, and inhibits the production of downstream cytokines, thereby exerting anti-inflammatory effects. The purpose of this study is to evaluate the efficacy and safety of TQC2731 injection in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).",[187],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","2025-12-09",{"date":150,"type":31},{"date":191,"type":31},"2025-09-25",{"date":193,"type":20},"2027-09",{"name":37,"class":38},60,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100607392","phase-3-evaluation-of-the-efficacy-and-safety-of-tqb2825-injection-compared-to-immunotherapy-in-the-treatment-of-recurrentrefractory-follicular-lymphoma-100607392","NCT07187960","Evaluation of the Efficacy and Safety of TQB2825 Injection Compared to Immunotherapy in the Treatment of Recurrent\u002FRefractory Follicular Lymphoma","Randomized, Open Label, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2825 Injection Compared to Immunotherapy in the Treatment of Relapsed\u002FRefractory Follicular Lymphoma","Inclusion Criteria:\n\n1. Voluntarily join this study, sign the informed consent form (ICF), and have good compliance.\n2. 18 years old ≤ age\\\u003C80 years old (calculated based on the date of signing the informed consent form); No gender restrictions; Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-2.\n3. Expected survival is greater than 6 months.\n4. Follicular lymphoma (histological grade 1-3a) that meets the 2016 WHO diagnostic criteria or classic follicular lymphoma that meets the 2022 World Health Organization (WHO) diagnostic criteria, and immunophenotyping analysis shows CD20 positivity in the tumor.\n5. Relapsed\u002Frefractory diseases that have received at least 2 lines of systemic treatment (at least 1 line containing CD20 monoclonal antibody) in the past, and have progressed during the most recent treatment period or relapsed after completing treatment, or have been confirmed to have no objective remission after sufficient treatment.\n6. According to the 2014 Lugano criteria, there is at least one measurable lesion, which is a lymph node lesion with a length diameter greater than 15 mm or an extranodal lesion with a length diameter greater than 10 mm based on CT cross-sectional imaging.\n7. The organ function is good.\n8. Women of childbearing age should agree to use effective contraception during the study period and for 12 months after the end of study treatment, and agree not to donate eggs (oocytes) for reproductive purposes during this period; Not allowed to be in lactation period and have a negative serum or urine pregnancy test within 7 days before enrollment; Male patients who have not undergone vasectomy and their fertile female partners should agree to use effective contraceptive measures during the study period until 12 months after the end of the study treatment, and agree not to donate sperm during this period.\n\nExclusion Criteria:\n\n1. Have had or currently have other malignant tumors within the previous 5 years of randomization. The following two situations can be included in the group: other malignant tumors that have been cured by a single surgery and have achieved continuous disease-free survival (DFS) for 5 years; Cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\\].\n2. Lymphoma has previously or currently affected or is suspected to affect the central nervous system, or there is evidence of lymphoma leukemia present.\n3. There is evidence of transformation into diffuse large B-cell lymphoma or other types of lymphoma (such as biopsy showing large cells or Positron Emission Tomography (PET) showing significant abnormal high metabolism in one\u002Fsome lymph nodes).\n4. Active hepatitis or decompensated cirrhosis (Child Pugh liver function rating B or C). (Note: active hepatitis B refers to positive HBsAg, and Hepatitis B Virus (HBV) DNA is positive or the test value exceeds the upper limit of normal value; Active hepatitis C refers to Hepatitis B Virus (HCV) antibody positivity, and HCV RNA positivity or detection value exceeding the upper limit of normal; The eligible subjects with positive hepatitis B HBsAg but HBV DNA not exceeding the upper limit of normal value, whether their HBV DNA is measurable or not, need to continue antiviral treatment (nucleoside analogues are recommended) and regularly monitor HBV DNA; For subjects with positive hepatitis B HBcAb but negative HBsAg, HBV DNA needs to be monitored regularly, and preventive antiviral treatment is recommended; For subjects who are positive for hepatitis C HCV antibodies but whose HCV RNA does not exceed the upper limit of normal values, regular monitoring of HCV RNA is required.\n5. The adverse reactions of previous treatments have not recovered to CTCAE 5.0 standard ≤ grade 1, except for grade 2 hair loss, non clinically significant and asymptomatic abnormal laboratory test values, stable hypothyroidism treated with hormone replacement therapy, and other adverse reactions that have been determined by researchers to have no safety risks.