[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,47,57,95,126,151,176,205,227,253,279,301,319],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":4,"leadSponsor":43,"locationsCount":46},"100053333","natural-history-of-bronchiectasis-100053333",false,"NCT00943514","Natural History of Bronchiectasis","* PARTICIPANT INCLUSION CRITERIA:\n\n  1. Children age 5 years and above and adults referred to the NIH with chronic or recurring respiratory infections will be eligible for participation.\n  2. Males and females will be considered without regard to race or ethnicity or upper age limit.\n  3. Emphasis will be primarily on non CF bronchiectasis for elucidation of mechanisms of infection susceptibility. However, select patients with cystic fibrosis or acquired immune defects (such as HIV) may be studied if relevant host defects are suspected, if needed for comparison purposes, or to evaluate and study the management of chronic pathogen associated conditions such as nontuberculous mycobacterial infections or allergic bronchopulmonary aspergillosis.\n  4. Subjects must have a primary or referring physician\n  5. Subjects must be willing to have samples stored\n\nINCLUSION CRITERIA FOR RELATIVES:\n\nAs a part of this protocol we may obtain blood, sputum, urine, or buccal swabs from some blood relatives of patients on the study, with the hope of isolating and characterizing the primary host defense defect(s) or genetic links responsible for airway infection susceptibility and\u002For bronchiectasis seen within families. Male and female relatives will be accepted without limitation due to age. These relatives may have pertinent disease-related history obtained, but will neither receive treatment nor have any other protocol procedures done unless they are enrolled on the study.\n\nPARTICIPANT EXCLUSION CRITERIA:\n\n1. We wish to avoid enrolling subjects, especially children, who have common respiratory problems (aeroallergen sensitivity, asthma, gastric esophageal reflux) that are not associated with an underlying abnormality in host defenses. Evidence of significance of chronic or recurring infections suggestive of an underlying airway surface or systemic host defense defect should be documented by one or more of the following: a) sinus or lower airway cultures positive for bacterial, fungal, or mycobacterial pathogens characteristic of these defects; or b) radiographic evidence of sinusitis with mucosal thickening and\u002For air-fluid levels; or c) radiographic evidence of bronchiectasis; d) severity of otitis media requiring placement of tympanic membrane pressure equalization tubes; e) severity of sinusitis requiring surgical intervention.\n2. Patients who are unable or unwilling to provide informed consent either directly or via appropriately designated surrogate.\n3. Any patient who, in the opinion of the Investigator, is unable or unwilling to comply with regular follow-up or is unlikely to provide pertinent information regarding disease progression or response to treatment may be excluded from longitudinal follow-up.\n\nPARTICIPATION OF CHILDREN:\n\nChildren under the age of 5 will be excluded from this protocol due to the difficulty of performing pertinent assays in infants and younger children, difficulty distinguishing significance of respiratory infections which occur commonly in younger children, and the lack of adequate facilities and equipment for management of children younger than 2 years.",true,"ALL","5 Years","100 Years",{"count":20,"type":21},900,"ESTIMATED","OBSERVATIONAL","Background:\n\n* Bronchiectasis is a disease characterized by airways that are inflamed, abnormally dilated, and chronically infected. Individuals with bronchiectasis have a history of chronic and recurring respiratory infections. Depending on the underlying cause, these infections may involve the entire respiratory tract, resulting in sinus, ear, and lung disease.\n* Bronchiectasis continues to be a significant problem in developing countries and in specific groups of individuals, particularly in people who have cystic fibrosis. Although treatments are available or under development for bronchiectasis related to cystic fibrosis, many of the disease-specific treatments may not be effective for bronchiectasis not related to cystic fibrosis.\n\nObjectives:\n\n\\- To study the natural history of bronchiectasis to identify inherited and immune factors that may explain why certain individuals have chronic recurring infections.\n\nEligibility:\n\n* Individuals 5 years of age and older who have an established diagnosis of bronchiectasis or a history of chronic\u002Frecurring respiratory infections.\n* Direct family members (e.g., parents, siblings, children) of patients in the study may also be asked to participate.\n\nDesign:\n\n* Potential participants will be screened with an initial clinic evaluation and full medical history, as well as a general quality of life and respiratory symptom questionnaire.\n* The following standard procedures may be done as part of the study: air sampling from the nose; imaging studies, which may include an x-ray or computed tomography (CT), lung function tests; and collection of samples of blood, urine, and sputum (phlegm or mucus). Other tests may be performed as required by the researchers, and will be explained to patients as needed.\n* Both patients and relatives (if asked to participate) will provide the following samples: blood or buccal (cheek swab) cells for genetic testing, sputum, and urine.\n* To prevent infections and potential disease progression, patients may receive standard medical care and treatment for bronchiectasis and related infections during this protocol.",[25,26,27,28],"Bronchiectasis","Cystic Fibrosis","Autoimmune Disease","Common Variable Immunodeficiency",[30,31,32,33,34,35],"Variant Cystic Fibrosis","Bronchopulmonary Mycosis","Airway Infection Susceptibility","Chronic Respiratory Infection","Primary Ciliary Dyskinesia","Natural History","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2009-08-01",{"name":44,"class":45},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":48,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":50,"keywords":51,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":4,"leadSponsor":56,"locationsCount":46},"100128676",{"count":20,"type":21},[25,26,27,28],[30,31,32,33,34,35],"2026-06-18",{"date":54,"type":40},"2026-06-22",{"date":42,"type":40},{"name":44,"class":45},{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)","18 Years",{"count":66,"type":21},300,"INTERVENTIONAL",[69],"PHASE1","This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[27,72,73,74,75,76,77,78,79,80,81,82,83,84],"Crohn Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Psoriatic Arthritis","Rheumatoid Arthritis","Sjogren Syndrome","Systemic Lupus Erythematosus","Systemic Scleroderma","Ulcerative Colitis","2026-06-16",{"date":87,"type":40},"2026-06-17",{"date":89,"type":40},"2019-07-16",{"date":91,"type":21},"2028-03-30",{"name":93,"class":45},"National Cancer Institute (NCI)",52,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":67,"phases":104,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100131289","phase-2-rituximab-plus-cyclosporine-in-idiopathic-membranous-nephropathy-100131289","NCT00977977","Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Male or female, \\>= 18 years of age\n3. Nephrotic range proteinuria that persists for at least 6 months post diagnosis of membranous nephropathy greater than 3.5 grams \u002F24 hours (based on 24-hour urine collection).\n\n   a. If the subject s renal function rapidly declines in less than 6 months could proceed with immunosuppression therapy sooner such as complications of the nephrotic syndrome that are not controlled with supportive therapy or evidence of decline in glomerular filtration rate or proteinuria \\>8 grams\u002Fday. Subjects with declining renal function and\u002For high-grade proteinuria due to MN are considered \"high risk\" subjects and have a higher probability of progression to end stage kidney disease.\n4. Nephrotic range proteinuria (\\>3.5 g\u002F24 hours) that persists despite angiotensin antagonist therapy (ACE inhibitor or ARB) for at least 2 months unless intolerant.\n\n   a. The rationale is that blockade of the renin angiotensin system (RAAS) is widely considered to be part of the standard of care treatment for subjects with the nephrotic syndrome. Nephrotic range proteinuria will be defined as an estimated average proteinuria \\>3.5 g\u002F24 hours in adults based on at least two 24-hour urine protein excretions obtained prior to initiating therapy. Incomplete urine\n\n   collections (based on inadequate creatinine excretion) will be excluded.