[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"warm-autoimmune-hemolytic-anemia-waiha\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:warm-autoimmune-hemolytic-anemia-waiha":27},{"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":25,"conditions":26,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100635208","phase-1-safety-and-preliminary-efficacy-of-ctx112-in-adult-participants-with-relapsedrefractory-hematologic-autoimmune-disease-100635208",false,"NCT07549698","Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed\u002FRefractory Hematologic Autoimmune Disease","A Phase 1\u002F2 Dose Evaluation Trial of the Safety and Preliminary Efficacy of Anti CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Participants With Relapsed\u002FRefractory Hematologic Autoimmune Disease","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Participants must voluntarily sign a written informed consent and be willing and able to comply with all trial requirements.\n3. Adequate hematologic, renal, liver, cardiac and pulmonary function.\n4. Participants must agree to use acceptable methods of contraception.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other trial procedures.\n6. Diagnosis of relapsed\u002Frefractory primary Immune Thrombocytopenic Purpura (ITP) or Warm Autoimmune Hemolytic Anemia (WAIHA)\n\nExclusion Criteria:\n\n1. Prior treatment with anti-CD19 therapy or any gene therapy or genetically modified cell therapy.\n2. Prior solid organ (e.g., heart, liver, kidney, lung) transplant or hematopoietic cell transplant.\n3. Severe active or history of central nervous (CNS) involvement.\n4. Presence of other active autoimmune disease or other conditions that are likely to pose increased safety risks and\u002For confound disease assessments, or pose significant risk to those receiving CAR T cell therapy.\n5. History of primary or secondary immunodeficiency.\n6. Presence or history of certain bacterial, viral or fungal infection\n7. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).\n8. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.\n9. History or current diagnosis that requires uninterrupted, ongoing anticoagulation.\n10. Pregnant or lactating.\n11. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a single-arm, open-label, multicenter, ascending dose Phase 1\u002F2 trial evaluating the safety and preliminary efficacy of CTX112 or Zugocabtagene geleucel (zugo-cel) in adult participants with relapsed\u002Frefractory primary Immune Thrombocytopenia (ITP) and relapsed\u002Frefractory primary Warm Autoimmune Hemolytic Anemia (wAIHA).",[27,28,29,30],"Warm Autoimmune Hemolytic Anemia (WAIHA)","ITP - Immune Thrombocytopenia","Warm Autoimmune Hemolytic Anemia","Immune Thrombocytopenic Purpura",[32,33,34,35,36,37,38,39,30,40],"CD19","CTX112","Zugocabtagene geleucel","zugo-cel","CAR-T","ITP","warm autoimmune hemolytic anemia","wAIHA","Immune Thrombocytopenia","RECRUITING","2026-06-11",{"date":44,"type":45},"2026-06-15","ACTUAL",{"date":47,"type":20},"2026-06",{"date":49,"type":20},"2033-12",{"name":51,"class":52},"CRISPR Therapeutics AG","INDUSTRY",3]