[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-disorders":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,77,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100600919","phase-2-ublituximab-in-autoantibody-positive-immune-mediated-necrotizing-myopathy-100600919",false,"NCT07103746","Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy","Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)","SUMMIT","Inclusion Criteria:\n\n1. Participant must be able to understand and provide informed consent.\n2. Age 18 years or older at disease onset.\n3. Definite or probable IIM per the 2017 EULAR\u002FACR classification criteria.\n4. Diagnosis of IMNM, meeting the 2016 ENMC classification criteria and having either of the following antibodies:\n\n   1. Anti-SRP\n   2. Anti-HMGCR\n5. Early disease as defined as onset of objective muscle weakness assessed by a physician and\u002For CK elevation attributed to IMNM within 1 year of the time of informed consent.\n6. Muscle weakness as assessed by an MMT-8 score \\\u003C 142 of 150 and CK \\> 1.5x ULN along with abnormality in at least 1 of the following 4 CSMs at screening:\n\n   1. PhGA ≥ 2 cm\n   2. PtGA ≥ 2 cm\n   3. Extramuscular global assessment ≥ 2 cm\n   4. HAQ-DI ≥ 0.25\n7. Treatment with only one of the following background immunosuppressant medications for IMNM for at least 12 weeks prior to randomization and the same dose for at least 4 weeks prior to randomization:\n\n   1. Methotrexate up to 25 mg weekly\n   2. Mycophenolate mofetil up to 3000 mg daily\n   3. Mycophenolic acid up to 2160 mg daily\n   4. Azathioprine up to 2.5 mg\u002Fkg daily\n   5. Tacrolimus up to 0.2 mg\u002Fkg daily\n   6. Cyclosporine up to 5 mg\u002Fkg daily\n8. Current therapy consisting of glucocorticoid ≤ 20 mg\u002Fday of prednisone. The dose must be stable for at least 4 weeks prior to randomization. Participants who stopped treatment with glucocorticoids are eligible if the last dose of the glucocorticoids was at least 4 weeks before the time of informed consent.\n9. Female participants of childbearing potential and male participants with a partner of childbearing potential must agree to consistently and correctly use FDA approved highly effective methods of birth control, as shown in Appendix 1: Acceptable Contraception Methods for Females of Reproductive Potential, for the entire duration of the study and 6 months after last study drug infusion. Female participants of reproductive potential must have a negative pregnancy test at screening and at baseline.\n\nExclusion Criteria:\n\n1. End-stage myositis with end-organ involvement that poses additional risk to the participant or confounds the assessment of the participant in the study. Conditions include but are not limited to advanced symptomatic interstitial lung disease (e.g., Forced Vital Capacity (FVC) \\\u003C60% and\u002For requiring oxygen therapy) or severe dysphagia.\n2. Irreversible muscle involvement and\u002For severe atrophy that will pose additional risk to the participant or confound the assessment of the participant in the study. This includes Muscle Damage VAS ≥ 3 cm at screening, documented history of severe atrophy of multiple muscle groups (based on MRI), and\u002For wheelchair bound.\n3. Uncontrolled interstitial lung disease or any other uncontrolled IIM manifestation that in the opinion of the investigator would be likely to require treatment with prohibited medication during the study.\n4. Diagnosis of other inflammatory or noninflammatory myopathies, including antibody-negative IMNM, inclusion body myositis, overlap myositis, metabolic myopathies, muscular dystrophies or family history of muscular dystrophy, drug induced, cancer-associated myositis, or endocrine-based myositis (except statin induced anti-HMGCR associated IMNM).\n5. Severe liver disease, such as signs of ascites or hepatic encephalopathy.\n6. History of malignancy (excluding non-melanoma skin cancer) unless cured by adequate treatment, with no evidence of recurrence for ≥ 5 years from the time of informed consent.\n7. Recent or ongoing bacterial, viral, or fungal infection requiring systemic treatment within 14 days of the time of informed consent.