\n5. Renal biopsy within the past 24 months must reveal typical changes of membranous nephropathy by light and electron microscopy or a positive anti-PLA2R antibody test in the serum. There has been a change in the management strategies for MN such that a renal biopsy is not absolutely required for diagnosis if patient has positive circulating anti-PLA2R antibody.\n\n   a. Based on published KDIGO 2021 Clinical Practice Guidelines 3.1.1 patients with MN who are positive for anti-PLA2R do not require renal biopsy as long as renal function is normal (eGFR \\>60) and has not had immunosuppression as it has been demonstrated that results of the biopsy have not altered clinical approach and management. If not PLA2R positive, renal biopsy within 24 months is still required.\n6. Blood pressure \\\u003C=140\u002F90 on \\>75% of measurement while on anti-hypertensive treatment for at least 1-2 months.\n7. There is no evidence to suggest secondary forms of membranous nephropathy.\n8. Ability to take oral medication and be willing to adhere to the cyclosporine regimen\n9. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for 12 months after the last Rituximab infusion.\n10. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.\n11. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Estimated GFR\\\u003C40 ml\u002Fmin\u002F1.73 m\\^2 from the preceding 2 months prior to enrollment while on ACEI\u002FARB therapy.\n2. Immunosuppressive medications or experimental medications of any type during the three-month period prior to initiating Rituximab and cyclosporine.\n3. Prior exposure to cyclosporine or tacrolimus for more than 6 months and\u002For evidence of intolerance or toxicity associated with cyclosporine treatment of any duration including irreversible azotemia, liver dysfunction or hypertension\n4. Rituximab use within the previous 12 months.\n5. Clinically significant medical conditions (i.e., severe heart failure NYHA class IV, uncontrolled coronary artery disease\u002Funstable angina), which in the opinion of the investigator, could increase the subject s risk of participating in the study or could confound the interpretation of the results of the study.\n6. Positive HIV serology\n7. Positive HCV serology\n8. Active acute or chronic infection requiring antimicrobial therapy or serious viral infection cytomegalovirus, herpes simplex, varicella zoster virus (chicken pox or shingles), Parvovirus B19 (can be based on previous medical records within the past 24-months)\n9. Live viral vaccines within one month prior to Rituximab.\n10. Pregnancy or lactation\n11. Cancer diagnosis or cancer recurrence within the preceding 5 years, excluding basal cell carcinoma of the skin. The rationale is that immunosuppression may accelerate cancer progression.\n12. Clinical evidence of cirrhosis or chronic active liver disease sufficiently severe to impair cyclosporine metabolism; this would include a prolonged prothrombin time.\n13. Cytopenia (neutrophils \\\u003C1500\u002Fmm\\^3 and\u002For thrombocytopenia \\\u003C75,000) and\u002For CD4 T cell count \\\u003C200\u002Fmm\\^3). The rationale is that Rituximab therapy may be followed by cytopenia with the granulocyte lineage being at greatest risk. Patients with low CD4 T cell counts are prone to infection which can be exacerbated by Rituximab.\n14. Diabetes mellitus. The rationale is that diabetes may lead to worsening of proteinuria that would not respond to immunosuppression and would confound the results.","90 Years",{"count":103,"type":21},30,[105],"PHASE2","Background:\n\n* Membranous nephropathy is associated with damage to the walls of the glomeruli, the small blood vessels in the kidneys that filter waste products from the blood. This damage causes leakage of blood proteins into the urine and is associated with low blood protein levels, high blood cholesterol values, and swelling of the legs. These problems can decrease or go away without treatment in about 25 percent of patients, but if they persist, some patients may experience impaired (or loss of) kidney function, blood vessel and heart disease, and a risk of forming blood clots in veins.\n* Kidney biopsies that show that antibodies have been deposited along the glomeruli suggest that specialized cells of the immune system, called B and T cells, are causing damage to the kidneys through their increased activity. To suppress the action of B and T cells and to decrease the harmful deposits in the kidneys, drug treatments are required.\n* Patients with membranous nephropathy are often treated with immunosuppressive drugs such as cyclosporine or cytoxan plus steroids that attempt to reduce or suppress the activity of the immune system, decrease antibody production, and reduce antibody deposits in the kidney. However, not everyone responds to these medications and the kidney disease can return in some patients when the drugs are stopped. Also, there are side effects associated with long term usage of these medications. Rituximab, a different immunosuppressant, has also been used for this purpose. Although cyclosporine and Rituximab have been used separately, they have not been tried in combination as a possible treatment for membranous nephropathy.\n\nObjectives:\n\n\\- To determine the safety and effectiveness of combining rituximab and cyclosporine to treat membranous nephropathy.\n\nEligibility:\n\n\\- Individuals 18 years of age and older who have been diagnosed with membranous nephropathy based on a kidney biopsy done within the preceding 24 months, and who have had excess levels of protein in the urine for at least 6 months based on urine and blood tests.\n\nDesign:\n\n* Potential participants will be screened with an initial clinic evaluation and full medical history.\n* Before the treatment, there will be a run-in period that will last up to 2 months. During this time, participants will be placed on a blood pressure lowering medication and will not take any other immunosuppressant medications.\n* Participants will visit the NIH clinical center for a baseline evaluation, four intravenous infusions of rituximab, and also at 1- to 6-month intervals throughout the study.\n* Active treatment period will involve a 6-month course of cyclosporine and a total of four doses of rituximab. Participants will take cyclosporine tablets twice daily, and have two infusions of rituximab given 2 weeks apart, After 6 months, the cyclosporine dose will slowly be decreased over several weeks and then completely discontinued. Participants will then receive another course (two doses 2 weeks apart) of rituximab, depending on results of blood work.\n* Participants will have frequent blood and urine tests performed to monitor the results of treatment and reduce the chance of side effects.",[108,109,27,110,111],"Nephrotic Syndrome","Proteinuria","Glomerular Disease","Membranous Glomerulonephritis",[113,108,114,115,109],"Kidney Disease","Autoimmune Diseases","Clinical Trial","2026-06-11",{"date":118,"type":40},"2026-06-12",{"date":120,"type":40},"2010-12-22",{"date":122,"type":21},"2027-12-31",{"name":124,"class":45},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":67,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":150},"100578945","phase-2-remdesivir-for-the-treatment-of-upper-respiratory-tract-infection-due-to-rsv-in-immunocompromised-individuals-100578945","NCT06817889","Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals","An Open-Label Study to Assess the Safety and Efficacy of Remdesivir for Treatment of Symptomatic Laboratory-Confirmed Respiratory Syncytial Virus Infection of the Upper Respiratory Tract in Patients Receiving Cellular or Bispecific Antibody Therapies","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)\n* RSV confirmed by local lab testing via nucleic acid amplification test (e.g. polymerase chain reaction \\[PCR\\] or respiratory viral panel \\[RVP\\]) using an upper respiratory tract sample collected within the 5 days prior to day 1 (RDV dosing)\n* Symptomatic RSV infection of the upper respiratory tract, with symptom onset and positive microbiologic testing within the 5 days prior to day 1 (RDV dosing). Symptomatic RSV infection is defined as having new upper respiratory symptom(s) or worsening of a pre-existing upper respiratory symptom (if chronic and associated with a previously existing diagnosis, such as chronic lung disease, chronic rhinorrhea, or seasonal allergies)\n* Receiving treatment for a refractory or relapsed hematologic malignancy, or received a hematopoietic cell transplant (HCT), chimeric antigen receptor T cell therapy (CARTx), or bispecific antibody (bsAb) therapy within the past 365 days (relative to RSV diagnosis date)\n* Categorized as moderate-risk (overall score 3-6) or high-risk (overall score 7-10) per an adapted version of the Immunodeficiency Scoring Index (ISI) for RSV, as below, relative to the day of RSV diagnosis:\n\n  * 1 point:\n\n    * Recent (within the prior 30 days) allogeneic HCT, autologous HCT, or CARTx\n    * Corticosteroids within the prior 30 days for management of graft versus host disease (GVHD) or cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).