[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"highly-sensitized-patients-awaiting-kidney-transplant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:highly-sensitized-patients-awaiting-kidney-transplant":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"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":27,"conditions":28,"keywords":35,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100640982","phase-1-immunological-reset-to-enable-access-to-hla-compatible-kidney-transplantation-in-highly-sensitized-patients-reset-100640982",false,"NCT07607197","Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)","Immune Reset to Allow Access to Hla-compatible Kidney Transplantation in Hyperimmunized Patients","HIPER-RESET","Inclusion Criteria:\n\n* Patients aged between 18 and 60 years.\n* Diagnosis of end-stage kidney disease (ESRD) currently maintained on chronic dialysis.\n* Highly sensitized\u002Fhyperimmunized status, defined by a high calculated Panel Reactive Antibody (cPRA) level (e.g., \\>= 95%).\n* Active status on the deceased-donor kidney transplant waiting list.\n* Adequate bone marrow, hepatic, cardiac, and pulmonary function to safely undergo the conditioning regimen and AHSCT.\n* Capable of understanding the study requirements and providing written informed consent.\n\nExclusion Criteria:\n\n* Contraindications to the conditioning regimen medications (rituximab, cyclophosphamide, or rATG).\n* Active, uncontrolled systemic infection, or chronic active infection (including HIV, active Hepatitis B or C, or active tuberculosis).\n* Significant cardiac dysfunction (e.g., Left Ventricular Ejection Fraction \\\u003C 50%) or severe underlying pulmonary disease.\n* History of malignant neoplasm within the past 5 years, excluding successfully treated non-melanoma skin cancer or carcinoma in situ.\n* Previous autologous or allogeneic hematopoietic stem cell transplantation.\n* Pregnancy or breastfeeding.\n* Any psychiatric, medical, or geographical condition that, in the investigator's opinion, prevents compliance with the protocol and long-term follow-up.","ALL","18 Years","60 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney transplant.\n\nPatients who are highly sensitized have developed an extremely high level of antibodies against human leukocyte antigens (HLA), often due to previous transplants, pregnancies, or blood transfusions. This condition makes it nearly impossible for them to find a compatible organ donor, leaving them stuck on dialysis indefinitely.\n\nThis study tests an innovative strategy using Autologous Hematopoietic Stem Cell Transplantation (AHSCT). The procedure involves an intensive conditioning regimen using a combination of medications (cyclophosphamide, thymoglobulin, and rituximab) to deeply clear out the patient's existing mature immune cells. This is followed by the reinfusion of the patient's own previously collected and purified blood stem cells (CD34+ cells) to rebuild the immune system from scratch.\n\nThe investigators hypothesize that this procedure will eliminate the \"immunological memory\" cells responsible for producing the problematic anti-HLA antibodies, resetting the immune system to a \"naive\" or inactive state. This immune reset is expected to eliminate or significantly lower circulating HLA antibodies, creating a critical window of opportunity for these patients to successfully receive a compatible kidney transplant from the deceased-donor waiting list.",[29,30,31,32,33,34],"Kidney Failure, Chronic","Kidney Transplantation","Alloimmunization","HLA Sensitization","End Stage Cronic Kidney Disease","Highly Sensitized Patients Awaiting Kidney Transplant",[36,37,30,38,39,40,41,42,43,44,45],"Autologous Hematopoietic Stem Cell Transplantation","AHSCT","Highly sensitized","Hyperimmunized","Desensitization","Anti-HLA Antibodies","CD34+ Cells","Transplant Immunology","End-Stage Kidney Disease","Immune Reset","RECRUITING","2026-06-02",{"date":49,"type":50},"2026-06-04","ACTUAL",{"date":52,"type":50},"2024-02-01",{"date":54,"type":22},"2028-06",{"name":56,"class":57},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":58},"100619916","early-phase-1-car-t-therapy-targeting-cd19-and-bcma-in-highly-sensitized-kidney-transplant-participants-100619916","NCT07350837","CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants","An Early-Phase Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting CD19 and B Cell Maturation Antigen (BCMA), for Desensitization in Highly Sensitized Participants With End Stage Kidney Disease Awaiting Kidney Transplant","Inclusion Criteria:\n\n* 1\\. Adult men or women aged 18 to 65 years with end-stage kidney disease who are waiting for kidney transplant and require desensitization to enable safe kidney transplant.\n\n  2\\. Cohort 1:\n* A living donor who meets criteria for kidney donation based on national and local center-specific guidelines has been identified\n* Highly sensitized participants with a requirement of positive flow cytometry crossmatch, resulting from at least one DSA detected using Luminex SAB during or before Screening\n* A positive virtual crossmatch, using Luminex SAB (MFI ≥ 2000), obtained within 30 days of Screening and during Screening\n\nCohort 2:\n\n* PRA greater than or equal to 80% which is consistent with highly sensitized based on national criteria\n* At least one anti-HLA antibody that is unacceptable for kidney transplantation 3. High-resolution HLA typing for both the recipient and the donor within 2 years of Screening.\n\n  4\\. The participant is currently eligible for transplantation according to local standards if a graft becomes available upon completion of treatment with the study intervention.\n\n  5\\. Hemoglobin ≥ 8 g\u002FdL. 6. ANC ≥ 800\u002FμL. 7. Absolute lymphocyte count ≥ 2000\u002FμL or CD3 T cell count ≥ 500\u002FμL. 8. Platelet count ≥ 75000\u002FμL. 9. Vaccinations must be up to date in accordance with the national and local center guidance for transplant participants.