[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Quan Dong Nguyen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100625822","phase-1-a-proof-of-concept-trial-to-evaluate-the-efficacy-and-safety-of-cell-therapy-trx103-in-patients-with-active-non-infectious-uveitis-100625822",false,"NCT07427628","A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis","A Proof-of-Concept Trial to EvaluAte the EfficaCy and Safety Of Cell Therapy TRX103 Administered Intravenously in Patients With Active, Non-infectious Intermediate, Posterior, and Pan-Uveitis - PEACOCX Study","PEACOCX","Inclusion Criteria:\n\n1. ≥ 18 to ≤ 70 years of age at time of consent.\n2. Weight of ≥ 40 kg at time of consent.\n3. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.\n4. Diagnosis of active non-infectious uveitis (NIU); intermediate, posterior, or panuveitis at screening as defined as having at least ONE of the following findings:\n\n   1. .≥ 2+ VH (NEI\u002FSUN Scale) OR\n   2. Active inflammatory chorioretinal or inflammatory retinal lesion or lesions as defined by fluorescein angiography (FA) or optical coherence tomography (OCT).\n5. Subjects on treatment with corticosteroids may be included if they meet the following:\n\n   1. Prednisone ≤ 20 mg\u002Fday; or an equivalent dose of another corticosteroid\n   2. Have been on a stable dose for at least 7 days prior to TRX103 dose.\n   3. No ongoing treatment with a systemic non-corticosteroid, biologic, small molecules or immunomodulatory agent.\n6. If the patient is on specific therapies such as systemic non-corticosteroid biologic agents, immunomodulatory agents or small molecules etc., appropriate washout periods defined in the protocol must be met prior to infusion at Day 0.\n\nExclusion Criteria:\n\n1. Any condition preventing evaluation\u002Fassessment of both eyes.\n2. Any significant ocular disease that could compromise vision.\n3. Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to non-uveitis causes.\n4. Isolated anterior uveitis.\n5. Macular edema as the only sign of uveitis, defined on OCT without active anterior\u002Fposterior inflammatory signs.\n6. Age-related macular degeneration or serpiginous choroidopathy.\n7. Myopic degeneration with active sub-foveal choroidal neovascularization.\n8. Confirmed or suspected current infectious uveitis.\n9. Has ocular masquerade syndrome, like ocular lymphoma.\n10. Any of the following ongoing treatments or anticipated use of any of the following treatments prior to TRX103 dose, for the time periods specified below:\n\n    1. Systemic immunosuppressants or immunomodulatory drugs within 4 weeks\n    2. Small molecules, e.g., JAK inhibitors or TYK2 inhibitors within 4 weeks\n    3. Anti-vascular endothelial growth factor (anti-VEGF) therapy within 8 weeks\n    4. TNF inhibitor therapy within 8 weeks\n    5. Agents that modulate T cells within 3 months\n    6. IL-6 inhibitors within 8 weeks\n    7. Therapeutic agents targeted to IL-17 within 4 months\n    8. Agents that modulate B cells within 6 months\n    9. Therapeutic agents targeted to IL-12 or IL-23 within 6 months\n11. Has received intraocular or periocular (including subtenon, intracanalicular) corticosteroids within 8 weeks prior to TRX103 dose, unless otherwise specified below:\n\n    1. Retisert® or Yutiq® (glucocorticosteroid implants) within 3 years prior or has had complications related to the implant;\n    2. Retisert® (glucocorticosteroid implant) removed within 3 months prior or has had complications related to device removal;\n    3. Ozurdex® (dexamethasone implant) or Xipere™ (suprachoroidal triamcinolone) within 4 months prior.\n12. Ocular surgery within 90 days prior to TRX103 dose in the study eye, including glaucoma surgery (trabeculectomy or aqueous shunt device), and vitreoretinal surgery. Nd: YAG capsulotomy within 30 days prior to TRX103 dose in the study eye is also an exclusion criterion.\n13. Any of the following cardiovascular risk factors:\n\n    1. History of NYHA Class III or IV criteria cardiac insufficiency\n    2. Clinically significant cardiac dysrhythmia\n    3. QTcF \\> 450 msec (male) or \\> 470 msec for (female)\n    4. Unstable angina in last 3 months;\n    5. Myocardial infarction within past year\n    6. CABG surgery past year.\n14. Impaired kidney function, defined as any of the following:\n\n    1. Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula or as measured by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) equation \\\u003C 40 mL\u002Fmin\u002F1.73 m2\n    2. Proteinuria, defined as urine protein\u002Fcreatinine ratio \\> 25\n    3. Symptomatic nephrolithiasis within 6 months of screening.\n15. Subjects who are breastfeeding, pregnant, or planning to become pregnant, or subjects of childbearing potential who are unwilling to apply a highly effective birth control method prior to TRX103 dose.\n16. Anaphylaxis to fluorescein or unwillingness to undergo fluorescein angiograms.\n17. Live vaccine within 6 weeks prior to Day 0 (day of infusion) or expected to need a live vaccine during the study.\n18. Active bacterial, viral, fungal, mycobacterial, or other infections that would require treatment. Active infections must be resolved prior to enrollment.