[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BlueSphere Bio, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100636507","phase-1-dose-finding-study-to-evaluate-the-safety-of-bsb-2002-in-relapsed-or-refractory-acute-myeloid-leukemia-aml-patients-with-npm1-mutation-100636507",false,"NCT07566585","Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation","A Phase 1 Multicenter Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation","Inclusion Criteria:\n\n1. Male or female patients, ages 18 years or older,\n2. AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy,\n\n   1. which is relapsed (after previously complete remission, CR, CRh or CRi), or\n   2. refractory (failed to achieve complete remission) to the last treatment\\*, \\*Primary refractory patients should have received at least two cycles of induction treatment\n3. Patients who are MRD positive by NGS for NPM1 after being MRD negative following the last treatment\n4. HLA-A\\*02:01,\n5. Positive for NPM1 mutation type A, D, G or H (see Appendix 3)2\n6. Adequate venous access for apheresis or agree to use of a central line for apheresis collection,\n7. Willing and able to provide informed consent and adhere to all study requirements.\n\nExclusion Criteria:\n\n1. Leukemic blast count of \\>20,000\u002Fμl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible.\n2. Patients with extramedullary only AML.\n3. Patients that are candidates for hematopoietic stem cell transplant.\n4. Patients that are eligible to receive an approved targeted therapy.\n5. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-2002 (day 1).\n6. Subject has had hematopoietic stem cell transplant (HSCT) and has any of the following:\n\n   1. Is within 3 months of transplant;\n   2. Has clinically significant graft-versus-host disease requiring systemic treatment;\n   3. Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant.\n7. Other malignancy that requires treatment.\n8. Uncontrolled bacterial, viral, or fungal infections at time of enrollment.\n9. Active Hepatitis B or C infection.\n10. Seropositive for Human Immunodeficiency Virus-1 or -2.\n11. CNS involvement refractory to intrathecal chemotherapy and\u002For standard cranial- spinal radiation.\n12. Subject has congestive heart failure NYHA class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless an echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.\n13. Renal insufficiency, with estimated creatinine clearance of \\\u003C 40 ml\u002Fmin\u002F1.73m2 by the Cockcroft-Gault equation with adjustment if the weight is ≥ 125% of ideal body weight OR inadequate renal function defined by serum creatinine \\> 1.6 mg\u002FdL\n14. Total bilirubin \\> 2x upper limit of normal (unless attributed to Gilbert's Syndrome).\n15. AST or ALT \\> 3x upper limit of normal.\n16. Pregnant or lactating women.\n17. Eastern Cooperative Oncology Group (ECOG) performance status \\>2.\n18. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids at any dose)\n19. Women of childbearing potential (WOCBP) and men who are fertile and are unwilling to use an effective birth control method or abstinence for 12 months. Effective forms of birth control are listed in the Contraception section.\n20. Any condition, in the judgement of the Investigator, that would interfere with study participation, pose a significant risk to the patient, or interfere with study data interpretation.","ALL","18 Years",{"count":19,"type":20},19,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML). It will evaluate the safety of BSB-2002 and also determine whether it works to prevent relapse of your cancer.",[26,27,28],"AML - Acute Myeloid Leukemia","AML With Mutated NPM1","AML, Adult Recurrent",[30,31],"TCR","T-cell therapy","RECRUITING","2026-04-27",{"date":35,"type":36},"2026-05-05","ACTUAL",{"date":38,"type":36},"2026-04-21",{"date":40,"type":20},"2027-09",{"name":42,"class":43},"BlueSphere Bio, Inc","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100570200","phase-1-bsb-1001-in-patients-undergoing-hla-matched-allogenic-hematopoietic-stem-cell-transplant-for-aml-all-or-mds-100570200","NCT06704152","BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS","A Phase 1\u002F2a Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS","Inclusion Criteria:\n\n1. Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.\n2. Any of the following high-risk hematologic malignancies:\n\n   1. AML diagnosed which has been treated with at least two lines of therapy\\* Refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high-risk disease For patients in remission meeting criteria a, consolidation regimens would be considered another line of therapy of eligibility purposes\n   2. ALL which has been with abnormal lymphoblasts ≥5% and up to 25% in bone marrow OR persistent disease-defining cytogenetic abnormality or MRD positive\n   3. MDS after at least one line of therapy, which includes hypomethylating agent(s) and must be high or very high risk by Revised International Prognostic Scoring System (IPSS-R), monosomy, or complex karyotype or TP53 mutation.\n   4. In the expansion phase AML patients diagnosed which has been treated with at least two lines of therapy, and refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high- risk disease\n3. HLA-A\\*02:01 AND HA-1 positive (either H\u002FH or H\u002FR).\n4. Suitable for one of the approved conditioning regimens as defined in the protocol.\n5. Patient must have an identified donor that is HA 1-negative with 10\u002F10 matched related or unrelated donor\n\nExclusion Criteria:\n\n1. Weight \\> 100 kg.\n2. Prior history of allogeneic stem cell transplantation\n3. Prior history of autologous stem cell transplantation within 1 year prior to the planned dosing of BSB-1001 (day 0)\n4. Previous genetically engineered chimeric antigen receptor T Cell therapy (CAR-T), approved or investigational, within 2 years of screening, with the exception of patients with ALL previously treated with an autologous CAR-T product.\n5. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0).\n6. History of treatment with checkpoint inhibitor therapy within 3 months of transplantation.\n7. Other malignancy with life expectancy \\\u003C 1year.\n8. Pregnant or lactating women.\n9. Uncontrolled bacterial, viral, or fungal infections at time of enrollment.\n10. Past or current viral infections as defined in the protocol.\n11. CNS involvement refractory to intrathecal chemotherapy and\u002For standard cranial- spinal radiation. 12 Karnofsky Performance Score \\\u003C 60%.\n\n13\\. Inadequate organ function as defined in protocol.","70 Years",{"count":54,"type":20},38,[23,56],"PHASE2","The goal of this clinical trial is to test BSB-1001 which is a new type of cellular therapy to treat blood cancers (AML, ALL and MDS). It will evaluate the safety of BSB-1001 and also determine whether it works to prevent relapse of your cancer.",[28,59,60],"ALL, Recurrent, Adult","MDS",[62],"TCR, T-cell therapy","2025-09-17",{"date":65,"type":36},"2025-09-18",{"date":67,"type":36},"2025-02-04",{"date":69,"type":20},"2029-03",{"name":42,"class":43},6,""]