\n8. Current suppressive therapy for any chronic infections including herpes simplex virus (HSV).\n9. Infection with Mycobacterium tuberculosis (TB) as defined by any of the following:\n\n   1. Positive interferon gamma release assay (IGRA) performed at screening or within 12 weeks prior to the time of informed consent.\n   2. Indeterminate IGRAs must be repeated (with same or other IGRA per local policy) and shown to be negative. Alternatively, if the assay remains indeterminant, a participant must have a negative purified protein derivative (PPD) skin test. Finally, if the participant has had the Bacille Calmette-Guerin (BCG) vaccine or has some other condition complicating the interpretation of TB testing, consultation with infectious disease specialist must be obtained before randomization.\n10. Medical history or serologic evidence at screening of chronic infections, including:\n\n    a. Human immunodeficiency virus (HIV) infection b. Hepatitis B virus (HBV) as indicated by surface antigen or hepatitis B core antibody positivity c. Hepatitis C virus (HCV) as indicated by anti-hepatitis C antibody positivity. If a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if they have a negative viral load at Screening.\n11. Known hypersensitivity reaction to ublituximab.\n12. Received a live or live-attenuated vaccine \\\u003C 4 weeks before the time of informed consent. Received any other type of vaccine \\\u003C 2 weeks before the time of informed consent.\n13. Any of the following laboratory tests at screening:\n\n    a. Hemoglobin \\\u003C 10 g\u002FdL b. Absolute white blood cell count \\\u003C 3,000 cells\u002Fmm3 c. Platelet count \\\u003C 100,000 cells\u002Fmm3 d. Absolute neutrophils \\\u003C 1,500 cell\u002Fmm3 e. Peripheral B-cell \\\u003C 40 cells\u002FµL f. IgG \\\u003C 690 mg\u002FdL g. Estimated GFR \\\u003C 50 mL\u002Fmin\u002F1.73 m2\n14. Treatment with any immunosuppressive or immunomodulatory agent, such as cyclophosphamide, biologics, and Janus kinase (JAK) inhibitors, except those listed in the inclusion criteria 7 within 12 weeks prior to randomization.\n15. Prior receipt of B-cell depleting agents such as rituximab, ocrelizumab, ofatumumab, or belimumab at any time.\n16. Treatment of IMNM with IVIG or subcutaneous immunoglobulin (SCIG) within 12 weeks of randomization, or prior receipt of more than one cycle of IVIG at any time.\n17. Participant has current or history (within 12 months of screening) of alcohol, drug, or medication abuse.\n18. Participant is pregnant or lactating or intends to become pregnant during the study.\n19. Use of any investigational drug within 24 weeks of the time of informed consent.\n20. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy.\n\nThe primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early, active autoantibody positive immune-mediated necrotizing myopathy using the validated 2016 American College of Rheumatology\u002F European League Against Rheumatism (ACR\u002FEULAR) Myositis Response Criteria, as measured by the Total Improvement Score (TIS)",[27],"Autoimmune Disorders",[29,30,31],"Ublituximab","Active Autoantibody Positive Immune-Mediated Necrotizing Myopathy (IMNM)","Idiopathic inflammatory myopathies (IIM)","RECRUITING","2026-06-12",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2026-02-26",{"date":40,"type":21},"2029-08",{"name":42,"class":43},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",8,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100283686","testicular-tissue-cryopreservation-for-fertility-preservation-100283686","NCT02972801","Testicular Tissue Cryopreservation for Fertility Preservation","Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens","Inclusion Criteria:\n\n* Be male at any age.\n* Be scheduled to undergo surgery, chemotherapy, drug treatment and\u002For radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function.\n* Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles.\n* Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function.