\n  * 2 points:\n\n    * Age ≥ 40 years\n  * 3 points:\n\n    * Absolute neutrophil count (ANC) \\\u003C 500 cells\u002FμL within the prior 7 days\n    * Absolute lymphocyte count (ALC) \\\u003C 200 cells\u002FµL within the prior 7 days\n* Oxygen saturation (SpO2) 93% or greater on room air and at rest (to be measured after participant has rested in a quiet room for ≥ 2 minutes, with oxygen \\[O2\\] saturation probe on finger or earlobe for ≥ 1 minute, with saturation reading remaining ≥ 93%) at screening\n* Willingness to take study drug and complete necessary study procedures\n* Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described\n\nExclusion Criteria:\n\n* Received or receiving an approved or authorized direct-acting antiviral therapy with potential efficacy against RSV (e.g. ribavirin) for ≥ 24 hours within the prior 7 days, and\u002For expected to receive anti-RSV direct-acting antiviral therapies for RSV during the course of the study at the time of screening\n* Received or receiving investigational direct-acting antiviral therapies against RSV for the current RSV episode\n* Received any investigational anti-RSV monoclonal antibodies or off-label use of approved anti-RSV monoclonal antibodies within \\\u003C 4 months or \\\u003C 5 half-lives, whichever is longer, before screening, or expected to receive anti-RSV monoclonal antibodies during the course of the study at the time of screening\n* Received an RSV vaccine after cellular therapy or after starting the current antitumor therapeutic regimen\n* Participation in any other concurrent clinical trial of an experimental treatment for RSV, including RSV vaccines\n* Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal within 7 days prior to screening\n* Unable to tolerate nasal sampling required for this study, as determined by the investigator (e.g., history of significant epistaxis, nasopharyngeal anatomical abnormalities, nasal or sinus surgery)\n* A life expectancy of three months or less, as determined by the investigator\n* Pregnant, as determined by a Point-of-Care urine pregnancy test or reported by the patient or their electronic health record within 7 days of screening\n* Receiving, requiring, or expected to require supplemental oxygen for RSV-related illness or SpO2 \\\u003C 93% at rest \\\u003C 24 hours prior to study drug administration\n* Previous infection or treatment for RSV, or previous treatment or hospitalization for another respiratory viral infection, \\\u003C 28 days before screening\n* Documented positive test for other respiratory viruses concomitantly (limited to influenza, parainfluenza, adenovirus, human metapneumovirus, or coronavirus \\[including SARS-CoV-2\\]) ≤ 7 days prior to screening, as determined by local testing (additional testing not required)\n* Clinically significant bacteremia or fungemia ≤ 7 days prior to screening and not adequately treated, as determined by the investigator\n* Clinically significant bacterial, fungal, or viral pneumonia within two (2) weeks prior to screening and not adequately treated, as determined by the investigator\n* Clinically significant symptoms of CRS or ICANS within the prior 72 hours before screening that is not adequately controlled, as determined by the investigator\n* Any inability to take study drug or comply with study procedures that, in the opinion of the investigator, would make the participant unsuitable for the study\n* Known hypersensitivity or allergy to the study drug, its metabolites, or formulation excipients",{"count":134,"type":21},60,[105],"This phase II trial tests how well remdesivir works for treatment of respiratory syncytial virus (RSV) infection of the upper respiratory tract in patients receiving cellular or bispecific antibody therapy. Cellular or bispecific antibody therapies cause suppression of the immune system, making infections more frequent and reducing the body's ability to fight the infections. RSV infections are one of the most common respiratory infections in immunocompromised individuals and can cause significant pneumonia and even death. Remdesivir is in a class of medications called antivirals. It works by stopping viruses from spreading in the body.",[138,27,139],"Hematopoietic and Lymphatic System Neoplasm","Respiratory Syncytial Virus Infection","2026-06-01",{"date":142,"type":40},"2026-06-03",{"date":144,"type":40},"2025-12-23",{"date":146,"type":21},"2027-11-30",{"name":148,"class":149},"Fred Hutchinson Cancer Center","OTHER",3,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":46},"100420181","testing-of-an-educational-tool-for-patients-with-melanoma-and-pre-existing-autoimmune-disease-who-are-candidates-for-immune-checkpoint-inhibitors-100420181","NCT04751396","Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors","Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers","Inclusion Criteria:\n\n* Diagnosis of melanoma\n* Diagnosis of pre-existing autoimmune disease\n\n  * Inflammatory bowel disease\n\n    * Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist\n    * For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically\n    * Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists)\n  * Rheumatoid arthritis\n\n    * Diagnosis of rheumatoid arthritis by a rheumatologist\n    * Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy\n  * Systemic lupus erythematosus\n\n    * Diagnosis of systemic lupus erythematosus by a rheumatologist\n  * Psoriasis\n\n    * Diagnosis of psoriasis by a dermatologist\n    * Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies\n  * Spondyloarthropathies\n\n    * Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis\u002Fspondylitis by a rheumatologist\n    * Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy\n* Age of 18 years or older\n* Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor\n* E-mail access and computer with Internet access or telephone\n* Ability to communicate in English or Spanish\n* CLINICIAN\n* Prescribed immune checkpoint inhibitors\n* Are providing care for patients with melanoma\n* In the clinics at MD Anderson",{"count":159,"type":21},125,"This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.",[162,27,72,163,164,75,165,78,79,166,80,82,84],"Ankylosing Spondylitis","Enteropathic Arthritis","Enteropathic Spondylitis","Melanoma","Reactive Arthritis","2026-05-18",{"date":169,"type":40},"2026-05-20",{"date":171,"type":40},"2022-04-20",{"date":173,"type":21},"2027-02-02",{"name":175,"class":149},"M.D. Anderson Cancer Center",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":67,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":46},"100633176","phase-1-safety-and-preliminary-efficacy-of-hn2302-in-patients-with-autoimmune-diseases-100633176","NCT07523282","Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","AID","Inclusion Criteria:\n\n* Adults aged 18 to 69 years, regardless of gender.\n* Adequate bone marrow, coagulation, cardiopulmonary, hepatic, and renal function.\n* Participants who are not pregnant or breastfeeding and who agree to use effective contraception for 12 months after drug infusion, if applicable.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria, with a history of SLE for at least 6 months; during screening, participants must have positive antinuclear antibody (ANA), and\u002For positive anti-double-stranded DNA antibody, and\u002For hypocomplementemia.\n* Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR\u002FEULAR classification criteria, including limited cutaneous or diffuse cutaneous systemic sclerosis, with new or progressive skin manifestations within 6 months before screening.