[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CASI pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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",false,"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.","ALL","18 Years",{"count":19,"type":20},58,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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],"Antibody Mediated Rejection","NOT_YET_RECRUITING","2026-06-06",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":20},"2026-06",{"date":36,"type":20},"2030-12",{"name":38,"class":39},"CASI pharmaceuticals, Inc.","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100594306","phase-1-a-dose-escalation-study-followed-by-a-dose-optimal-study-to-evaluate-the-safety-and-efficacy-of-cid-103-in-adults-with-chronic-immune-thrombocytopenia-100594306","NCT07017725","A Dose-escalation Study Followed by a Dose Optimal Study to Evaluate the Safety and Efficacy of CID-103 in Adults With Chronic Immune Thrombocytopenia","A Dose-escalation and Safety Study of CID-103 Followed by a Randomized, Open-label, Parallel-arm Multi-dose Study Evaluating the Efficacy and Tolerability of CID-103 in Adults With Chronic Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Male or female individuals aged 18 to 65 years at time of signing of ICF. Disease-related.\n2. Diagnosed with ITP that has persisted for ≥ 3 months, diagnosed in accordance with The American Society of Hematology 2019 Guidelines for Immune Thrombocytopenia or the Updated International Consensus Report on the Investigation and Management of Primary Immune Thrombocytopenia (as locally applicable).\n3. Diagnosis of ITP supported by a prior response to an ITP treatment (other than a thrombopoietin receptor agonists \\[TPO-RA\\]) that achieved a platelet count of ≥ 30 x 10\\^9\u002FL and a doubling of baseline measurement.\n4. Has received at least two lines of SOC systemic treatment (i.e., corticosteroids and one other agent).\n5. Has a mean platelet count ≤ 35 x 10\\^9\u002FL on at least two measurements at least one week apart during screening.\n6. If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least four weeks prior to first dose of CID-103.\n7. Adequate organ function.\n8. Contraception: Female participants must either be non-pregnant or not breastfeeding and must have a negative pregnancy test. Male and female participants must meet the contraceptive requirements.\n\nExclusion Criteria:\n\n1. Prior treatment with any anti-CD38 agent, or has been treated with anti-Bruton's tyrosine kinase (BTK), neonatal Fc receptor (FcRn) antagonist or complement inhibitor within three months prior to first dose of CID-103.\n2. Use of IV immunoglobulin, subcutaneous immunoglobulin or anti-D immunoglobulin treatment within four weeks of screening.\n3. Treatment with rituximab or splenectomy within the three months prior to first dose of CID-103.\n4. Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within three weeks before screening.\n5. Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of CID-103 or five half-lives (if shorter).\n6. Active hemolytic anemia.\n7. Diagnosed with severe chronic obstructive pulmonary disease (COPD), Global Initiative for Chronic Obstructive Lung Disease (GOLD Stage 3 or 4) or asthma.\n8. Has been diagnosed with myelodysplastic syndrome or other active malignancy.\n9. Known \u002F clinically significant amyloidosis.\n10. Has a history of any thrombotic or embolic event within six months before screening.\n11. A history or evidence of cardiovascular risk including left ventricular ejection fraction \\\u003C 50%, clinically significant uncontrolled ventricular arrhythmia, acute coronary syndrome history, coronary angioplasty or stenting within six months, current ≥ Class III congestive heart failure (NYHA guidelines), and treatment refractory hypertension.\n12. Clinically significant medical history or ongoing chronic illness.\n13. Known active infection with hepatitis B (HBV) (surface antigen) or infection with hepatitis C (HCV) in absence of sustained virologic response.\n14. History of known or suspected immunosuppression.\n15. Known active infection with human immunodeficiency virus (HIV) and CD4+ T cell count \\\u003C 350\u002FμL.\n16. Karnofsky Performance Status ≤ 70.","65 Years",{"count":50,"type":20},75,[23,24],"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 chronic immune thrombocytopenia (ITP). The main questions the study aims to answer are:\n\n* To evaluate the safety and tolerability of CID-103 in subjects with ITP with different increasing doses of CID-103.\n* To further evaluate the safety and tolerability of CID-103 at two or three dose levels and to select an optimal dose and administration regimen for CID-103 for further study of clinical efficacy.\n\nThe study will be done in two parts:\n\nPart 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.\n\nPart B will compare up to three different doses of CID-103 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.\n\nCID-103 is given through an intravenous (IV) infusion. During the study, participants may receive treatment for up to 6 months, followed by a post-treatment safety follow-up period to check for ongoing safety and effectiveness.\n\nThis study is an important step toward developing a new treatment for people living with chronic ITP. 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.",[54],"Chronic Immune Thrombocytopenia",[56,57,58],"Purpura","Thrombocytopenic","Idiopathic","RECRUITING","2025-06-04",{"date":62,"type":32},"2025-06-12",{"date":64,"type":32},"2025-01-03",{"date":66,"type":20},"2026-12-30",{"name":38,"class":39},6,""]