[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antibody-mediated-rejection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antibody-mediated-rejection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,65,101,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100651792","phase-2-study-of-sg301-for-renal-amr-after-transplantation-100651792",false,"NCT07764627","Study of SG301 for Renal AMR After Transplantation","A Phase II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG301 Injection in Patients With Antibody-Mediated Rejection (AMR) After Renal Transplantation","Inclusion Criteria:\n\n1. Voluntarily sign the written informed consent form;\n2. Age ≥18 and ≤75 years;\n3. Expected survival ≥3 months;\n4. ≥180 days after renal transplantation, with stable graft function (from living or deceased donor);\n5. Biopsy-confirmed active or chronic active AMR (with or without peritubular capillary C4d deposition), per Banff 2022 classification;\n6. DSA: within 6 months prior to first dose, donor specific antibodies (DSA) specific to HLA class I and\u002For II antigens (pre existing and\u002For de novo) confirmed by local laboratory and meeting the local laboratory's positive definition;\n7. Estimated glomerular filtration rate (eGFR) ≥20 mL\u002Fmin\u002F1.73 m² at screening (CKD EPI formula);\n8. Recovery from adverse events due to prior treatment to ≤ Grade 1 (CTCAE v6.0), except for toxicities such as alopecia that are judged by the investigator to have no safety risk and not to violate other inclusion\u002Fexclusion criteria;\n9. Female participants of childbearing potential or male participants whose partners are of childbearing potential must remain abstinent or use reliable contraceptive measures during the study treatment period and for at least 6 months after the last dose of SG301. Male participants must refrain from sperm donation during the study and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Concomitant T cell-mediated rejection (TCMR);\n2. New-onset or recurrent severe thrombotic microangiopathy; polyomavirus nephropathy; new-onset or recurrent glomerulonephritis;\n3. Prior treatment with other anti-CD38 monoclonal antibodies;\n4. Use of other monoclonal\u002Fpolyclonal antibody immunosuppressive agents within 3 months prior to the first dose of study drug;\n5. Latent or active tuberculosis, or active viral (HBV, HCV, HIV, CMV), bacterial, or fungal infection requiring systemic therapy, or other active infections requiring systemic treatment;\n6. Active malignancy that makes the patient unsuitable for immunosuppressive therapy;\n7. Presence of serious medical or psychiatric illness that may interfere with the smooth conduct of the study;\n8. Prior multi-organ transplantation (including en bloc or dual kidney transplantation);\n9. Acute, rapid decline in renal function such that, in the investigator's judgement, the participant is likely to require renal replacement therapy within the subsequent 30 days;\n10. Receipt of any of the following treatments for AMR or TCMR within 3 months prior to the first dose of study drug (with the exception of glucocorticoids):\n\n    1. Intravenous or subcutaneous immunoglobulin (IVIg\u002FSCIg), plasma exchange, or immunoadsorption (antibody-depleting therapies);\n    2. Complement system inhibitors (e.g., eculizumab);\n    3. Proteasome inhibitors (e.g., bortezomib);\n    4. Tocilizumab;\n    5. Other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to start of study treatment;\n11. Female participants who are pregnant or breastfeeding;\n12. Other conditions that, in the investigator's judgement, would make the participant unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the safety and tolerability of SG301 injection in patients with antibody-mediated rejection (AMR) after renal transplantation.",[27],"Antibody Mediated Rejection","NOT_YET_RECRUITING","2026-08-13",{"date":31,"type":32},"2026-08-17","ACTUAL",{"date":34,"type":21},"2026-09-01",{"date":36,"type":21},"2028-06-30",{"name":38,"class":39},"Hangzhou Sumgen Biotech Co., Ltd.","INDUSTRY",7,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100642473","phase-1-a-two-part-dose-escalation-safety-and-efficacy-study-of-cid-103-in-adults-with-active-and-chronic-active-renal-allograft-antibody-mediated-rejection-abmr-100642473","NCT07641426","A Two Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection (ABMR).","A 2 Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection.","Inclusion Criteria:\n\n1. At least 18 years old at time of signing of ICF.\n2. Voluntary, written, informed consent prior to study-specific procedures.\n3. Functioning living or deceased donor renal allograft ≥ 180 days post-transplant.