\n* Have two testicles if undergoing elective removal of all or part of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options.\n* Sign an approved informed consent and authorization permitting the release of personal health information. The patient and\u002For the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and\n* Consent for serum screening tests for infectious diseases \\[HIV-1, HIV-2, Hepatitis B, Hepatitis C\\], to be performed at the time of testicular tissue harvesting.\n* Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent ACC\u002FAHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.\n* Participating in long term follow-up is a requirement of the protocol.\n\nExclusion Criteria:\n\n* Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.\n* Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.","MALE",{"count":54,"type":21},1500,[56],"NA","Testicular tissue cryopreservation is an experimental procedure where a young boy's testicular tissue is retrieved and frozen. This technique is reserved for young male patients who are not yet producing mature sperm, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline.",[59,27],"Cancer",[61,62,63,64,65],"Spermatogonial stem cells","Testis","Fertility","Infertility","Oncofertility","2026-04-18",{"date":68,"type":36},"2026-04-22",{"date":70,"type":36},"2010-01-06",{"date":72,"type":21},"2030-05-31",{"name":74,"class":75},"University of Pittsburgh","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100549464","phase-1-phase-iii-study-of-ad-plureceptor-plus-tafasitamab-cxix-and-lymphodepleting-chemotherapy-in-patients-with-autoimmune-disorders-100549464","NCT06434363","Phase I\u002FII Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders","Inclusion Criteria:\n\nSSc Specific Inclusion Criteria\n\nA. Diagnosis of SSc defined as follows:\n\ni) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening.\n\nB. SSc disease activity i) Diffuse SSc meeting the following criteria:\n\n(1) Disease duration ≤ 7 years (from onset of first non-Raynaud manifestation) AND (2) mRSS ≥ 15 at screening (Appendix 1) OR ii) Participants diagnosed with diffuse or limited cutaneous SSc AND presence of ILD changes on HRCT AND Disease duration ≤ 7 years (from onset of first non- Raynaud manifestation) AND either (1) or (2)\n\n1. Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):\n\n   (a) worsening respiratory symptoms (b) physiological evidence of disease progression (≥ 1 of the following): (i) Absolute decline in FVC ≥ 5% predicted within 1 year of follow-up (ii) Absolute decline in DLCO (corrected for Hb) ≥ 10% predicted within 1 year of follow-up radiological evidence of disease progression (c) radiological evidence of disease progression (≥ 1 of the following):\n\n   (i) Increased extent or severity of traction bronchiectasis and bronchiolectasis.\n\n   (ii) New ground-glass opacity with traction bronchiectasis (iii) New fine reticulation (iv) Increased extent or increased coarseness of reticular abnormality.\n\n   (v) New or increased honeycombing (vi) Increased lobar volume loss\n2. FVC \\\u003C 80% predicted or extent of ILD changes on HRCT \\> 20%. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and\u002For tocilizumab\n\nSLE Specific Inclusion Criteria\n\n1. A clinical diagnosis of SLE, based on the 2019 EULAR\u002F ACR classification criteria for adult SLE.\n2. Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening or prior to screening.\n3. For LN subjects only: Active, biopsy-proven lupus nephritis (kidney biopsy should have been done within 1 year of study enrollment) class III or IV, with or without the presence of Class V, using the 2018 Revised International Society of Nephrology\u002FRenal Pathology Society criteria48.