\n\nExclusion Criteria:\n\n* Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA; positive hepatitis C antibody with detectable or quantifiable HCV RNA; positive HIV antibody; positive CMV DNA; or positive syphilis antigen or antibody.\n* Presence of any other uncontrolled active infection.\n* History of major solid organ transplantation (for example, heart, lung, liver, or kidney transplantation) or bone marrow\u002Fhematopoietic stem cell transplantation.\n* Pregnant or breastfeeding women.\n* Receipt of any mRNA-LNP product or other LNP-based drug within the past 2 years.\n* History, within 6 months before screening, of any of the following cardiovascular conditions: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac disease.\n* Receipt of a live vaccine within 30 days before screening.\n* History of asthma or severe allergy, if considered clinically significant by the investigator.\n* Any condition that, in the investigator's opinion, would increase risk to the participant or interfere with study assessments.","69 Years",{"count":186,"type":21},12,[69],"This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).",[27,82,190],"Systemic Sclerosis (SSc)",[192,193],"SLE","SSc","NOT_YET_RECRUITING","2026-04-09",{"date":197,"type":40},"2026-04-14",{"date":199,"type":21},"2026-04-28",{"date":201,"type":21},"2028-06-30",{"name":203,"class":204},"Shenzhen MagicRNA Biotechnology Co., Ltd","INDUSTRY",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":15,"sex":16,"minAge":64,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":67,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":46},"100621149","phase-1-a-study-of-safety-tolerability-pk-and-pd-of-subcutaneous-gensci136-in-healthy-adults-100621149","NCT07366866","A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.","A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci136 for Injection in Healthy Adult Participants in China.","Inclusion Criteria:\n\n1. Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).\n2. Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg\u002Fm2 (both inclusive) at screening.\n3. Males of reproductive age and females of childbearing potential must agree to take highly effective contraceptive methods from screening to the end of the study, and have no plans for conception, sperm donation, or egg donation; females of childbearing potential must have a negative pregnancy test at screening\u002Fbaseline period and are not breastfeeding.\n4. Able to understand the trial procedures, voluntarily participate in the trial, understand and voluntarily sign the ICF, be able to follow all the trial requirements and complete the study.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug, compound, food, or other substance, or an allergic constitution.\n2. Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.\n3. A history or presence of other significant metabolic, dermatologic, hepatic, renal, hematologic, cardiovascular, gastrointestinal, psychoneurological, respiratory, and\u002For other major disease that, in the opinion of the investigator, would affect the evaluation of the study.\n4. Any major surgery within 3 months before screening, plan to undergo elective surgery during the study period, or have a history of any surgery that may affect the absorption, distribution, metabolism or excretion of the IMP.\n5. Positive result of alcohol breath test, or drug abuser, or use of soft drugs (such as marijuana) within 3 months prior to screening, or use of hard drugs (such as cocaine and ketamine) within 1 year prior to screening, or positive for drug screening \\[including but not limited to morphine, ketamine, dimethyldioxyamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine\\].\n6. Participants judged by the investigator to be ineligible for other reasons.","45 Years",{"count":214,"type":21},48,[69],"This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.",[27],"2026-03-22",{"date":220,"type":40},"2026-03-25",{"date":222,"type":40},"2026-03-16",{"date":224,"type":21},"2027-03-09",{"name":226,"class":204},"Changchun GeneScience Pharmaceutical Co., Ltd.",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":15,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":46},"100154331","the-1200-patients-project-studying-the-implementation-of-clinical-pharmacogenomic-testing-100154331","NCT01280825","The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing","Inclusion Criteria:\n\n* Receiving ongoing, out-patient care at the University of Chicago Medical Center under the routine care of a physician participating in this trial\n* Life expectancy of at least 3 years\n* Must be 18 years or older\n* Must be taking at least 1 (but not more than 6) prescription medications at the time of enrollment OR be 65 years or older OR be reasonably expected to require the use of a prescription medication within the next 5 years\n* Patients with certain diseases, or likely to receive or be receiving certain drugs, will be targeted particularly for enrollment in order to enrich the study for patients likely to have pharmacogenetically relevant interactions, including, but not limited to:\n\n  * Patients requiring specialized cardiology care\n  * Patients with inflammatory bowel diseases\n  * Patients with systemic autoimmune or inflammatory diseases\n  * Patients requiring long-term oral anticoagulation\n  * Patients with hepatitis C\n  * Patients with non-metastatic cancer\n\nExclusion Criteria:\n\n* Patients with acute or chronic disease which could be reasonably expected to result in the patient's death within the next 3 years.\n* Patients who have undergone, or are being actively considered for, liver or kidney transplantation.\n* Inability to understand and give informed consent to participate.",{"count":234,"type":21},1200,"The purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. The results will be made available to the patient's treating physician and the researchers will track whether or not this information is used in routine health care.",[237,238,239,27,240,241,242,243],"Patients Undergoing Routine Health Care","Heart Diseases","Inflammatory Bowel Diseases","Inflammatory Disease","Blood Coagulation Disorders","Hepatitis C","Non-Metastatic Neoplasm","2026-03-02",{"date":246,"type":40},"2026-03-04",{"date":248,"type":40},"2011-01-14",{"date":250,"type":21},"2027-12-14",{"name":252,"class":149},"University of Chicago",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":15,"sex":16,"minAge":260,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":263,"conditions":264,"keywords":268,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":125},"100516425","autoimmune-and-autoinflammatory-genetics-study-100516425","NCT06004349","Autoimmune and Autoinflammatory Genetics Study","Natural History and Genetics of VEXAS Syndrome and Related Autoinflammatory Syndromes","Inclusion Criteria:\n\nIn order to be eligible to participate in this study as a subject with known or suspected autoinflammatory disease, an individual must meet all of the following criteria:\n\n* Stated willingness to participate in study procedures (which at the very least includes providing a mail-in blood or saliva sample for genetic analysis);\n* Regardless of sex assigned at birth, at least one month of age;\n* A medical history that, in the expert opinion of the PI and study team, is consistent with the possibility of autoinflammatory disease or known diagnosis of an autoinflammatory disease, such as VEXAS syndrome; and\n* Ability of the subject, parents (in the case of children), or Legally Authorized Representative to understand and the willingness to sign a written informed consent document.\n\nIn order to be eligible to participate in this study as a family member of a subject with known or suspected autoinflammatory disease, an individual must meet all of the following criteria:\n\n* Stated willingness to participate in study procedures (which at the very least includes providing a mail-in sample for genetic analysis);\n* Regardless of sex assigned at birth, at least one month of age;\n* Relationship, either by blood or marriage, to an individual enrolled or about to be enrolled in the study with known or suspected autoinflammatory disease;\n* Likelihood, in the expert opinion of the PI and study team, that analysis of a sample from the individual would advance genetic or functional analysis of the affected relative's possible autoinflammatory condition; and\n* Ability of the subject, parents (in the case of children), to understand and the willingness to sign a written informed consent document.