\n4. eGFR ≥ 25 mL\u002Fmin\u002F1.73 m2 chronic kidney disease epidemiology collaboration (CKD-EPI 2021, see APPENDIX A).\n5. HLA class I and\u002For II antigen-specific antibodies (preformed and\u002For dnDSA).\n6. Existing diagnosis of active or chronic\u002Factive ABMR (± C4d in peritubular capillaries) within the last 180 days according to the Banff 2022 classification as per local pathology read.\n7. Must have a renal biopsy within 28 days (preferably within 14 days) of first study drug administration for central pathology review. Results of the central pathology review are not required prior to first study drug administration.\n8. Participants who have been diagnosed with pre-existing HLA class I\u002FII DSA at the time of their original renal allograft transplant must have received prior treatment with intravenous immune globulin (IVIG) and plasmapheresis (unless contraindicated).\n9. Participants with active ABMR may have received prior treatment with IVIG and plasmapheresis (not required).\n10. For participants that have received prior IVIG, subcutaneous immunoglobulin (SCIg), plasmapheresis, complement system inhibitors (e.g., eculizumab), proteasome inhibitors (e.g., bortezomib) or an interleukin-6 inhibitor (e.g. tocilizumab), or an anti-CD20 (e.g., rituximab) a washout period ≥12 weeks is required prior to first study drug administration\n11. Standardized immune suppression regimen.\n12. Adequate organ function without transfusions, within 14 days of first dose of study drug.\n13. Contraception.\n\nExclusion Criteria:\n\n1. ABO-incompatible transplant.\n2. Any of the following on baseline biopsy:\n\n   1. T-cell-mediated rejection classified Banff Grade ≥ 1.\n   2. de novo or recurrent severe thrombotic microangiopathy.\n   3. polyoma virus nephropathy.\n   4. de novo or recurrent glomerulonephritis.\n3. Acute rejection treatment within 180 days of dosing.\n4. Contraindication to repeat biopsies.\n5. Previous treatment with other anti-CD38 monoclonal antibodies.\n6. Other immunomodulatory antibodies within ≤ 90 days of dosing.\n7. Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of study drug or five half-lives (if shorter).\n8. Participants unable to modify baseline immune suppression.\n9. Active viral, bacterial, or fungal infection precluding intensified immunosuppression.\n10. Known latent or active tuberculosis.\n11. Known active infection with human immunodeficiency virus (HIV).\n12. Known active infection.\n13. IgG \\\u003C 400 mg\u002FdL.\n14. Other chronic or acute disease(s) likely to interfere with study endpoint evaluation.\n15. Active malignant disease or premalignant condition within two years, precluding intensified immunosuppressive therapy.\n16. Administration of a live vaccine ≤ 6 weeks of screening.\n17. Participation in interventional component of another clinical trial.\n18. History or clinical evidence of any surgical or medical condition which the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, particularly any pre-existing condition that would put the participant at additional risk should they experience an IRR.\n19. Any unresolved treatment-related AE(s) from prior treatment that have not resolved to Grade 1 or baseline value prior to first dose of study drug.\n20. Known hypersensitivity to CID-103 excipients or prior severe hypersensitivity to a monoclonal antibody.\n21. Participants who experienced a Grade 3 or 4 AE related to prior administration of monoclonal antibodies, which the Investigator feels may recur and\u002For put the participant at significant risk, should be excluded.\n22. Previous Grade 4 anaphylactic reaction to other therapeutic proteins.\n23. Chronic dependence on transfusions or hematopoietic growth factors to maintain acceptable blood counts excluding those participants who require ESAs for documented erythropoietin deficiency. Participants cannot have had a transfusion within the past 14 days prior to first dose of study drug or have had more than 1 transfusion in the past month.\n24. Inability to perform study baseline red blood cell (RBC) type and crossmatch, phenotype (and genotype, if applicable) or lack of available baseline data on RBC phenotype (or genotype, if applicable).\n25. Unable or not willing to agree to the evaluation of RBC antigens by phenotyping or genotyping.\n26. Unable or not willing to comply with the protocol and the visit schedule restrictions and assessments therein.",{"count":49,"type":21},58,[51,24],"PHASE1","The goal of the global Phase 1\u002F2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with with active and chronic active renal allograft antibody mediated rejection (ABMR). The main questions the study aims to answer are:• To evaluate the safety and tolerability of CID-103 in subjects with ABMR with different increasing doses of CID-103.