\n4. Diagnosed with active SLE. Subjects with either LN or without LN will be eligible if they meet the following criteria:\n\n   a. For LN subjects: urine protein-to-creatinine ratio (UPCR) ≥0.5 g\u002Fg on 2 first morning void urine samples during screening despite prior or current treatment with standard of care therapy for at least 12 weeks, including corticosteroids, MMF\u002Fmycophenolic acid (MPA), CY, calcineurin inhibitors, belimumab, and\u002For rituximab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, b. For non-renal SLE subjects: SLEDAI-2K ≥8 and clinical SLEDAI-2K ≥6 (excluding headache, alopecia, mucosal ulcers, fever, and organic brain syndrome) or ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and\u002For constitutional organ system) during screening despite prior or current treatment with standard of care therapy, including corticosteroids, rituximab or other B cell depleting agents, CY, MMF\u002FMPA, azathioprine, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, mizorbine, anifrolumab, and\u002For belimumab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, or failed due to intolerance, or unable to obtain medication.\n5. If a subject is currently receiving:\n\n   1. A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject must be on a stable dose for at least 8 weeks prior to screening. A sodium-glucose cotransporter-2 (SGLT2) inhibitor, the subject must be on a stable dose for at least 8 weeks prior to screening.\n   2. Regarding oral corticosteroid, doses \\\u003C0.5 mg\u002Fkg prednisone equivalent at the time of enrollment are required. Steroid taper to ≤10 mg prednisone equivalent prior to lymphodepleting chemotherapy is recommended.\n\nChronic GVHD specific inclusion criteria\n\n1. The patient has a history of steroid resistant chronic graft versus host disease (SR- chronic GVHD) or is intolerant of or has unacceptable complications with steroids.\n\n   Definition of SR-chronic GVHD - Chronic GVHD that does not respond adequately to full-dose prednisone. Any of the following conditions would be considered SR-chronic GVHD:\n   * Progressive symptoms \u002F manifestations of chronic GVHD despite receiving prednisone 1 mg\u002Fkg\u002Fday (or equivalent) for two weeks\n   * Stable symptoms \u002F manifestations of chronic GVHD after four to six weeks of prednisone ≥0.5 mg\u002Fkg\u002Fday (or equivalent)\n   * Inability to taper prednisone to \\\u003C0.5 mg\u002Fkg\u002Fday (or equivalent) without worsening of symptoms \u002F manifestations of chronic GVHD\n2. Disease activity:\n\n   • Manifestations\u002Fsymptoms of chronic GVHD rated as moderate to severe on the NIH chronic GVHD global severity score.\n3. Manifestations\u002Fsymptoms of chronic GVHD that have not adequately responded or intolerant to both:\n\n   * Ruxolitinib\n   * Belumosudil.\n4. May be receiving adrenal replacement doses of corticosteroids\n\nInclusion Criteria: For SLE, SSc, and chronic GVHD\n\n1. Able to provide informed consent.\n2. Age ≥18 to ≤80 years.\n3. Adequate organ function i) Peripheral blood absolute neutrophil count (ANC) ≥ 1 × 109\u002FL, unless the neutropenia is deemed to be caused by the underlying autoimmune disease.\n\nii) Hemoglobin ≥ 8 g\u002Fdl, unless the anemia is deemed to be caused by the underlying autoimmune disease.\n\niii) Platelet count ≥ 50 × 109\u002FL without platelet transfusion support, unless the thrombocytopenia is deemed to be caused by the underlying autoimmune disease. No clinically significant active bleeding.\n\niv) Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) and total bilirubin ≤ 3 × ULN (or direct bilirubin ≤ 3 × ULN with documented Gilbert's syndrome).\n\nv) Oxygen saturation (SaO2) ≥ 92% on room air (as measured by forehead probes in SSc patients).\n\nvi) Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n\nvii) Adequate renal function, defined as serum creatinine ≤ 2x ULN and estimated Glomerular Filtration Rate (eGFR using the CKD-EPI equation) ≥ 30 ml\u002Fmin\u002F1.73 m2 5. Recovery to ≤ Grade 1 or baseline of any non-hematological toxicities due to prior therapy.\n\n6\\. Negative pregnancy test in WOCBP. 7. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of therapy. Acceptable forms of birth control for female patients include hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor. Participant is willing and able to adhere to the study visit schedule and other protocol requirements and willing to sign informed consent.\n\nExclusion Criteria:\n\nSSc specific exclusion criteria\n\n1. SSc related pulmonary arterial hypertension (PAH) requiring active treatment.