\n\nIn order to be eligible to participate in this study as a healthy volunteer, an individual must meet all of the following criteria:\n\n* Stated willingness to participate in study procedures for healthy volunteers;\n* Regardless of sex assigned at birth, at least five years old, and not pregnant (by history of a missed menstrual period);\n* Likelihood, in the expert opinion of the PI that a sample from the individual would advance the functional analysis of an autoinflammatory condition under study; and\n* Ability of the subject to understand and the willingness to sign a written informed consent document by a capacity assessment provided by the PI and study team.\n\nExclusion Criteria:\n\nFor any of the three categories of subjects, an individual will be excluded from participation in this study for the following reasons:\n\nProbands: an individual will not be enrolled as a proband if the study team has a low suspicion of having an autoinflammatory disease or a genetic cause for an autoinflammatory disease.\n\nFamily Members: an individual will not be enrolled as a family member if the study team believes they may have an autoinflammatory disease, in which case, they will be enrolled as a proband.\n\nHealthy controls: an individual will not be enrolled as a healthy control if they have an autoinflammatory disease, or any condition that may mimic an autoinflammatory disease, such as hematologic malignancy, rheumatologic disease.","1 Month",{"count":262,"type":21},1500,"This is an exploratory natural history protocol that will enroll patients with known genetic diseases, such as VEXAS syndrome, or as yet undiagnosed disorders of inflammation with the goal of improving our understanding of disease processes. Blood, saliva, hair, nail, or buccal samples may be collected for genetic analysis, blood samples will be obtained for immunologic and other functional studies, and a small number of subjects may undergo skin biopsy.",[265,266,27,267],"VEXAS Syndome","Autoinflammatory Disease","Rheumatic Disease",[269],"VEXAS syndrome (vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic)","2025-07-08",{"date":272,"type":40},"2025-07-09",{"date":274,"type":40},"2022-04-15",{"date":276,"type":21},"2032-04-05",{"name":278,"class":149},"NYU Langone Health",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":67,"phases":288,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":46},"100592443","autologous-cd19car-t-therapy-for-recurrentrefractory-autoimmune-diseases-100592443","NCT06993493","Autologous CD19CAR-T Therapy for Recurrent\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19 CAR - T in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Age range of 18 to 65 years old (including 18 and 65 years old), gender is not limited;\n* Special criteria for different indications:\n* Subjects with relapsed\u002Frefractory moderate to severe SLE must meet the following criteria:\n* According to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) SLE classification criteria, the diagnosis is SLE;\n* Positive for anti nuclear antibody (ANA) (titer ≥ 1:80), and\u002For positive for anti dsDNA antibody, and\u002For positive for anti Sm antibody during screening;\n* The definition of moderate to severe activity is: SLEDAI-2000 score ≥ 8 during screening; If there is a low complement and\u002For anti dsDNA antibody score, the clinical symptom score for SLEDAI-2000 (excluding low complement and\u002For anti dsDNA antibodies) must be ≥ 6 points;\n* At least 6 months of stable standard treatment have been used in the SLE history prior to screening, and the condition remains active for at least 2 months prior to screening. The standard treatment plan refers to the stable use of any of the following drugs (used alone or in combination): glucocorticoids (≤ 20mg\u002Fday prednisone or equivalent), antimalarials (hydroxychloroquine ≤ 400mg\u002Fday, chloroquine ≤ 500mg\u002Fday), nonsteroidal anti-inflammatory drugs (NSAIDs), biologics (rituximab, belimumab, tacept), and other immunosuppressants or immunomodulators, including mycophenolate mofetil (≤ 2g\u002Fday), azathioprine (≤ 2mg\u002Fkg\u002Fday), methotrexate (≤ 20mg\u002Fweek), etc;\n* Recurrent\u002Frefractory dcSSc subjects must meet the following criteria:\n* According to the 2013 EULAR\u002FACR classification criteria for systemic sclerosis (SSc), the diagnosis is SSc;\n* According to the definition criteria of LeRoy et al. in 1988, it meets the diffuse skin type presentation, which refers to extensive skin fibrosis and involvement of the skin near the elbow and\u002For knee;\n* When screening, interstitial lung disease (ILD) should be included, and 45% of the predicted values should be ≤ forced vital capacity (FVC) ≤ 70% of the predicted values, or 40% of the predicted values should be ≤ diffusion capacity of carbon monoxide (DLCO) ≤ 70% of the predicted values;\n* Relapse\u002Frefractory is defined as: recurrence after previous ineffective conventional treatment or disease remission. Conventional treatment refers to the use of glucocorticoids, cyclophosphamide, and at least one immunosuppressive\u002Fregulatory drug for at least 6 months. Immunosuppressive\u002Fregulatory drugs include azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, tacrolizumab, etc;\n* Activity is defined as having at least one of the following:\n\nThere is evidence of skin progression during screening, that is, an increase of ≥ 10% in mRSS scores within the past 6 months;\n\nDuring screening, there is evidence of any of the following ILD activities:\n\nNewly diagnosed ILD within the past 6 months; Previous ILD subjects had a 10% decrease in FVC or a 5% decrease in FVC accompanied by a 15% decrease in DLCO within the past 6 months.\n\n* Recurrent\u002Frefractory AAV subjects must meet the following criteria:\n* According to the definition of the 2012 Chapel Hill Consensus Conference (CHCC), clinical diagnosis is granulomatous vasculitis (GPA) and microscopic polyangitis (MPA);\n* In Birmingham Vasculitis Activity Score (BVAS) version 3, at least one primary item or at least three other items;\n* During screening, antibodies against PR3-ANCA or MPO-ANCA were positive;\n* The definition of recurrence\u002Frefractory is:\n\nRecurrent AAV subjects: those who have received initial efficacy (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs) after at least 3 months of combined glucocorticoid and immunosuppressive therapy (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), and have experienced at least 1 disease recurrence (recurrence defined as the appearance of at least one important item in BVAS assessment, or at least 3 other items, or 1-2 new items in two consecutive assessments), and have experienced disease recurrence within 12 weeks before screening; Difficult to treat AAV subjects: Despite at least 3 months of previous treatment with corticosteroids combined with immunosuppressants (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), no therapeutic effect has been achieved (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs);\n\n* Recurrent\u002Frefractory IIM subjects must meet the following criteria:\n* According to the 2017 EULAR\u002FACR IIM classification criteria, the probability of being diagnosed with IIM is ≥ 55%, and based on factors such as age of first onset, skin and muscle strength, laboratory tests, and muscle biopsy characteristics, it is classified as dermatomyositis (DM), polymyositis (PM), or immune-mediated necrotizing myopathy (IMNM):\n* Disease activity\u002Fseverity meets the following criteria:\n\nManual muscle strength check-8 (MMT-8) score ≤ 141 (total score of 150):\n\nMeet at least 2 of the anomalies in other CSMs:\n\nThe overall disease activity evaluated by the patient \\[based on Visual Analog Scale (VAS)\\] score is ≥ 2 points (range 0-10 points); The overall disease activity VAS score evaluated by physicians is ≥ 2 points (range 0-10 points); The overall extramuscular disease activity VAS score evaluated by the physician is ≥ 2 points (range 0-10 points); The Health Assessment Questionnaire Disability Index (HAQ-DI) score evaluated by physicians is ≥ 0.25 (range 0-3 points).\n\nAt least one muscle enzyme level is greater than 1.5 times the upper limit of normal (ULN).