[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kure Cells, INC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100639037","phase-1-study-to-evaluate-the-safety-of-uf-kure-bcma-car-t-cells-in-advanced-myeloma-100639037",false,"NCT07611149","Study to Evaluate the Safety of UF-KURE-BCMA CAR T-Cells in Advanced Myeloma","A Phase 1, Single-Arm, Open-Label Study to Evaluate the Safety of UF-KURE-BCMA Cells in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\nSubjects must meet ALL of the following criteria to be eligible for study enrollment:\n\n1. Age: ≥18 years at time of signing informed consent\n2. Diagnosis: Documented multiple myeloma meeting one of the following:\n\n   * Relapsed disease: Progression after achieving at least minimal response (MR) to prior therapy\n   * Refractory disease: Non-responsive or progressive disease while on therapy or within 60 days of last treatment (in subjects who achieved ≥MR on prior therapy)\n3. Prior Therapy:\n\n   * Received ≥3 prior lines of anti-myeloma therapy\n   * Prior therapy must include:\n\n   At least one proteasome inhibitor At least one immunomodulatory drug (e.g., lenalidomide, pomalidomide, thalidomide) At least one anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab) o Prior anti-BCMA CAR-T therapy is permitted if subject achieved PFS ≥6 months post-infusion\n4. Measurable Disease: At least one of the following at screening (for response assessment eligibility):\n\n   * Serum M-protein ≥0.5 g\u002FdL by protein electrophoresis (SPEP)\n   * Urine M-protein ≥200 mg\u002F24 hours by protein electrophoresis (UPEP)\n   * Serum free light chain (FLC) difference ≥10 mg\u002FdL with abnormal FLC ratio Note: Subjects with non-measurable disease may enroll for safety assessment\n5. Performance Status: ECOG Performance Status 0-2 (see Appendix A)\n6. Organ Function: Adequate organ function as defined by:\n\n   Hepatic:\n\n   o Total bilirubin ≤2× institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome\n   * AST and ALT ≤2.5× institutional ULN\n\n   Renal:\n\n   o Calculated creatinine clearance ≥30 mL\u002Fmin (Cockcroft-Gault formula)\n\n   Cardiac:\n\n   o Left ventricular ejection fraction (LVEF) ≥45% by echocardiogram or MUGA\n\n   Pulmonary:\n\n   o ≤Grade 1 dyspnea\n\n   o Oxygen saturation ≥92% on room air\n\n   o If PFTs performed: FEV₁ ≥50% predicted and DLCO ≥40% predicted (corrected for hemoglobin)\n7. Prior Therapy Washout:\n\n   o ≥2 weeks since last radiation or systemic anti-myeloma therapy (standard agents)\n\n   o ≥4 weeks since last investigational therapy\n\n   o ≥6 weeks since autologous stem cell transplant\n8. Informed Consent: Ability to understand and willingness to provide written informed consent\n9. Contraception Requirements (for subjects of reproductive potential):\n\nFemale subjects:\n\no Women of childbearing potential must: Have negative serum pregnancy test at screening Agree to use highly effective contraception (failure rate \\\u003C1% per year) from enrollment through 6 months post-CAR-T infusion\n\n* Acceptable methods: bilateral tubal ligation, male partner sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing IUD, copper IUD\n* Sexual abstinence is acceptable if consistent with subject's preferred lifestyle\n\nMale subjects:\n\n* Must agree to use condom plus effective contraception if partner is of childbearing potential\n* Must refrain from sperm donation from enrollment through 6 months post-CAR-T infusion\n\nExclusion Criteria:\n\nSubjects meeting ANY of the following criteria will be excluded:\n\n1. Disease-Specific Exclusions:\n\n   * Active CNS involvement by multiple myeloma\n   * Plasma cell leukemia\n   * History of allogeneic hematopoietic stem cell transplantation\n2. Malignancy Exclusions:\n\n   o Second active malignancy, except: Non-melanoma skin cancer Carcinoma in situ (cervix, bladder, breast) Stage 1 uterine cancer Localized prostate cancer\n3. Cardiovascular Exclusions:\n\n   * New York Heart Association (NYHA) Class IV congestive heart failure\n   * Unstable angina pectoris\n   * Clinically significant cardiac arrhythmias\n   * Myocardial infarction, stroke, or TIA within 6 months of enrollment\n4. Infectious Disease Exclusions:\n\n   * Known HIV infection or AIDS-related illness\n   * Active hepatitis B or C infection:\n\nPositive HBsAg, or Positive anti-HBc or anti-HCV with detectable viral nucleic acid by PCR\n\n* Active infection requiring systemic therapy 5. Neurological Exclusions:\n* History of clinically relevant CNS pathology including:\n\nEpilepsy or seizure disorders Paresis, aphasia Uncontrolled cerebrovascular disease Severe brain injury Dementia Parkinson's disease 6. Autoimmune Disease:\n\n* Active autoimmune disease requiring systemic immunosuppression \\>15 mg\u002Fday prednisone equivalent within past 6 months\n* Examples: rheumatoid arthritis, lupus","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this study is to evaluate the safety of a new type of CAR T-cell, UF-KURE-BCMA, for the treatment of patients with advanced multiple myeloma that has not responded to other therapies. The main question is whether the use of these new CAR T-cells is safe for patients with this condition. Secondarily, the study will also look at the response of myeloma to this therapy.",[26,27],"Multiple Myeloma in Relapse","Multiple Myeloma, Refractory","NOT_YET_RECRUITING","2026-05-22",{"date":31,"type":32},"2026-05-28","ACTUAL",{"date":34,"type":20},"2026-09-01",{"date":36,"type":20},"2028-12-30",{"name":38,"class":39},"Kure Cells, INC","INDUSTRY",""]