\n2. Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.\n3. Prior scleroderma renal crisis.\n4. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\\u003C 40% or FVC \\\u003C 40% of predicted or O2 saturation \\\u003C 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.\n\n   SLE specific Exclusion Criteria\n\n   Subjects are excluded from the study if any of the following criteria apply:\n5. For LN subjects only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following\n\n   individual biopsy features: total glomerulosclerosis score, fibrous crescents, tubular atrophy, or interstitial fibrosis.\n6. The presence of biopsy-proven kidney disease other than active lupus nephritis\n7. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\\u003C 40% or FVC \\\u003C 40% of predicted or O2 saturation \\\u003C 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.Active, severe cardiac manifestations of SLE, including constrictive pericarditis, hemodynamically significant pericardial effusions, and myocarditis at the time of screening.\n\n   Exclusion Criteria for Chronic GVHD\n8. Treatment with any immunosuppressive drug (except steroids) within 5 half lives prior to administration of lymphodepleting therapy.\n\n   Immunosuppressive Drug Five Half Lives Half Life of the Drug Axatilimab 23 days 108 hours Belumosudil 4 days 19 hours Cyclophosphamide 3 days 3-12 hours Ibrutinib 2 days 4-6 hours Ruxolitinib 2 days 5.8 hours Sirolimus 13 days 62 hours Tacrolimus 8 days 2.1-36 hours Tocilizumab 9 weeks 5-13 days\n9. Receiving any immunosuppressive medications that are not being used for management of chronic GVHD.\n10. Treatment with steroids ≥0.5 mg\u002Fkg prednisone daily or equivalent at the time of enrollment and \\>10 mg prednisone daily or equivalent at the time of lymphodepletion.\n11. Received rituximab within 6 months of lymphodepletion.\n\n    Exclusion Criteria for SLE, SSc, and chronic GVHD\n\n    Subjects are excluded from the study if any of the following medical conditions apply:\n12. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.\n13. Active, clinically significant central nervous system pathology\n14. Prior history of malignancies or lymphoproliferative disease, following are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or breast or Smoldering Myeloma. History of malignancy that has been treated with a curative intent and is in remission may be allowed after discussion with PI.\n15. Active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and\u002For type 2 (HTLV-1 and\u002For HTLV-2\n16. Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti- infective treatment at screening or within 72 hours before LD chemotherapy, or 5 days before AD-PluReceptor administration.\n17. History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n18. Prior CAR T cell therapy, genetically modified T cell therapy.\n19. Treatment with cyclophosphamide within 3 days, tocilizumab within 9 weeks, and\u002For any other immunosuppressive drug (excluding steroids) within 5 half-lives prior to administration of lymphodepleting chemotherapy. Immunosuppressive medications are allowed if not being used for management of SLE, LN or SSc.\n20. Treatment with mycophenolate mofetil within 4 days prior to administration of lymphodepleting chemotherapy. For patients who will receive tafasitamab alone may continue mycophenolate mofetil throughout the study.\n21. History of anaphylactic or severe systemic reaction to FLU, CY, Tafasitamab, or any of their metabolites.\n22. Uncontrolled infection at screening.\n23. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (on TPN), pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n24. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures.",{"count":84,"type":21},47,[86,24],"PHASE1","The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.\n\nThe goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.