\n\n* Recurrent\u002Frefractory SS subjects must meet the following criteria:\n* According to the 2016 EULAR\u002FACR SS classification criteria, the diagnosis is SS;\n* Positive for anti Ro\u002FSSA antibodies during screening;\n* Dynamic saliva total flow rate ≥ 0.05 mL\u002Fmin or static saliva total flow rate ≥ 0.01 mL\u002Fmin during screening;\n* Activity is defined as a Dry Syndrome Disease Activity Index (ESSDAI) score of ≥ 5 across 8 sub items;\n* For autoimmune diseases that are intolerant to or have insufficient efficacy in the treatment of glucocorticoids and at least one other immunosuppressant or modulator in the past, it is required to be treated with glucocorticoids and at least two immunosuppressants (azathioprine, methotrexate, mycophenolate mofetil, etc.) at known effective doses for at least 3 months;\n* Having good organ function:\n* Blood routine: Absolute neutrophil count (ANC) ≥ 0.5 × 109\u002FL, platelet count (PLT) ≥ 20 × 109\u002FL, hemoglobin ≥ 60 g\u002FL;\n* Coagulation function: International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;\n* Liver function: serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN;\n* Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula) ≥ 30 mL\u002Fmin;\n* Cardiac function: NYHA grade I or II, with an echocardiogram (ECHO) left ventricular ejection fraction (LVEF) ≥ 50% and no pericardial effusion; There were no clinically significant abnormal findings in the 12 lead electrocardiogram (ECG);\n* Pulmonary function: Under indoor ventilation conditions, the oxygen saturation in non oxygenated state is ≥ 92%; No clinically significant pleural effusion;\n* Expected survival period greater than 6 months;\n* Subjects with reproductive partners agree to use effective contraceptive measures throughout the entire treatment period and for 24 months after treatment, and are not allowed to donate eggs\u002Fsperm for assisted reproduction during this period; Female subjects of childbearing age (those who have undergone sterilization surgery or have been menopausal for ≥ 12 months are not considered fertile) with negative urine pregnancy or blood pregnancy tests during the screening period; Voluntarily participate in this experiment and sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria are not eligible for inclusion in this study:\n* Patients with previous or concurrent active malignant tumors, including tumor associated polymyositis\u002Fdermatomyositis. Cervical carcinoma in situ that has been cured or has not recurred for at least 2 years, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ after radical surgery are excluded;\n* Within the past 3 months, severe pulmonary diseases such as moderate to severe pulmonary arterial hypertension (average pulmonary arterial pressure detected by echocardiography\\>60 mmHg) require oxygen mask therapy or non-invasive or invasive ventilator assisted breathing during screening; During screening, IgA, IgG, and IgM levels were below the lower limit of normal (LLN);\n* Patients who have used any of the following medications or treatments within the specified time:\n* Individuals who have used B-cell depletion therapy within the previous month and have not failed treatment as assessed by clinical physicians, including those targeting CD20, CD22, CD52, CD38, BCMA monoclonal antibodies, or bispecific antibodies;\n* Screening for excessive use of human intravenous immunoglobulin within the previous month;\n* Use therapeutic doses of corticosteroids (prednisone ≥ 20mg\u002Fday or equivalent doses of other corticosteroids) within 24 hours prior to Qinglin pretreatment;\n* Received corticosteroid shock therapy within 2 weeks (defined as a dose ≥ 500mg\u002Fd of prednisone or equivalent dose of other corticosteroids);\n* Received tacrolizumab within 2 weeks prior to screening, or received belimumab within 3 weeks;\n* Patients with a history of severe central nervous system diseases or related symptoms (excluding simple trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease and other central nervous system diseases, as well as epilepsy, seizures, aphasia, dementia and other symptoms;\n* Individuals who have experienced lupus crisis within the previous 3 months, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe neutropenia, severe myocardial injury, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc;\n* Concurrent severe kidney disease: severe lupus nephritis (defined as urinary protein\\>4g\u002F24 hours or serum creatinine\\>1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula)\\\u003C30 mL\u002Fmin) within the first 8 weeks of screening, Or active nephritis that requires treatment with drugs prohibited by the protocol, or requires treatment with prednisone greater than 500mg\u002Fday or equivalent corticosteroids for ≥ 14 days;\n* Those who have severe allergies to the Qinglin pre-treatment drugs and any components of autologous CD19 CAR-T used in this study;\n* hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA positive; Individuals with positive hepatitis C virus (HCV) antibodies and positive HCV RNA; Positive for Treponema pallidum antibody; HIV antibody positive individuals;\n* There are uncontrolled fungi, bacteria, viruses, or other infections that researchers have assessed as unsuitable for participation in the study;\n* History of major organ transplantation (such as heart and lung); During screening, there is active tuberculosis or latent tuberculosis (referring to whether the tuberculin skin test or interferon test is positive, and there are no clinical symptoms or imaging evidence);\n* If any of the following cardiovascular diseases (including but not limited to) have occurred within the 6 months prior to screening:\n* Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary artery\u002Fperipheral artery bypass grafting;\n* Serious arrhythmias that require treatment (such as persistent ventricular tachycardia, ventricular fibrillation, apical torsion ventricular tachycardia, etc.); Congenital long QT syndrome, left anterior half block (double bundle block), allowing asymptomatic right bundle branch block to be included in the study;\n* Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and\u002For diastolic blood pressure greater than 100 mmHg), history of hypertensive crisis or hypertensive encephalopathy;\n* In addition to the target indication, patients with a history of other autoimmune diseases (including but not limited to eosinophilic granulomatous polyangitis, cryoglobulinemia vasculitis, inclusion body myositis, anti glomerular basement membrane disease, Behcet's disease or Takayasu arteritis, etc.) who require systematic treatment;\n* Individuals with a family history of non IIM such as drug-induced myopathy or human immunodeficiency virus related myopathy;\n* Pregnant or lactating women;\n* Those who have received a live vaccine within 6 weeks before the pre-treatment of Qinglin;\n* Participants who have participated in other interventional clinical studies, received active investigational drug treatment, or intended to participate in another clinical trial or receive treatment for autoimmune diseases outside of the protocol within 3 months prior to signing the informed consent form during the entire study period;\n* Mental illness patients with depression or suicidal tendencies; The researchers believe that there are other factors that are not suitable for inclusion or affect the participation or completion of the study by the subjects.","65 Years",{"count":186,"type":21},[289],"NA","This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of autologous CD19 CAR-T therapy in subjects with autoimmune diseases.\n\nThe study will adopt the traditional dose escalation model \"3+3\" design, with three dose groups set up, starting at a dose of 0.5 × 106 CAR+T cells\u002Fkg, to observe DLT, and conduct a 24 month safety and efficacy follow-up after cell infusion to observe the safety of autologous CD19 CAR-T and conduct preliminary efficacy evaluation.\n\nThree dose groups were set up, with dose group 1 as the starting dose, following the traditional 3+3 design rule for a single intravenous infusion:\n\nDose group dosage unit (CAR+T cells\u002Fkg) Acceptable dose range Expected sample size (± 30%, CAR+T cells\u002Fkg)\n\n1. 0.5 × 106 0.4 × 106\\~0.6 × 106 3-6 cases\n2. 1.0 × 106 0.7 × 106\\~1.3 × 106 3-6 cases\n3. 