[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648944":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":26,"locations":31,"responsibleParty":47,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":87,"whyStopped":19,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous C7R.CD30-CAR-EBVSTs","EXPERIMENTAL","Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of autologous C7R.CD30-CAR-EBVSTs. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by intravenous infusion of autologous C7R.CD30-CAR-EBVSTs. Participants who meet protocol-defined retreatment criteria may receive additional treatment cycles.",[13],"Biological: Autologous C7R.CD30-CAR-EBVSTs",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Autologous Epstein-Barr virus-specific T lymphocytes genetically modified to express a constitutively active interleukin-7 receptor (C7R), a CD30-specific chimeric antigen receptor (CAR), and an inducible caspase 9 (iC9) safety switch. The investigational product is manufactured from autologous peripheral blood mononuclear cells and administered by intravenous infusion following lymphodepleting chemotherapy.",[9],null,[21,24],{"name":22,"affiliation":5,"role":23},"Helen Heslop, MD","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":5,"role":23},"Premal Lulla, MD",[27],{"name":25,"role":28,"phone":29,"phoneExt":19,"email":30},"CONTACT","713-441-1450","lulla@bcm.edu",[32],{"facility":33,"status":19,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Houston Methodist Hospital","Houston","Texas","77030","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-95.36327,29.76328,{"lat":43,"lon":42},[46],{"name":25,"role":28,"phone":29,"phoneExt":19,"email":30},{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[50],{"name":51,"class":6},"Baylor College of Medicine","100648944","phase-1-autologous-ic-nine-cd30-car-and-constitutive-il7r-expressing-ebvst-for-cd30-lymphoma-ancile-30-100648944",false,"NCT07729397","Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)","ANCILE-30","Procurement Inclusion Criteria:\n\nParticipants must meet the protocol-defined procurement eligibility criteria before collection of peripheral blood mononuclear cells for manufacture of the investigational product, including:\n\n1. Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.\n2. CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory.\n3. Age 16 to 75 years.\n4. Hemoglobin ≥7.0(may be transfused value).\n5. Karnofsky or Lansky score of \\> 60%\n6. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent.\n\nProcurement Exclusion Criteria:\n\n1. Active HIV or HTLV infection (testing may be pending at procurement).\n2. Active bacterial, fungal, or viral infection.\n\n   \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nTreatment Inclusion Criteria:\n\nParticipants with a successfully manufactured product must continue to satisfy the protocol-defined treatment eligibility criteria before receiving study treatment, including:\n\n1. Diagnosis and clinical course falling into one of the following categories:\n\n   * Hodgkin lymphoma\n   * CD30+ aggressive B-cell lymphoma\n   * ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma\n   * ALK-positive anaplastic T cell lymphoma\n2. CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy\n3. Age 16 to 75 years.\n4. Bilirubin ≤ 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin ≤ 3 times the upper limit of normal).\n5. AST ˂ 3 times the upper limit of normal\n6. Estimated GFR \\> 50 mL\u002Fmin\n7. Pulse oximetry of \\> 90% on room air\n8. Karnofsky or Lansky score of \\> 60%\n9. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after study is concluded. Male partner should use a condom\n10. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002FGuardian given copy of informed consent.\n\nTreatment Exclusion Criteria:\n\n1. Received an investigational cell therapy or vaccine within the past 6 weeks.\n2. Received an investigational small molecule within the past 2 weeks.\n3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.\n4. History of hypersensitivity reactions to murine protein-containing products\n5. Pregnancy or breastfeeding.\n6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion)\n7. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg\u002Fday of prednisone.\n8. Active significant, uncontrolled bacterial, viral or fungal infection.\n9. Symptomatic cardiac disease (NYHA Class III or IV disease).","ALL","16 Years","75 Years",{"count":63,"type":64},21,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30 (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas.\n\nParticipants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of the investigational product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by infusion of autologous C7R.CD30-CAR-EBVSTs.\n\nThe primary objective is to evaluate safety. Secondary and exploratory objectives include evaluation of antitumor effect, expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.",[70,71,72,73,74],"Diffuse Large B-Cell Lymphoma (DLBCL)","Hodgkin Lymphoma","Peripheral T-cell Lymphoma (PTCL)","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-Negative",[76,77,78,79,80,81,82,83,84,85,86],"CD30","Chimeric Antigen Receptor","CAR T Cells","Epstein-Barr Virus-Specific T Lymphocytes","EBVST","Constitutive IL7 Receptor","C7R","Gene Therapy","Cell Therapy","iC9","Inducible Caspase 9","NOT_YET_RECRUITING","2026-07-22",{"date":90,"type":91},"2026-07-27","ACTUAL",{"date":93,"type":64},"2027-01-15",{"date":95,"type":64},"2044-02-28",{"name":5,"class":6},1]