[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-system-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-system-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,90],{"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":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100529082","detection-and-characterization-of-neurologic-manifestations-of-inborn-and-acquired-errors-of-immunity-100529082",false,"NCT06169150","Detection and Characterization of Neurologic Manifestations of Inborn and Acquired Errors of Immunity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged \\>=2 years. To be seen at the NIH CC, participants must be \\>=3 years of age.\n2. Willing to allow specimens and data to be stored for future research.\n3. Willing to allow genetic testing on their biospecimens.\n4. Able to provide informed consent (for ages \\>=18 years) or has parent(s) or guardian(s) who can provide permission to participate on their behalf (for ages \\\u003C18 years).\n\n   * Decisionally impaired affected adult participants may have a legally authorized representative (LAR) to provide informed consent on their behalf.\n\nAdditional Inclusion Criterion for Affected Participants:\n\nHas a primary or acquired immunodeficiency and known or suspected infection or inflammation of the nervous system or post-infection sequelae, based on clinical or imaging data provided by the referral facility, or is at risk of developing such a neurologic complication. For the purpose of this study, neuroinfectious disease or neuroinflammation is defined as any of the following:\n\n1. Any neurologic symptoms accompanied by CSF with evidence of inflammation (which may include pleocytosis, hypoglycorrachia, elevated protein, or other evidence of intrathecal immune activation, including immunoglobulin \\[Ig\\] G index or presence of oligoclonal bands).\n2. Systemic infection or inflammatory disease with neurologic involvement.\n3. Neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI).\n4. Clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation.\n5. History of infection or inflammatory process of the nervous system.\n\nAffected participants must also have their own primary health care provider to manage their condition outside the NIH.\n\nAdditional Inclusion Criteria for Biological Relatives and Healthy Volunteers:\n\n1. Is either a biological relative of an affected participant or is unrelated.\n2. Does not have a known diagnosis of neuroinfectious disease or neuroinflammation.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnant (for biological relatives and healthy volunteers).\n2. Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.",true,"ALL","2 Years","120 Years",{"count":20,"type":21},350,"ESTIMATED","OBSERVATIONAL","Background:\n\nImmune system and nervous system have significant interaction so that People with immunity diseases can have complications that affect the nervous system and people with some neurological disease may have defects in their immune system.These complications can affect many body functions, including how they move, walk, think, and feel. Researchers do not fully understand how immune diseases affect the nervous system. By learning more, they hope to create more effective treatments.\n\nObjective:\n\nTo learn more about the interaction between immune and nervous system and how immunity disease affect the nervous system.\n\nEligibility:\n\nPeople aged 2 years and older with an immunity disease. Their healthy biological relatives and other healthy volunteers are also needed.\n\nDesign:\n\nParticipants will be screened. Blood will be drawn for research. They may have imaging scans. Adults may undergo lumbar puncture: A needle will be inserted into their back to collect fluid from the space around the spinal cord. The imaging scans and lumbar puncture will be optional for healthy relatives and volunteers.\n\nAll participants will have 1 study visit per year for 5 years.\n\nThey will be asked to donate samples of body fluids at each visit. Blood samples are required for the study. All other donations are optional. These may include saliva, urine, breast milk, stool, vaginal secretions, and wound drainage.\n\nAffected participants may be asked for a skin biopsy: A small sample of skin will be removed. They may also be photographed or videotaped to record the symptoms of their disease.\n\nTests for each study visit may be spread over several days, if needed.\n\nVisits may be at the clinic. Participants may also collect their own samples at home and send them to the researchers....",[25,26],"Nervous System Disease","Immune System Disease",[28,29,30,31,32,33,34,35],"Errors Of Immunity","Neurological Diseases","Neuroinflammation","Neuroinfections","Neurodegeneration","Primary Immunodeficiency","Neuropathogenesis","Inborn Errors of Immunity","RECRUITING","2026-08-04",{"date":39,"type":40},"2026-08-05","ACTUAL",{"date":42,"type":40},"2024-01-12",{"date":44,"type":21},"2043-10-01",{"name":46,"class":47},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":15,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":48},"100649624","phase-1-a-study-of-hl40626s-tablets-in-healthy-adults-100649624","NCT07736586","A Study of HL40626S Tablets in Healthy Adults","A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, 2-Part, Phase Ι Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HL40626S Tablets Following Oral Administration of Single and Multiple Ascending Doses to Healthy Adult Participants.","Inclusion Criteria:\n\n1. Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.\n2. Between the ages of 18.0 and 55.0 years (inclusive) at the time of Screening.\n3. BMI between 18.0 and 32.0 kg\u002Fm2 (inclusive) at the time of Screening, with a body weight ≥ 50 kg.\n4. In good general health, as determined by the Investigator.\n5. Female participants must be non-pregnant and non-lactating.\n6. Female participants must be of non-childbearing potential, or agree to use dual contraception methods (female participants exclusively in same-sex relationships are exempt from the above contraception requirements), and abstain from ova (egg) donation throughout the entire duration of the study and for at least 90 days after the last dose, and have negative pregnancy test results at Screening (serum) and Day -1 (urine). (Note: As this is a first-in-human \\[FIH\\] study, the applicable t₁\u002F₂ and corresponding restriction period may be adjusted based on emerging PK data).