2.0 × 106 1.4 × 106\\~2.6 × 106 3-6 cases Dose escalation rule The enrollment starts from dose group 1, and if no DLT occurs in the 3 subjects included, they will be transferred to the next dose group. If one of the three subjects in a certain dose group develops DLT, three additional subjects will be added to the group for cell infusion at the same dose. If there is ≥ 1 case of DLT in the 3 additional cases, it will be reduced to the previous dose group. If there are only 3 subjects in the previous dose group at this time, an additional 3 subjects need to be added for the trial; If there are already 6 subjects in the previous dose group, the trial ends and this dose is the maximum tolerated dose (MTD).\n\nDose escalation is not allowed for the same subject. For safety reasons, the last subject in the previous dose group was observed for at least 28 days after autologous CD19 CAR-T infusion without DLT. The Safety Review Committee (SRC) held a meeting to decide whether to increase to the next dose group.\n\nDuring the dose escalation phase, SRC determines whether to continue increasing the dose or explore more subjects in a previously explored dose group based on the safety, efficacy, and pharmacokinetic (PK) results obtained for each dose group, and determines the recommended dose (RD) for subsequent studies.",[27],"2025-05-20",{"date":294,"type":40},"2025-05-28",{"date":296,"type":40},"2025-02-20",{"date":298,"type":21},"2027-08-31",{"name":300,"class":149},"Beijing Boren Hospital",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":286,"enrollmentInfo":308,"targetDuration":4,"studyType":67,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":316,"leadSponsor":318,"locationsCount":46},"100591710","safety-and-efficacy-of-cd19-car-t-therapy-for-recurrentrefractory-autoimmune-diseases-100591710","NCT06983964","Safety and Efficacy of CD19 CAR-T Therapy for Recurrent\u002FRefractory Autoimmune Diseases","Exploratory Clinical Study Evaluating the Safety and Efficacy of Universal CD19 CAR-T Therapy for Recurrent\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Participants must meet all of the following inclusion criteria in order to be included in this study;\n* Age range of 18 to 65 years old (including 18 and 65 years old), gender is not limited;\n* Special criteria for different indications:\n* Subjects with relapsed\u002Frefractory moderate to severe SLE must meet the following criteria:\n* According to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) SLE classification criteria, the diagnosis is SLE;\n* Positive for anti nuclear antibody (ANA) (titer ≥ 1:80), and\u002For positive for anti dsDNA antibody, and\u002For positive for anti Sm antibody during screening;\n* The definition of moderate to severe activity is: SLEDAI-2000 score ≥ 8 during screening; If there is a low complement and\u002For anti dsDNA antibody score, the clinical symptom score for SLEDAI-2000 (excluding low complement and\u002For anti dsDNA antibodies) must be ≥ 6 points;\n* At least 6 months of stable standard treatment have been used in the SLE history prior to screening, and the condition remains active for at least 2 months prior to screening. The standard treatment plan refers to the stable use of any of the following drugs (used alone or in combination): glucocorticoids (≤ 20mg\u002Fday prednisone or equivalent), antimalarials (hydroxychloroquine ≤ 400mg\u002Fday, chloroquine ≤ 500mg\u002Fday), nonsteroidal anti-inflammatory drugs (NSAIDs), biologics (rituximab, belimumab, tacept), and other immunosuppressants or immunomodulators, including mycophenolate mofetil (≤ 2g\u002Fday), azathioprine (≤ 2mg\u002Fkg\u002Fday), methotrexate (≤ 20mg\u002Fweek), etc;\n* Recurrent\u002Frefractory dcSSc subjects must meet the following criteria:\n* According to the 2013 EULAR\u002FACR classification criteria for systemic sclerosis (SSc), the diagnosis is SSc; 2) According to the definition criteria of LeRoy et al. in 1988, it meets the diffuse skin type presentation, which refers to extensive skin fibrosis and involvement of the skin near the elbow and\u002For knee;\n* When screening, interstitial lung disease (ILD) should be included, and 45% of the predicted values should be ≤ forced vital capacity (FVC) ≤ 70% of the predicted values, or 40% of the predicted values should be ≤ diffusion capacity of carbon monoxide (DLCO) ≤ 70% of the predicted values;\n* Relapse\u002Frefractory is defined as: recurrence after previous ineffective conventional treatment or disease remission. Conventional treatment refers to the use of glucocorticoids, cyclophosphamide, and at least one immunosuppressive\u002Fregulatory drug for at least 6 months. Immunosuppressive\u002Fregulatory drugs include azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, tacrolizumab, etc;\n* Activity is defined as having at least one of the following:\n\nThere is evidence of skin progression during screening, that is, an increase of ≥ 10% in mRSS scores within the past 6 months;\n\nDuring screening, there is evidence of any of the following ILD activities:\n\nNewly diagnosed ILD within the past 6 months; Previous ILD subjects had a 10% decrease in FVC or a 5% decrease in FVC accompanied by a 15% decrease in DLCO within the past 6 months.\n\n* Recurrent\u002Frefractory AAV subjects must meet the following criteria:\n* According to the definition of the 2012 Chapel Hill Consensus Conference (CHCC), clinical diagnosis is granulomatous vasculitis (GPA) and microscopic polyangitis (MPA);\n* In Birmingham Vasculitis Activity Score (BVAS) version 3, at least one primary item or at least three other items;\n* During screening, antibodies against PR3-ANCA or MPO-ANCA were positive;\n* The definition of recurrence\u002Frefractory is:\n\nRecurrent AAV subjects: those who have received initial efficacy (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs) after at least 3 months of combined glucocorticoid and immunosuppressive therapy (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), and have experienced at least 1 disease recurrence (recurrence defined as the appearance of at least one important item in BVAS assessment, or at least 3 other items, or 1-2 new items in two consecutive assessments), and have experienced disease recurrence within 12 weeks before screening; Difficult to treat AAV subjects: Despite at least 3 months of previous treatment with corticosteroids combined with immunosuppressants (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), no therapeutic effect has been achieved (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs);\n\n* Recurrent\u002Frefractory IIM subjects must meet the following criteria:\n* According to the 2017 EULAR\u002FACR IIM classification criteria, the probability of being diagnosed with IIM is ≥ 55%, and based on factors such as age of first onset, skin and muscle strength, laboratory tests, and muscle biopsy characteristics, it is classified as dermatomyositis (DM), polymyositis (PM), or immune-mediated necrotizing myopathy (IMNM):\n* Disease activity\u002Fseverity meets the following criteria:\n\nManual muscle strength check-8 (MMT-8) score ≤ 141 (total score of 150):\n\nMeet at least 2 of the anomalies in other CSMs:\n\nThe overall disease activity evaluated by the patient \\[based on Visual Analog Scale (VAS)\\] score is ≥ 2 points (range 0-10 points); The overall disease activity VAS score evaluated by physicians is ≥ 2 points (range 0-10 points); The overall extramuscular disease activity VAS score evaluated by the physician is ≥ 2 points (range 0-10 points); The Health Assessment Questionnaire Disability Index (HAQ-DI) score evaluated by physicians is ≥ 0.25 (range 0-3 points).\n\nAt least one muscle enzyme level is greater than 1.5 times the upper limit of normal (ULN).