• To evaluate clinical efficacy of CID-103 at an optimal dose in participants with active and chronic active ABMR following renal allograft transplant. The study will be done in two parts: Part A will test increasing doses of CID-103 to see how safe it is and how well people tolerate it. Researchers will also aim to find a safe dose range. Part B will enroll approximately 40 participants to see how well the medicine works and gather more safety and efficacy information. The goal is to find the optimal dose to use in future studies.CID-103 is given through an intravenous (IV) infusion. During the study, participants may receive treatment for up to 12 months, followed by a post-treatment safety follow-up period to check for ongoing safety and effectiveness. This study is an important step toward developing a new treatment for people living with ABMR. If CID-103 is found to be safe and effective, it could offer a new option for patients who do not respond well to current therapies.",[27],"RECRUITING","2026-07-20",{"date":57,"type":32},"2026-07-22",{"date":59,"type":32},"2026-06-09",{"date":61,"type":21},"2030-12",{"name":63,"class":39},"CASI pharmaceuticals, Inc.",4,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100648104","cd38-mab-induction--azathioprine-maintenance-for-chronic-active-amr-in-kidney-transplant-recipients-100648104","NCT07718308","CD38 mAb Induction + Azathioprine Maintenance for Chronic Active AMR in Kidney Transplant Recipients","A Multicenter Exploratory Clinical Study of Targeted NK Cell Inhibition for Transplant Kidney Chronic Active Antibody-Mediated Rejection (caABMR): Single Induction With CD38 Monoclonal Antibody Followed by Sequential Maintenance With Azathioprine","CAZA","Inclusion Criteria:\n\n1. Voluntary written informed consent.\n2. Age ≥18 years.\n3. Kidney transplant (living or deceased donor) ≥180 days prior.\n4. eGFR ≥30 mL\u002Fmin\u002F1.73 m² (CKD-EPI 2021).\n5. Currently on stable triple immunosuppression (CNI + MMF + steroid) for ≥4 weeks, no severe related adverse effects.\n6. Positive HLA Class I and\u002For Class II donor-specific antibodies (DSA).\n7. Transplant kidney biopsy meeting Banff 2022 criteria for chronic active antibody-mediated rejection (caABMR).\n8. TPMT\u002FNUDT15 genotyping: non-homozygous mutant (normal or intermediate metabolizer).\n\nExclusion Criteria:\n\n1. Participating in another clinical trial.\n2. Age \\\u003C18 years.\n3. Pregnant, breastfeeding, or inadequate contraception in females.\n4. ABO-incompatible transplant.\n5. TPMT\u002FNUDT15 homozygous mutant genotype.\n6. Biopsy shows any of: T-cell mediated rejection (TCMR), new\u002Frecurrent severe thrombotic microangiopathy, or polyomavirus nephropathy.\n7. Received anti-rejection therapy in prior 3 months.\n8. Received other immunomodulatory monoclonal\u002Fpolyclonal antibodies (anti-CD20, bortezomib, anti-C5, anti-IL-6\u002FIL-6R) in prior 3 months.\n9. Total bilirubin \\>2×ULN or ALT\u002FAST \\>2.5×ULN.\n10. Hemoglobin \\\u003C8 g\u002FdL.\n11. Platelets \\\u003C100×10\\^9\u002FL.\n12. WBC \\\u003C3×10\\^9\u002FL or neutrophils \\\u003C1.5×10\\^9\u002FL.\n13. Hypogammaglobulinemia: IgG \\\u003C400 mg\u002FdL.\n14. Active bacterial, viral, or fungal infection.\n15. Active malignancy requiring intensified immunosuppression.\n16. Latent or active tuberculosis.\n17. Live vaccine within 6 weeks of screening.\n18. History of alcohol or illicit drug abuse.\n19. Severe medical or psychiatric illness likely to impair study participation.\n20. Active hepatitis B.\n21. Known hypersensitivity to CD38 mAb, azathioprine, or study drug components, or severe drug allergy history.",{"count":74,"type":21},20,[76],"NA","This multicenter, prospective, single-arm exploratory study evaluates the efficacy and safety of a novel sequential regimen for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients: single-dose CD38 monoclonal antibody (1800 mg subcutaneous) induction to deplete plasma cells and NK cells, followed by long-term maintenance with azathioprine (replacing mycophenolate mofetil) plus standard triple immunosuppression (steroid + calcineurin inhibitor). The regimen aims to control DSA-driven injury, stabilize or improve graft function (primary: eGFR decline slope), reduce DSA, improve pathology (Banff 2022), and minimize infection\u002Fnephrotoxicity risks associated with intensified or prolonged biologic therapy. Twenty patients across 6 Chinese transplant centers will be enrolled. CD38 mAb, azathioprine, key monitoring tests (HLA