\n\n  10\\. Positive for EBV capsid IgG. 11. Testing for latent TB infection must be negative within 3 months prior to Screening. Testing should be conducted using either a purified protein derivative or an IFN-γ release assay (ie, QuantiFERON-TB or T-SPOT.TB). Participants with a positive test for latent TB infection must complete appropriate therapy for LTBI.\n\nA participant is considered eligible if he\u002Fshe has a negative test for LTBI within 3 months prior to Screening, or if he\u002Fshe has completed appropriate LTBI therapy prior to transplantation. Treatment for latent TB infection should follow national guidelines.\n\n12\\. Participants must be willing to be hospitalized for at least 2 weeks from the time of AZD0120 infusion and must reside within 2 hours of the hospital for an additional 2 weeks following hospital discharge.\n\n13\\. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\n14\\. Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n15\\. Nonsterilized male participants who are sexually active with female partner of childbearing potential (See Appendix D for details):\n\n(a)Must agree to use one highly effective method of birth control for at least 3 years post AZD0120 infusion.\n\n(b)For participants who receive LDC but not AZD0120, the contraception time lasts from enrollment until 6 months after the last dose of LDC.\n\n(c)Must refrain from fathering a child or donating sperm within 3 years post AZD0120 infusion.\n\n(d)Female partner of a male participant must use one highly effective method of birth control for at least 3 years post AZD0120 infusion.\n\n16\\. Female participants (See Appendix D for details):\n\n1. FOCBP who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control for at least 3 years post AZD0120 infusion. For FOCBP participants who receive LDC but not AZD0120, the contraception time lasts from enrollment until 12 months after the last dose of LDC. Cessation of contraception after this point should be discussed with a responsible physician.\n2. All FOCBP must have a negative serum pregnancy test result 3 days prior to enrollment at Screening.\n3. Must refrain from donating ova within 3 years post AZD0120 infusion.\n\n   Exclusion Criteria:\n   * 1\\. Previous solid organ (except kidney) or bone marrow transplant. 2. Complement 3 glomerulopathy, immune-complex mediated membranoproliferative glomerulonephritis, or focal and segmental glomerulosclerosis as the cause of ESKD in the native kidney.\n\n     3\\. Severe peripheral arterial disease is defined by the presence of resting pain and\u002For non healing skin ulcers.\n\n     4\\. History of recurrent UTI; 2 in 6 months or 3 in one year. 5. Active invasive bacterial, viral or fungal infection. Additionally, any infection requiring hospitalization and IV antibiotics within 4 weeks of Screening or PO antibiotics within 2 weeks.\n\n     6\\. History of HIV regardless of treatment. 7. Evidence of active hepatitis B infection based on positive HBsAg or positive core antibody (anti HBc): participants with positive anti-HBc but negative HBsAg may be enrolled if the HBV DNA test result is negative during the Screening Period.\n\n     8\\. Evidence of active hepatitis C infection - Positive HCV antibody: Participants with positive HCV antibody and negative HCV RNA test during the Screening Period and absence of cirrhosis may be enrolled.\n\n     9\\. Detectable viral load for CMV, EBV, BKV or SARS-CoV-2, as determined by PCR. 10. CMV serology incompatible with donor (eg, a recipient with a CMV negative serology should not receive an organ from a CMV positive donor).\n\n     11\\. History of cirrhosis or severe liver disease, including abnormal liver profile (AST, ALT, or total bilirubin \\> 3 × ULN at Screening, except for participants whose hyperbilirubinemia is attributed to Gilbert's syndrome).\n\n     12\\. History of sickle cell disease or systemic amyloidosis. 13. Any chronic illness requiring uninterrupted anticoagulation or antiplatelet therapy, except for clinical stable and asymptomatic conditions (eg, chronic atrial fibrillation).\n\n     14\\. Active and severe disease requiring prolonged immunosuppressive therapy, except for low dose glucocorticoids (prednisone or prednisone equivalent \\\u003C 10 mg\u002Fday).\n\n     15\\. Receiving ongoing immunosuppressive treatment, including corticosteroids (excepting \\\u003C 10 mg\u002Fd of prednisone or prednisone equivalent), IV immunoglobulin, CYC, mycophenolic acid, or azathioprine, from 90 days prior to Screening.\n\n     16\\. CNI use within 14 days prior to Screening. 17. Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment.\n\n     18\\. Cardiac clearance for transplant \\> 6 months old and\u002For any of the following conditions: NYHA Class III or IV heart failure, unstable angina, LVEF \\\u003C 40%, a history of recent (within 6 months of Screening) myocardial infarction or presence of implantable cardioverter\u002Fdefibrillators and\u002For biventricular pacing.\n\n     19\\. Moderate-severe pulmonary function abnormality, defined as resting oxygen saturation \\\u003C 92% on room air or FEV1, total lung capacity, or DLCO (after correction for hemoglobin) \\\u003C 50% of predicted values within 6 months of Screening.\n\n     20\\. Known life-threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including DMSO.\n\n     21\\. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 years after receiving study intervention.\n\n     22\\. Plans to father a child while enrolled in this study or within 3 years after receiving study intervention.","65 Years",{"count":68,"type":22},12,[70],"EARLY_PHASE1","The purpose of this study is to assess the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with ESKD awaiting kidney transplant-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)- with or without living donors.",[34],[74,75,76,30],"Investigator-Initiated Trial","End-stage kidney disease","Dual directed CD19\u002FBCMA CAR-T desensitization therapy","2026-04-14",{"date":79,"type":50},"2026-04-16",{"date":81,"type":50},"2026-01-28",{"date":83,"type":22},"2029-12-31",{"name":85,"class":57},"Tongji Hospital"]