\n\n* Recurrent\u002Frefractory SS subjects must meet the following criteria:\n* According to the 2016 EULAR\u002FACR SS classification criteria, the diagnosis is SS;\n* Positive for anti Ro\u002FSSA antibodies during screening;\n* Dynamic saliva total flow rate ≥ 0.05 mL\u002Fmin or static saliva total flow rate ≥ 0.01 mL\u002Fmin during screening;\n* Activity is defined as a Dry Syndrome Disease Activity Index (ESSDAI) score of ≥ 5 across 8 sub items;\n* For autoimmune diseases that are intolerant to or have insufficient efficacy in the treatment of glucocorticoids and at least one other immunosuppressant or modulator in the past, it is required to be treated with glucocorticoids and at least two immunosuppressants (azathioprine, methotrexate, mycophenolate mofetil, etc.) at known effective doses for at least 3 months;\n* Having good organ function:\n* Blood routine: Absolute neutrophil count (ANC) ≥ 0.5 × 109\u002FL, platelet count (PLT) ≥ 20 × 109\u002FL, hemoglobin ≥ 60 g\u002FL;\n* Coagulation function: International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;\n* Liver function: serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN;\n* Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula) ≥ 30 mL\u002Fmin;\n* Cardiac function: NYHA grade I or II, with an echocardiogram (ECHO) left ventricular ejection fraction (LVEF) ≥ 50% and no pericardial effusion; There were no clinically significant abnormal findings in the 12 lead electrocardiogram (ECG);\n* Pulmonary function: Under indoor ventilation conditions, the oxygen saturation in non oxygenated state is ≥ 92%; No clinically significant pleural effusion;\n* Expected survival period greater than 6 months;\n* Subjects with reproductive partners agree to use effective contraceptive measures throughout the entire treatment period and for 24 months after treatment, and are not allowed to donate eggs\u002Fsperm for assisted reproduction during this period; Female subjects of childbearing age (those who have undergone sterilization surgery or have been menopausal for ≥ 12 months are not considered fertile) with negative urine pregnancy or blood pregnancy tests during the screening period; Voluntarily participate in this experiment and sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria are not eligible for inclusion in this study:\n* Patients with previous or concurrent active malignant tumors, including tumor associated polymyositis\u002Fdermatomyositis. Cervical carcinoma in situ that has been cured or has not recurred for at least 2 years, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ after radical surgery are excluded;\n* Within the past 3 months, severe pulmonary diseases such as moderate to severe pulmonary arterial hypertension (average pulmonary arterial pressure detected by echocardiography\\>60 mmHg) require oxygen mask therapy or non-invasive or invasive ventilator assisted breathing during screening; During screening, IgA, IgG, and IgM levels were below the lower limit of normal (LLN);\n* Patients who have used any of the following medications or treatments within the specified time:\n* Individuals who have used B-cell depletion therapy within the previous month and have not failed treatment as assessed by clinical physicians, including those targeting CD20, CD22, CD52, CD38, BCMA monoclonal antibodies, or bispecific antibodies;\n* Screening for excessive use of human intravenous immunoglobulin within the previous month;\n* Use therapeutic doses of corticosteroids (prednisone ≥ 20mg\u002Fday or equivalent doses of other corticosteroids) within 24 hours prior to Qinglin pretreatment;\n* Received corticosteroid shock therapy within 2 weeks (defined as a dose ≥ 500mg\u002Fd of prednisone or equivalent dose of other corticosteroids);\n* Received tacrolizumab within 2 weeks prior to screening, or received belimumab within 3 weeks;\n* Patients with a history of severe central nervous system diseases or related symptoms (excluding simple trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease and other central nervous system diseases, as well as epilepsy, seizures, aphasia, dementia and other symptoms;\n* Individuals who have experienced lupus crisis within the previous 3 months, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe neutropenia, severe myocardial injury, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc;\n* Concurrent severe kidney disease: severe lupus nephritis (defined as urinary protein\\>4g\u002F24 hours or serum creatinine\\>1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula)\\\u003C30 mL\u002Fmin) within the first 8 weeks of screening, Or active nephritis that requires treatment with drugs prohibited by the protocol, or requires treatment with prednisone greater than 500mg\u002Fday or equivalent corticosteroids for ≥ 14 days;\n* Individuals who have severe allergies to any components of the Qinglin pre-treatment drug and the universal CD19 CAR-T used in this study;\n* hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA positive; Individuals with positive hepatitis C virus (HCV) antibodies and positive HCV RNA; Positive for Treponema pallidum antibody; HIV antibody positive individuals;\n* There are uncontrolled fungi, bacteria, viruses, or other infections that researchers have assessed as unsuitable for participation in the study;\n* History of major organ transplantation (such as heart and lung);\n* During screening, there is active tuberculosis or latent tuberculosis (referring to whether the tuberculin skin test or interferon test is positive, and there are no clinical symptoms or imaging evidence);\n* If any of the following cardiovascular diseases (including but not limited to) have occurred within the 6 months prior to screening:\n* Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary artery\u002Fperipheral artery bypass grafting;\n* Serious arrhythmias that require treatment (such as persistent ventricular tachycardia, ventricular fibrillation, apical torsion ventricular tachycardia, etc.); Congenital long QT syndrome, left anterior half block (double bundle block), allowing asymptomatic right bundle branch block to be included in the study;\n* Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and\u002For diastolic blood pressure greater than 100 mmHg), history of hypertensive crisis or hypertensive encephalopathy;\n* In addition to the target indication, patients with a history of other autoimmune diseases (including but not limited to eosinophilic granulomatous polyangitis, cryoglobulinemia vasculitis, inclusion body myositis, anti glomerular basement membrane disease, Behcet's disease or Takayasu arteritis, etc.) who require systematic treatment;\n* Individuals with a family history of non IIM such as drug-induced myopathy or human immunodeficiency virus related myopathy;\n* Pregnant or lactating women;\n* Those who have received a live vaccine within 6 weeks before the pre-treatment of Qinglin;\n* Participants who have participated in other interventional clinical studies, received active investigational drug treatment, or intended to participate in another clinical trial or receive treatment for autoimmune diseases outside of the protocol within 3 months prior to signing the informed consent form during the entire study period;\n* Mental illness patients with depression or suicidal tendencies; The researchers believe that there are other factors that are not suitable for inclusion or affect the participation or completion of the study by the subjects.",{"count":186,"type":21},[289],"This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases.\n\nThe study will adopt the traditional dose escalation model \"3+3\" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells\u002Fkg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.",[27],"2025-05-14",{"date":314,"type":40},"2025-05-21",{"date":296,"type":40},{"date":317,"type":21},"2027-09-30",{"name":300,"class":149},{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":286,"enrollmentInfo":326,"targetDuration":4,"studyType":67,"phases":328,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":4},"100564735","phase-1-the-safety-and-efficacy-of-universal-car-t-cells-targeting-bcma-in-the-treatment-of-refractory-nmosd-100564735","NCT06633042","The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD","The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disease","Inclusion Criteria:\n\n* Aged 18-65 years ; both genders eligible.\n* Meets the criteria for Refractory NMOSD.\n* Anticipated survival of ≥ 12 weeks as judged by the researcher.\n* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* History of solid organ transplantation.\n* Malignant tumor within the last two years.\n* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.\n* Primary immunodeficiency (congenital or acquired).\n* Severe cardiac disease.\n* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.\n* Allergic constitution or a history of severe allergies.\n* Pregnant or breastfeeding women.",{"count":327,"type":21},18,[69],"This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.",[27],[332,333,334],"Universal BCMA CART","AQP4 Antibody Positive","RefractoryNeuromyelitis Optica Spectrum Disease","2024-11-07",{"date":337,"type":40},"2024-11-12",{"date":339,"type":21},"2024-11-25",{"date":341,"type":21},"2025-12-12",{"name":343,"class":204},"Bioray Laboratories"]