\n6. Individuals who have undergone major surgical treatment, significant traumatic injury, or expected major surgery during the study treatment period within the first 4 weeks of randomization, or have long-term untreated wounds or fractures. (Note: Major surgery is defined as surgery at level 3 or above in the National Surgical Classification Catalogue 2022 edition)\n7. Within the first 4 weeks of randomization, any severe (≥ CTCAE grade 3) bleeding or bleeding events occurred.\n8. Uncontrolled pleural effusion and ascites with clinical significance that require repeated drainage, as well as moderate or greater amounts of pericardial effusion.\n9. Individuals who have experienced arterial\u002Fvenous thrombotic events within the first 6 months of randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis is not considered \"severe\" thromboembolism).\n10. Suffering from significant cardiovascular disease.\n11. Brain or mental abnormalities.\n12. lung disease.\n13. Active or uncontrolled infections.\n14. Unexplained fever\\>38.5 ℃ occurred during the screening period or before the first medication.\n15. Patients with renal failure who require hemodialysis or peritoneal dialysis and have a history of nephrotic syndrome.\n16. History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.\n17. Patients with hypothyroidism and type 1 diabetes who are suffering from autoimmune diseases that need systemic treatment or who have received stable alternative treatment can be selected.\n18. Preparing for or having previously received organ transplantation, or having a significant host transplant response, or having previously received allogeneic hematopoietic stem cell transplantation.\n19. Systemic immunosuppressive therapy is required, including but not limited to: using cyclosporine, tacrolimus, etc. within the first 4 weeks of randomization, receiving high-dose glucocorticoid therapy (prednisone\\>30 mg\u002Fday or equivalent dose of other glucocorticoids), or receiving any other immunosuppressive therapy; Those who receive inhaled or topical corticosteroid treatment, or those who maintain a stable dose of prednisone\\\u003C10 mg\u002Fday or equivalent doses of other corticosteroid systems for at least 4 weeks prior to the first administration, or those who receive steroid controlled lymphoma symptoms or prophylactic medication to prevent infusion reactions prior to the administration of the investigational drug, may be selected.\n20. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n21. Previous history of anti-tumor treatment.\n22. Known to be allergic to research drug excipient components.\n23. Participated in and used other anti-tumor clinical trial drugs within the first 4 weeks or 5 half lives of randomization.\n24. According to the researcher's perspective, other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study or interfere with the interpretation of the research results.\n25. It is estimated that the patient's compliance in participating in this clinical study is insufficient.",{"count":204,"type":20},228,[23],"Evaluation of the efficacy and safety of TQB2825 injection compared to immunotherapy in the treatment of recurrent\u002Frefractory follicular lymphoma.",[208],"Follicular Lymphoma","2025-09-17",{"date":211,"type":31},"2025-09-23",{"date":213,"type":20},"2025-11",{"date":215,"type":20},"2029-02",{"name":37,"class":38},28,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},"100601415","phase-1-phase-i-clinical-trial-of-tqb2825-subcutaneous-injection-in-cd20-positive-hematological-malignancies-100601415","NCT07110194","Phase I Clinical Trial of TQB2825 Subcutaneous Injection in CD20-positive Hematological Malignancies","Inclusion Criteria:\n\n* The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;\n* Age 18 years or older and less than 80 years (calculated based on the date of signing the informed consent form);\n* Eastern Cooperative Oncology Group (ECOG) score 0 to 2 points;\n* Expected survival greater than 12 weeks;\n* Malignant hematological tumors diagnosed by histological or cytological means, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma, etc.;\n* Immunophenotype analysis shows that the tumor is CD20 positive;\n* Previously received at least one adequate treatment with a CD20 monoclonal antibody regimen (combined chemotherapy or single drug), and the most recent adequate treatment did not lead to remission or disease progression after remission, or relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT);\n* According to the 2014 Lugano criteria, there is at least one measurable lesion, that is, based on Computed Tomography (CT) cross-sectional images, the long diameter of lymph node lesions is greater than 15 mm or the long diameter of extranodal lesions is greater than 10 mm; Positron Emission Tomography - Computed Tomography scan (PET-CT) scan shows positive PET;\n* Laboratory tests meet the following criteria (within 14 days before screening, no blood transfusion, no use of hematopoietic stimulating factors and other drugs to correct):\n\n  1. Hemoglobin (HGB) ≥ 80 g\u002FL;\n  2. Absolute neutrophil count (NEUT) ≥ 1.0 × 109\u002FL;\n  3. Platelet count (PLT) ≥ 75 × 109\u002FL (if accompanied by bone marrow invasion, platelet ≥ 50 × 109\u002FL).