antibody, pharmacogenomics, immune profiling) are provided free by the study team (\\~40,000 RMB per patient). Ethics approved; informed consent obtained.",[79,80],"Kidney Transplantation","Antibody-mediated Rejection",[82,83,84,85,86,87,88,89,90],"Daratumumab","Banff 2022 classification","Azathioprine","Natural killer cell","Donor specific antibody","eGFR slope","Chronic active AMR","CD38 antibody","Sequential immunosuppression","2026-07-16",{"date":93,"type":32},"2026-07-21",{"date":95,"type":21},"2026-07-15",{"date":97,"type":21},"2028-03-15",{"name":99,"class":100},"wujianyong","OTHER",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":112,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100439607","biorepository-and-registry-for-plasma-exchange-patients-100439607","NCT05004493","Biorepository and Registry for Plasma Exchange Patients","Assessment of Changes in Normal and Pathological Immune Factors in Patients Undergoing Plasma Exchange","Pts undergoing plasma exchange therapy are eligible to be in this protocol","12 Years","99 Years",{"count":111,"type":21},200,"1 Year","OBSERVATIONAL","Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered within the standard of care for these patients and are covered by insurance. This study will not influence the treatment plan for subjects who participate in this study. The goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, PBMCs) for current and future studies. Any patient undergoing plasma exchange procedures will be eligible for the study. Patients or the legally authorized representative (LAR) will be consented for the study as soon as feasible after the are referred to DeGowin for plasma exchange. The immediate objective of the study is to examine antibody levels (IgG\u002FIgM) and BAFF levels in the blood of these patients over the course of the plasma exchange treatments. Specimens and clinical data will be collected such that other immune factors that may regulate B cell survival, proliferation and antibody secretion can be studied. Another goal of the study is to isolate and cryopreserve PBMCs at different points during the patient's treatment. This would allow the study of immune cells that may mediate these diseases. The study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. The collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.",[80,116,117,118],"NMO Spectrum Disorder","TTP","CIDP",[120,121],"plasma exchange","plasmapheresis","2025-05-15",{"date":124,"type":32},"2025-05-20",{"date":126,"type":32},"2021-07-28",{"date":128,"type":21},"2040-12-31",{"name":130,"class":100},"Charles M Knudson",1,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":40},"100524762","a-prospective-randomized-trial-of-ecp-in-subclinical-amr-100524762","NCT06112951","A Prospective Randomized Trial of ECP in Subclinical AMR","The Use of Extracorporeal Photopheresis as Immunomodulatory Therapy of Subclinical Antibody-mediated Rejection After Lung Transplantation: a Prospective RCT","EUROEXPORT-DSA","Inclusion Criteria:\n\n* Bilateral lung transplantation\n* dnDSAs \\> 3 months with a MFI \\> 1000\n* No signs of allograft dysfunction\n* Alemtuzumab induction therapy\n\nExclusion Criteria:\n\n* Inclusion in other studies\n* Retransplantation\n* Multi-organ transplantation\n* \\> 12 months after transplantation",{"count":141,"type":21},80,[76],"The goal of this clinical trial is to evaluate the therapeutic effect of extracorporeal photopheresis in subclinical antibody-mediated rejection after lung transplantation.The main questions it aims to answer are:\n\n1. Does ECP therapy result in a significant reduction in MFI (Mean Fluorescence Intensity) from the baseline MFI in clinically stable patients with persistent (\\>6 months) dnDSAs (MFI\\>1000)?\n2. What is the impact of ECP therapy on the following outcomes in these patients: ACR, clinical AMR, CLAD, infections, drop-out rate, survival, adverse events?\n\nParticipants will be randomized into two groups. Each group will include 40 patients. The control group will be observed and no active treatment will be administered. The treatment group will receive extracorporeal photopheresis. First, a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.\n\nResearchers will compare the two groups regarding: MFI value, development of ACR, clinical AMR, CLAD, infections, survival, adverse events, immunophenotyping, miRNA expression profiling, cytokine expression, gene expression signature of PBMCs and proteomic characterization.",[80,145],"Lung Transplant Rejection","2024-07-08",{"date":148,"type":32},"2024-07-09",{"date":150,"type":32},"2024-03-01",{"date":152,"type":21},"2027-06-01",{"name":154,"class":100},"Medical University of Vienna"]