\n\nThe goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.",[27,89,90,91,92],"Systemic Sclerosis","Systemic Lupus Erythematosus","Lupus","Lupus Nephritis",[94],"CAR NK, CAR, Natural Killer, SSc, SLE, LN, GVHD, Chronic GVHD","2026-04-10",{"date":97,"type":36},"2026-04-15",{"date":99,"type":36},"2024-07-31",{"date":101,"type":21},"2030-12-31",{"name":103,"class":75},"M.D. Anderson Cancer Center",2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":44},"100490871","phase-1-daratumumab-in-primary-antiphospholipid-syndrome-100490871","NCT05671757","Daratumumab in Primary Antiphospholipid Syndrome","Targeting CD38 With Daratumumab in Primary Antiphospholipid Syndrome: A Phase 1b Dose Escalation Safety Trial (ITN093AI)","DARE-APS","Inclusion Criteria:\n\n1. Adults 18 to 70 years of age, inclusive.\n2. The completion of the following vaccinations at least 14 days prior to Visit 0:\n\n   1. At least one dose of the most recently updated COVID-19 vaccine, and\n   2. At least one dose of the herpes zoster vaccination series, and\n   3. Current seasonal influenza vaccine, if available.\n3. History of APS according to the updated 2006 Sapporo classification criteria, including at least one of the following:\n\n   a. Arterial thrombosis, except transient ischemic attack, confirmed by objective validated criteria such as imaging, or b. Venous thrombosis, except superficial thrombophlebitis, confirmed by objective validated criteria such as imaging, or c. Pregnancy morbidity, based on the updated 2006 Sapporo APS classification criteria, or d. Microvascular APS, with at least one of the following: i. Renal biopsy documentation of aPL-associated nephropathy, or ii. Lung biopsy or bronchoalveolar lavage documentation of diffuse alveolar hemorrhage (DAH), or iii. Skin biopsy documentation of livedoid vasculopathy.\n4. History of triple positive aPL within the prior 5 years and at least 12 weeks prior to enrollment, including all of the following:\n\n   1. aCL IgG level \\> Upper Limit of Normal (ULN), and\n   2. aβ2GPI IgG level \\> ULN, and\n   3. Positive LA test.\n5. Confirmation of triple positive aPL at screening, including all of the following:\n\n   1. aCL IgG level ≥ 40 GPL, and\n   2. aβ2GPI IgG level ≥ 40 SGU, and\n   3. Positive LA test.\n6. Undergoing anticoagulation with warfarin or low molecular weight heparin (LMWH), if there is a history of arterial or venous thrombosis.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to give written informed consent.\n2. Inability or unwillingness to comply with study protocol.\n3. Systemic autoimmune diseases other than APS, including but not limited to:\n\n   1. Systemic lupus erythematosus (SLE) meeting the EULAR\u002FACR classification criteria.\n   2. Rheumatoid arthritis meeting the ACR\u002FEULAR classification criteria.\n   3. Small, medium, and large vessel vasculitis meeting ACR classification criteria.\n4. Catastrophic APS classification within the prior 90 days.\n5. Acute arterial or venous thrombosis within the prior 30 days.\n6. Use of the following medications:\n\n   1. Any prior treatment with CD38 targeting monoclonal antibodies, including daratumumab or isatuximab-irfc.\n   2. The following within the prior 30 days:\n\n   i. Corticosteroids \\> 10 mg\u002Fday prednisone or equivalent. ii. Direct oral anticoagulants (DOACs). iii. Live attenuated vaccines. iv. IVIG or other supplemental immunoglobulin. c. Azathioprine, methotrexate, mycophenolate mofetil, mycophenolate sodium, lefluonomide, or calcineurin inhibitors within the prior 90 days.\n\n   d. Cyclophosphamide within the prior 90 days. e. Immunomodulatory or immunosuppressive biologic agents, including belimumab, within the prior 90 days or 5 half-lives, whichever is greater.\n\n   f. Investigational agents within the prior 90 days or 5 half-lives, whichever is greater, except for COVID-19 vaccines and medications for prevention or treatment of COVID-19 per FDA Emergency Use Authorization (EUA).\n\n   g. Biologic B cell depleting agents including rituximab with any of the following: i. Treatment within the prior 180 days, or ii. CD19+ absolute count \\\u003C 40\u002F μl, or iii. Serum IgG \\\u003C500 mg\u002FdL.\n7. Plasma exchange within the prior 90 days.\n8. Hemodialysis within the prior 90 days.\n9. Major surgical procedure within the prior 60 days.