\n19. Have required management of infections as follows:\n\n    1. Currently on suppressive therapy for any chronic infection\n    2. Hospitalization for infection within past 60 days\n    3. Use of IV or IM antibacterials, antivirals, antifungals, or anti- parasitic agents within past 60 days\n    4. History of disseminated herpes zoster, history of or invasive HSV, or recurrent (≥ 2 episodes within last 5 years) localized herpes zoster\n    5. Infection with Mycobacterium tuberculosis (TB).\n    6. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.\n    7. Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).\n    8. Positive serology for HIV.\n    9. Lab test results indicating active syphilis infection.\n20. History of significant trauma or major surgery within 4 weeks prior to TRX103 dose or scheduled to undergo major surgery during the study.\n21. History of blood transfusion within the last 3 years.\n22. Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant.\n23. Received another investigational agent or therapy, within 28 days of planned TRX103 infusion (or 5 half-lives, whichever is longer) and\u002For have not recovered from treatment related toxicities.\n24. Screening laboratory and other analyses show any of the following abnormal results:\n\n    1. Serum aspartate transaminase or alanine transaminase \\> 3.0 × upper limit of normal;\n    2. Bilirubin ≥ 2 x ULN;\n    3. Total white blood cell count \\\u003C 2,000\u002FμL;\n    4. Hemoglobin \\\u003C 8 g\u002FdL;\n    5. Platelet count \\\u003C 100,000\u002FμL;\n    6. Absolute neutrophil count \\\u003C 1,200\u002FμL;\n    7. Absolute lymphocytes count \\\u003C 750\u002FμL.\n25. Subjects with a history of any other significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support such dysfunction.\n26. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results, which, in the Investigator's opinion:\n\n    1. Places the subject at increased risk during participation in the study, and\u002For;\n    2. Interferes with the subject's capacity to provide informed consent and their participation in the study, and\u002For; interferes with the interpretation of the results.\n27. Participation in any other clinical trial\u002F or receiving any other investigational treatment while enrolled in this study.","ALL","18 Years","70 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this Phase 1, first in uveitis open-label study is to assess the safety and tolerability of TRX-103 in patients with non infectious uveitis (NIU). It is anticipated that up to 18 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time.",[28],"Non Infectious Uveitis",[30,31,32,33,34],"Uveitis","NIU","Cell Therapy","Treg","TRX103","NOT_YET_RECRUITING","2026-02-20",{"date":38,"type":39},"2026-02-23","ACTUAL",{"date":41,"type":22},"2026-03",{"date":43,"type":22},"2028-12",{"name":45,"class":46},"Quan Dong Nguyen","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100528487","phase-1-safety-tolerability-and-distribution-of-laquinimod-eye-drops--the-lion-study-100528487","NCT06161415","Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study","Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study","LION","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Participants who are capable and willing to provide informed consent and follow study instructions.\n3. Participants who are scheduled to undergo pars plana vitrectomy (PPV).\n4. Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye\n5. Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.\n\nExclusion Criteria:\n\n1. Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).\n2. Participants with active infectious uveitis\n3. Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment\n4. Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.\n5. Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment\n6. Use of any topical cyclosporine or corticosteroid or other specified (i.e. calcineurin inhibitors) ophthalmic medication in the study eye for any reason within 14 days of enrollment and before the surgery\n7. Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study).\n8. Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study)\n9. Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)\n10. Moderate or severe renal impairment (GFR ≤60 mL\u002Fmin)\n11. History of HIV disease or other immunodeficiency disorder\n12. History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C\n13. History of organ or bone marrow transplant\n14. Presence of malignancy under active treatment\n15. Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study\n16. Already enrolled in a clinical trial.\n17. Any condition that would prevent the investigator from acquiring images of the eye as required per protocol",{"count":57,"type":22},12,[25],"The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, tolerability, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.",[61,30],"Inflammation",[30,61,63,64,65],"Laquinimod eye drops","Topical","Immunomodulation","RECRUITING","2025-05-12",{"date":69,"type":39},"2025-05-14",{"date":71,"type":39},"2024-05-03",{"date":73,"type":22},"2025-07",{"name":45,"class":46},""]