[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639037":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":28,"responsibleParty":39,"collaborators":41,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":28,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":28,"enrollmentInfo":56,"targetDuration":28,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":28,"overallStatus":66,"whyStopped":28,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":28},{"fullName":5,"class":6},"Kure Cells, INC","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Lower Dose Level","ACTIVE_COMPARATOR","Lower Dose (Level -1): 3 × 10⁶ cells (≥50 kg)\u002F\u002F 2 × 10⁶ cells (\\\u003C50 kg)",[13],"Biological: Administration of CAR T-cells at 3 different dose levels",{"label":15,"type":10,"description":16,"interventionNames":17},"Starting Dose Level","Starting Dose Level (Level 1) : 10 × 10⁶ cells (≥50 kg) \u002F 7 × 10⁶ cells (\\\u003C50 kg)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Higher Dose Level","Higher Dose Level (Level 2): 15 × 10⁶ cells (≥50 kg) \u002F 10 × 10⁶ cells (\\\u003C50 kg)",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Administration of CAR T-cells at 3 different dose levels","The patients will receive one of 3 dose levels as outlined above.",[19,9,15],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"DANIEL Couriel, MD, MS, MBA","CONTACT","7343539036","daniel@cellserveglobal.com",{"name":36,"role":32,"phone":37,"phoneExt":28,"email":38},"Ola Soliman, MD","6478650773","olaselkadi@gmail.com",{"type":40,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[42,45],{"name":43,"class":44},"CellServe LLC","UNKNOWN",{"name":46,"class":44},"Roya Clinical","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":57,"type":58},12,"ESTIMATED","INTERVENTIONAL",[61],"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.",[64,65],"Multiple Myeloma in Relapse","Multiple Myeloma, Refractory","NOT_YET_RECRUITING","2026-05-22",{"date":69,"type":70},"2026-05-28","ACTUAL",{"date":72,"type":58},"2026-09-01",{"date":74,"type":58},"2028-12-30",{"name":5,"class":6}]