[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649540":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":21,"responsibleParty":41,"collaborators":21,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":21,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":21,"enrollmentInfo":52,"targetDuration":21,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":72,"whyStopped":21,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":21},{"fullName":5,"class":6},"Umoja Biopharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"UB-VV400 + rapamycin","EXPERIMENTAL","A single dose of UB-VV400 will be administered followed by treatment with rapamycin.",[13,14],"Genetic: UB-VV400","Drug: Rapamycin (sirolimus)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"GENETIC","UB-VV400","UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Rapamycin (sirolimus)","Rapamycin is a drug approved by the FDA for indications unrelated to cancer.",[9],[28],"Rapamune",[30],{"name":31,"affiliation":5,"role":32},"Luke Walker, MD","STUDY_DIRECTOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":21,"email":37},"CONTACT","206-227-5056","luke.walker@umoja-biopharma.com",{"name":39,"role":35,"phone":21,"phoneExt":21,"email":40},"Christine Dehner","christine.dehner@umoja-biopharma.com",{"type":42,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100649540","phase-1-a-phase-12-study-of-ub-vv400-with-rapamycin-in-relapsedrefractory-b-cell-malignancies-100649540",false,"NCT07735533","A Phase 1\u002F2 Study of UB-VV400 With Rapamycin in Relapsed\u002FRefractory B-cell Malignancies","A Phase 1\u002F2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies","Inclusion Criteria:\n\n1. 18 years or older\n2. Provides voluntary written informed consent\n3. Relapsed or refractory large B-cell lymphoma (LBCL)\n4. Measurable disease according to Lugano 2014 criteria\n5. Confirmed CD22 expression\n6. No serious concomitant diseases or active\u002Funcontrolled infections\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n8. Adequate organ function\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding\n2. Current isolated central nervous system (CNS) involvement\n3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor \\[TCR\\] fusion constructs, TCR T cells, and CAR T cells)\n4. History of or active human immunodeficiency virus (HIV)\n5. Active or chronic hepatitis B, or active hepatitis C\n6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease\n7. Ongoing CNS disease that would preclude neurologic assessment\n8. Uncontrolled angina or other acute heart disease\n9. Currently receiving treatment in another interventional clinical trial.","ALL","18 Years",{"count":53,"type":54},274,"ESTIMATED","INTERVENTIONAL",[57,58],"PHASE1","PHASE2","This study is a Phase 1\u002F2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed\u002Frefractory B-cell malignancies, including large B-cell lymphoma (LBCL).",[61,62,63,64,65,66,67],"Lymphoma, B Cell","Lymphoma Non-Hodgkin","High Grade B Cell Lymphoma","Richter Transformation Lymphoma","Grade 3b Follicular Lymphoma","Primary Mediastinal B Cell Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)",[69,70,71],"CAR T","chimeric antigen receptor","CD22","NOT_YET_RECRUITING","2026-08-13",{"date":75,"type":76},"2026-08-17","ACTUAL",{"date":78,"type":54},"2026-08",{"date":80,"type":54},"2031-08",{"name":5,"class":6}]