\n  4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);\n  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If accompanied by liver metastasis, then ALT and AST ≤ 5 ULN;\n  6. Serum creatinine (CR) ≤ 1.5 ULN or estimated glomerular filtration rate by Cockcroft-Gault formula ≥ 50 ml\u002Fmin.\n  7. Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5 × ULN (not receiving anticoagulant treatment);\n* Pregnant women should agree to use effective contraceptive measures during the study period and within 12 months after the study ends. For men, they should agree to use effective contraceptive measures during the study period and within 12 months after the study ends.\n\nExclusion Criteria:\n\n* Within the 5 years prior to the first medication administration, the subject had or currently has other malignant tumors. The following two situations can be included in the study: other malignant tumors treated by a single surgical procedure, achieving 5 consecutive years of disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumors), Tis (in situ cancer), and T1 (tumor infiltration of the basement membrane)\\];\n* Previous treatment-induced adverse reactions have not recovered to a Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5.0) score of ≤1, except for grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, stable thyroid function hypofunction after hormone replacement therapy, etc., which are judged by the investigator to have no safety risks;\n* Previous anti-tumor treatment:\n\n  1. Within 4 weeks before the first administration, received chemotherapy, immunotherapy, monoclonal antibody treatment, radiation therapy within 2 weeks, or small molecule targeted drugs, or still within the 5 half-lives of the drug (based on the earliest occurrence time), calculate the washout period from the end of the last treatment;\n  2. Treatment with Chinese patent medicines (including Compound Banmao Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Yadanzi Oil Injection\u002FCapsules, Xiaoaiping Tablets\u002FInjection, Huachansu Capsules, etc.) that are explicitly approved by the National Medical Products Administration (NMPA) with anti-tumor indications in the package insert within 2 weeks prior to the first dose;\n  3. Previously used other antibodies targeting both CD3 and CD20 for treatment;\n  4. Received Chimeric Antigen Receptor T-cell (CAR-T) treatment, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first administration;\n* Lymphoma has previously or currently involved or is suspected to involve the central nervous system or lymphoma leukemia;\n* Within 4 weeks before the first administration, received major surgical treatment, significant traumatic injury, or expected to undergo major surgery during the study treatment, or has long-standing unhealed wounds or fractures;\n* Within 4 weeks before the first administration, experienced any bleeding or bleeding event ≥ Common Terminology Criteria for Adverse Events (CTC AE) 3 grade in the subject.\n* Within 6 months before the first administration, had a thromboembolic event such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism, or any history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis is not considered \"serious\" thromboembolism);\n* Has clinically significant uncontrolled need for repeated drainage of pleural effusion, ascites, or moderate or above pericardial effusion; Decompensated liver cirrhosis (Child-Pugh liver function rating of B or C) and active hepatitis (B).\n* Pulmonary diseases, including any of the following conditions:",{"count":225,"type":20},75,[95],"The aim of this study is to evaluate the pharmacokinetic characteristics, safety and efficacy of the TQB2825 injection (subcutaneous administration) in patients with CD20-positive hematological malignancies.",[229],"CD20-positive Hematological Malignancies","2025-07-31",{"date":232,"type":31},"2025-08-07",{"date":234,"type":20},"2025-09",{"date":236,"type":20},"2027-12",{"name":37,"class":38},1,{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100581756","phase-2-clinical-trial-of-tqb2825-injection-combined-with-chemotherapy-in-subjects-with-diffuse-large-b-cell-lymphoma-100581756","NCT06854445","Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma","Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* The subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;\n* Age ≥18 years (calculated from the date of informed consent);\n* Eastern Cooperative Oncology Group (ECOG) score 0 \\~ 2 points;\n* Expected survival greater than 12 weeks;\n* Histological or cytological diagnosis of diffuse large B-cell lymphoma in accordance with the World Health Organization (WHO) diagnostic criteria in 2022;\n* Pathological diagnosis results containing CD20 positive expression and Myc rearrangement negative after anti-CD20 treatment must be provided;\n* Subjects with relapsed or refractory diffuse large B-cell lymphoma who have received at least 1 line of systemic therapy;\n* Not suitable for hematopoietic stem cell transplantation;\n* According to the Lugano criteria in 2014, there is at least one measurable lesion, that is, the long diameter of lymph node lesions \\> 15 mm or extranodal lesions \\> 10 mm according to CT cross-sectional images; Positron emission tomography - computerized tomography (PET-CT) scan shows PET positive;\n* Laboratory tests meet specific criteria;\n* Adopt effective contraceptive measures;\n\nExclusion Criteria:\n\n* Subjects who had or currently had other malignant tumors within 5 years prior to the first dose;\n* Previous or current involvement or suspected involvement of the central nervous system by lymphoma;\n* Failure to recover from adverse reactions to Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0) criteria ≤ grade 1 from previous treatment;\n* History of previous anti-tumor treatment:\n\n  1. previous use of other antibody drugs targeting CD3 and CD20 at the same time;\n  2. received Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first dose;\n  3. previous treatment with R-GemOx or GemOx;\n  4. received chemotherapy, immunotherapy, monoclonal antibody therapy 4 times before the first dose, 2 times received radiotherapy or small molecule targeted drugs, or subjects who are still within 5 half-lives of the drug, the washout period is calculated from the end time of treatment;\n  5. received treatment with Chinese patent medicines with clear anti-tumor indications in the package insert of National Medical Products Administration (NMPA)-approved drugs 2 times before the first dose;\n* Subjects who have undergone major surgical treatment, significant traumatic injury, or expected major surgery during the study treatment period within 4 weeks prior to the first use of medication, or have long-term untreated wounds or fractures;\n* Subjects who experience any bleeding or bleeding events ≥ Common Terminology Criteria Adverse Event (CTC AE) grade 3 within 4 weeks prior to the first administration;\n* Hyperactive\u002Fvenous thrombotic events within 6 months prior to first dose,Such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism or any other history of severe thromboembolism;\n* Clinically significant uncontrolled pleural effusion, ascites and more than moderate pericardial effusion requiring repeated drainage;\n* Decompensated cirrhosis (Child-Pugh class B or C liver function) and active hepatitis;\n* Pulmonary disease, including any of the following: 1) with or without current pneumonitis requiring corticosteroid therapy; 2) with or suspected chronic obstructive pulmonary disease (COPD), and forced expiratory volume in 1 second (FEV1) \\\u003C 60% (predicted);\n* Brain or mental disorders;\n* Have major cardiovascular disease;\n* Active or uncontrolled infection (≥ CTCAE grade 2 infection), including bacterial, fungal or viral infections including but not limited to active pneumonia, syphilis and tuberculosis.\n* Unexplained fever \\> 38.5℃ during screening or before the first dose;\n* Renal failure requiring hemodialysis or peritoneal dialysis, previous history of nephrotic syndrome;\n* History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases;\n* Have or have had prior autoimmune disease requiring treatment.\n* Prepare to undergo or have previously received organ transplantation, or have a significant host transplant response, or have previously received allogeneic hematopoietic stem cell transplantation; 19、Need to receive systemic immunosuppressive therapy;\n* Known or suspected history of hemophagocytic syndrome (HLH);\n* Known hypersensitivity to excipient components of the study drug.\n* Subjects who participated in other anti-tumor clinical trials within 4 or 5 half-lives before the first dose.\n* Any condition that, in the judgment of the investigator, would jeopardize the safety of the subject or prevent the subject from completing the study.",{"count":247,"type":20},55,[96],"The purpose of this study is to assess the preliminary efficacy of TQB2825 in combination with chemotherapy in subjects with diffuse large B-cell lymphoma.",[251],"Diffuse Large Cell B-lymphoma","2025-03-19",{"date":254,"type":31},"2025-03-24",{"date":256,"type":31},"2025-03-12",{"date":258,"type":20},"2028-02",{"name":37,"class":38},24,""]