[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100649791","phase-1-a-phase-1b2a-study-of-velinotamig-in-adults-with-relapsedrefractory-itp-and-waiha-100649791",false,"NCT07738822","A Phase 1b\u002F2a Study of Velinotamig in Adults With Relapsed\u002FRefractory ITP and wAIHA","A Phase 1b\u002F2a, Open-label Study of Velinotamig for the Treatment of Adults With Relapsing and Refractory Immune Thrombocytopenia and Warm Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Age ≥18 to 80 years\n* Active autoimmune cytopenia\n* Relapsed\u002Frefractory after standard of care therapy\n* ECOG performance status 2 or lower\n\nLaboratory parameters including the following:\n\n* Absolute lymphocyte count (ALC) ≥0.5 × 109\u002FL\n* Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL\n* Hemoglobin ≥6.5 g\u002FdL\n* Total bilirubin ≤1.5 × ULN unless related to Gilbert's syndrome\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 × ULN, unless attributable to hemolysis\n* Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥30 mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History of clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with subject safety, study evaluations, and\u002For study procedures, would put the patient at undue risk or confound study results\n* Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection\n* Active or latent tuberculosis (TB) evidenced by a positive or indeterminate interferon gamma release assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB\n* Presence of New York Heart Association class III or IV congestive heart\n* Primary immunodeficiency or history of recurrent infections\n* Previous treatment with a BCMA-targeted therapy\n* Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1\n* History of solid organ transplant\n* Planned major surgery in the timeframe of the dosing period","ALL","18 Years","80 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Phase 1b\u002F2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA) to evaluate safety and tolerability.",[28,29],"Immune Thrombocytopenia (ITP)","Warm Autoimmune Hemolytic Anemia (WAIHA)",[31,32,33,34,35,36,37,38,39,40],"Autoimmune disease","Blood platelet disorder","Thrombocytopenia","Anemia","Hemolytic anemia","Red blood cell disorder","Autoimmune cytopenia","Warm Autoimmune Hemolytic Anemia","Immune Thrombocytopenia","Immune Thrombocytopenic Purpura","NOT_YET_RECRUITING","2026-07-28",{"date":44,"type":45},"2026-07-31","ACTUAL",{"date":47,"type":21},"2026-12",{"date":49,"type":21},"2031-01",{"name":51,"class":52},"Cullinan Therapeutics Inc.","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100635208","phase-1-safety-and-preliminary-efficacy-of-ctx112-in-adult-participants-with-relapsedrefractory-hematologic-autoimmune-disease-100635208","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.",{"count":62,"type":21},60,[24,25],"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).",[29,66,38,40],"ITP - Immune Thrombocytopenia",[68,69,70,71,72,73,74,75,40,39],"CD19","CTX112","Zugocabtagene geleucel","zugo-cel","CAR-T","ITP","warm autoimmune hemolytic anemia","wAIHA","RECRUITING","2026-07-21",{"date":79,"type":45},"2026-07-22",{"date":81,"type":21},"2026-06",{"date":83,"type":21},"2033-12",{"name":85,"class":52},"CRISPR Therapeutics AG",10]