\n10. Known allergy, hypersensitivity, or intolerance to boron, malitol, sorbitol, corticosteroids, monoclonal antibodies including daratumumab, human proteins, or their excipients.\n11. Allergy, intolerance, or contraindication to acyclovir, valacyclovir, and famciclovir.\n12. Active or chronic infection, including the following:\n\n    1. Active bacterial, viral, fungal, or opportunistic infection.\n    2. Chronic infection requiring suppressive antibiotic treatment.\n    3. Intravenous antibiotics or hospitalization for infection within the prior 30 days.\n    4. Evidence of current or prior Mycobacterium tuberculosis infection.\n    5. Human immunodeficiency virus (HIV).\n    6. Current or prior infection with hepatitis B virus (HBV).\n    7. Current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response ≥ 12 weeks.\n    8. History of recurrent herpes zoster, or history of herpes zoster ophthalmicus, disseminated herpes zoster, or disseminated herpes simplex.\n13. The following laboratory abnormalities:\n\n    ITN093AI: DARE-APS Version 3.0 September 12, 2023 Daratumumab in Primary Antiphospholipid Syndrome\n    1. Absolute neutrophil count \\\u003C 1500\u002Fmm3.\n    2. Platelets \\\u003C 100,000\u002Fmm3.\n    3. Hemoglobin (Hgb) \\\u003C 10 g\u002FdL.\n    4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \\> 2x the Upper Limit of Normal (ULN).\n    5. Total bilirubin \\> 2x ULN, except in the case of congenital bilirubinemia then direct bilirubin \\> 2x ULN.\n    6. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73 m2.\n14. History of primary immunodeficiency.\n15. History of solid organ or hematopoietic stem cell transplantation.\n16. Comorbidities requiring systemic corticosteroid therapy, including those which have required three or more courses of systemic corticosteroids within the 12 months prior to Visit 0.\n17. Any of the following conditions with FEV1 \\\u003C 70% predicted within the prior 90 days:\n\n    1. Asthma.\n    2. Chronic obstructive pulmonary disease (COPD).\n    3. DAH.\n18. Pulmonary hypertension.\n19. Adrenal insufficiency.\n20. Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥ 8.0%.\n21. Concomitant malignancy or history of malignancy, except adequately treated or excised nonmetastatic squamous cell carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.\n22. Clinically significant cardiac disease, including but not limited to:\n\n    1. Myocardial infarction within the prior 6 months, or\n    2. Unstable or uncontrolled disease or condition related to or affecting cardiac function, including but not limited to:\n\n    i. Unstable angina, or ii. Congestive heart failure, New York Heart Association Class II-IV, or iii. Uncontrolled cardiac arrhythmia.\n23. Current diagnosed mental illness or current diagnosed or self-reported drug or alcohol abuse which, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.\n24. Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease.\n25. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.\n26. Lack of peripheral venous access.\n27. Pregnancy, or planning a pregnancy during the 48 week study duration.\n28. Breast-feeding.\n29. Unwillingness to use medically acceptable non-prothrombotic contraception if of reproductive potential and engaging in sexual activity that could lead to pregnancy.","65 Years",{"count":115,"type":21},22,[86,24],"The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS).\n\nThree daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) cohort, for a total of up to 22 participants. The dosing cohorts are: 4 mg\u002Fkg, 8 mg\u002Fkg, and 16 mg\u002Fkg. Each cohort will receive intravenous (IV) administration of daratumumab according to the following schedule, for a total of 8 doses.\n\nThe primary objective is to determine the safety of daratumumab in APS defined as Dose Limiting Toxicities (DLTs) occurring during the dose escalation phase.",[27],[120,121],"Daratumumab","Anti-Phospholipid Syndrome","2026-03-27",{"date":124,"type":36},"2026-04-02",{"date":126,"type":36},"2023-05-26",{"date":128,"type":21},"2027-03",{"name":42,"class":43}]