\n7. Male participants with female partners of reproductive potential must agree to practice complete abstinence or to use a condom (male participant) plus an additional highly effective method (female partner) of contraception for the duration of the study and for at least 90 days after last dosing (Male participants exclusively in same-sex relationships are exempt from the above contraception requirements); all male participants must also agree to refrain from sperm donation for at least 90 days after the last dose. (Note: As this is a FIH study, the applicable t₁\u002F₂ and corresponding restriction period will be adjusted based on real-time PK data).\n\nExclusion Criteria:\n\n1. Clinically significant abnormal medical history, such as gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, drug hypersensitivity, as determined by the Investigator, any abnormal findings on physical examination, VS measurements, ECG or laboratory tests at Screening, Admission or pre dose on Day 1 that, in the opinion of the Investigator, could jeopardize achieving the study objectives and\u002For compromise the participant's safety.\n2. Any of the following ECG findings at Screening, Admission and\u002For pre dose on Day 1:\n\n   1. Any out-of-range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator.\n   2. Any ECG finding that, in the opinion of the Investigator, may compromise interpretation of ECG for cardiac safety assessments and\u002For complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities).\n   3. Participants with QTcF \\>450 msec (if male) or \\>470 msec (if female) will be excluded.\n3. Resting HR \\\u003C 40 bpm or \\>100 bpm when vital signs are measured at Screening\n4. SARS-CoV-2 positive by PCR at Admission regardless of symptoms.\n5. Unstable cardiovascular disease, including recent (within 6 months of screening) myocardial infarction or cardiac arrhythmia.\n6. Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as ALT, AST, gamma glutamyltransferase (GGT), alkaline phosphatase (ALP) or total\u002Fdirect bilirubin \\> upper limit of the reference range (ULRR) at Screening or Admission. Participants with confirmed Gilbert's syndrome will not be permitted to enroll in the study.\n7. Indications of pre-metabolic syndrome and\u002For systemic inflammation, as suggested by high-sensitivity C-reactive protein (hsCRP) of \\> 3 mg\u002FL, elevated erythrocyte sedimentation rate (Male ≥ 15 mm\u002Fhr, Female ≥ 20 mm\u002Fhr) or Hemoglobin A1c (HbA1c) \\>5.3% at Screening.\n8. History of cancer (malignancy) with the exception of basal or squamous cell carcinoma of the skin.\n9. Respiratory tract infection (upper and\u002For lower) treated with antibiotics within 12 weeks of Screening.\n10. Clinically significant infection or known inflammatory condition or history of clinically significant infection within 28 days prior to study drug administration on Day 1 that, in the opinion of the Investigator, would affect the participant's ability to participate in the trial.\n11. History of drug or alcohol abuse (as defined by DSM-V) within 12 months prior to Screening.\n12. Positive test result for alcohol (breath) or drugs of abuse (urine) at Screening or Admission.\n13. Positive serology result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.\n14. Active or recent herpes simplex or herpes zoster infection, if considered clinically relevant as per investigator discretion.\n15. Venous access considered inadequate for PK sample collection; history of evidence of adverse symptoms associated with phlebotomy or blood donation.\n16. Participation in a study of any investigational drug, device, biologic or other agent within 30 days (or 5 half-lives, whichever is longer \\[as applicable\\]) prior to Day 1.\n17. Loss or donation of blood \\>500 mL (within 30 days prior to Screening); donation of bone marrow or peripheral stem cells (within 90 days prior to Day 1); or donation of plasma (within 7 days prior to Screening).\n18. No more than 10 standard drinks per week per NHMRC alcohol guidelines within 90 days prior to screening.\n19. Use of alcohol within 72 hours prior to study drug administration on Day 1.\n20. Use of prescription drugs within 14 days (or 5 half-lives, whichever is longer), or non-prescription drugs and\u002For herbal supplements within 7 days (or 5 half-lives, whichever is longer) prior to study drug administration on Day 1. Exception: hormonal contraceptives, acetaminophen ≤ 1 gram\u002Fday or ibuprofen ≤ 800 mg\u002Fday may be administered at Investigator's discretion.","18 Years","55 Years",{"count":59,"type":21},64,"INTERVENTIONAL",[62],"PHASE1","This is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.",[65,66,26,67],"Psoriasis (PsO)","Skin Disease","Skin Diseases, Papulosquamous",[69,70,71,72,73,74,75,76,77,78],"Phase 1","Healthy Participants","HL40626S","Oral Tablets","SAD","MAD","Safety","Pharmacokinetics","Immunogenicity","Pharmacodynamics","NOT_YET_RECRUITING","2026-07-31",{"date":82,"type":40},"2026-08-03",{"date":84,"type":21},"2026-08",{"date":86,"type":21},"2027-05",{"name":88,"class":89},"HighsLab Therapeutics Inc.","INDUSTRY",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":60,"phases":100,"briefSummary":101,"conditions":102,"keywords":116,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100598722","phase-1-a-study-to-evaluate-a-novel-gene-therapy-in-patients-with-relapsed-and-refractory-multiple-myeloma-100598722","NCT07075185","A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma","inMMyCAR","Inclusion Criteria:\n\n* Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease\n* Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody\n* Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1\n* Participants must have acceptable laboratory values as defined by the protocol\n\nExclusion Criteria:\n\n* Participants must not have known central nervous system (CNS) involvement with myeloma\n* Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis\n* Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy\n* Participants cannot require systemic steroids for any condition",{"count":99,"type":21},70,[62],"The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.",[103,104,105,106,107,108,109,110,111,112,113,114,26,115],"Multiple Myeloma in Relapse","Myeloma Multiple","Multiple Myeloma Progression","Neoplasms by Histologic Type","Neoplasm","Hemostatic Disorders","Vascular Disorder","Paraproteinemias","Blood Protein Disorders","Hematologic Disease and Disorders","Lymphoproliferative Disorders","Immunoproliferative Disorders","Gene Therapy",[117,118,119,120],"in vivo CAR-T","multiple myeloma","gene therapy","BMCA","2026-07-06",{"date":123,"type":40},"2026-07-08",{"date":125,"type":40},"2025-07-16",{"date":127,"type":21},"2042-05",{"name":129,"class":89},"Kelonia Therapeutics, Inc.",10]