[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07729397":3,"trial-entities:NCT07729397":99,"trial-summary:NCT07729397":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":39,"interventions":42,"primary_outcomes":48,"secondary_outcomes":53,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":70,"locations":74,"central_contacts":90,"overall_officials":92,"references":97,"see_also_links":98},"NCT07729397","ANCILE-30","Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)","NOT_YET_RECRUITING","2044-02-28","2026-07","2026-07-27","2027-01-15","The Methodist Hospital Research Institute","OTHER",true,"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.","This is a Phase I study to evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes (EBVSTs) genetically modified to express a constitutively active interleukin-7 receptor (C7R) and a CD30-specific chimeric antigen receptor (CAR) (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas. The study will also evaluate the antitumor effect of C7R.CD30-CAR-EBVSTs, the expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.\n\nAutologous CD30 CAR T cells have demonstrated clinical activity in patients with relapsed or refractory CD30-positive lymphomas but have shown limited persistence. Epstein-Barr virus-specific T lymphocytes (EBVSTs) have demonstrated long-term persistence following adoptive transfer. In this study, EBVSTs are used as the cellular platform to express both a CD30 CAR and a constitutively active IL7 receptor (C7R). The investigational cell product also provides a mechanism for rapid elimination of transduced cells if clinically indicated.\n\nParticipants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of an autologous C7R.CD30-CAR-EBVST product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by intravenous infusion of C7R.CD30-CAR-EBVSTs. Participants who meet retreatment criteria, as defined in the protocol, may receive additional treatment cycles. Following treatment, participants will undergo scheduled follow-up evaluations including physical examinations, laboratory testing, and imaging studies to assess safety and disease status.\n\nBlood samples are collected at multiple time points after infusion to evaluate persistence of the infused cells. Tumor assessments are performed using imaging and, when clinically indicated, biopsy.\n\nParticipants are followed longitudinally for up to 15 years after the most recent infusion.",[18,19,20,21,22],"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",[24,25,26,27,28,29,30,31,32,33,34],"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","INTERVENTIONAL","TREATMENT",[38],"PHASE1",{"count":40,"type":41},21,"ESTIMATED",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47},"BIOLOGICAL","Autologous C7R.CD30-CAR-EBVSTs","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.",[45],[49],{"measure":50,"description":51,"timeFrame":52},"Incidence of Dose-Limiting Toxicities (DLTs)","Dose-limiting toxicity (DLT) is defined as any of the following considered possibly, probably, or definitely related to study cellular products: (1) Grade 5 event without disease progression; (2) CRS: Grade 4, or Grade 3 not improving to ≤Grade 2 within 72 hours despite therapy; (3) ICANS: Grade 4, or Grade 3 not improving within 72 hours despite therapy; (4) Grade ≥3 IEC-HS; (5) Grade 4 neutropenia or thrombocytopenia not attributable to underlying disease or lymphodepleting chemotherapy and not improving to ≤Grade 2 within 42 days, or Grade 3 thrombocytopenia with clinically significant major bleeding; (6) Grade ≥3 vital organ toxicity (except transient hepatic or renal abnormalities improving to ≤Grade 2 within 7 days); (7) other Grade 3 toxicities not attributable to underlying disease or lymphodepleting chemotherapy and not resolving to ≤Grade 2 within 72 hours; (8) Grade ≥2 allergic reaction to T-cell infusion.","From initiation of lymphodepleting chemotherapy through 28 days following the initial investigational T-cell infusion.",[54],{"measure":55,"description":56,"timeFrame":57},"Antitumor Effect","Antitumor effect will be assessed by investigator evaluation of objective response (complete response and partial response) using Lugano criteria.\\[","4 to 6 weeks after the initial C7R.CD30-CAR-EBVST infusion.","ALL","16 Years","75 Years",false,{"inclusion":63,"exclusion":68,"raw_text":69},[64,65,66,67],"Hodgkin lymphoma","CD30+ aggressive B-cell lymphoma","ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma","ALK-positive anaplastic T cell lymphoma 2. CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy 3. Age 16 to 75 years. 4. 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). 5. AST ˂ 3 times the upper limit of normal 6. Estimated GFR \\> 50 mL\u002Fmin 7. Pulse oximetry of \\> 90% on room air 8. Karnofsky or Lansky score of \\> 60% 9. 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 10. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002FGuardian given copy of informed consent.",[],"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).",[71,72,73],"CHILD","ADULT","OLDER_ADULT",[75],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":87},"Houston Methodist Hospital","Houston","Texas","77030","United States",[82],{"name":83,"role":84,"phone":85,"email":86},"Premal Lulla, MD","CONTACT","713-441-1450","lulla@bcm.edu",{"lat":88,"lon":89},29.76328,-95.36327,[91],{"name":83,"role":84,"phone":85,"email":86},[93,96],{"name":94,"affiliation":12,"role":95},"Helen Heslop, MD","PRINCIPAL_INVESTIGATOR",{"name":83,"affiliation":12,"role":95},[],[],{"nct_id":4,"conditions":100,"biomarkers":104},[22,21,101,102,103],"Diffuse Large B-Cell Lymphoma","Hodgkin's Granuloma","Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":14,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is a Phase I interventional study designed to evaluate the safety of the C7R.CD30-CAR-EBVSTs treatment. It plans to enroll 21 participants.","completed","ANCILE-30: C7R.CD30-CAR-EBVSTs for CD30 Lymphoma","This study, called ANCILE-30, is testing a new cell therapy called C7R.CD30-CAR-EBVSTs for people aged 16 to 75 with certain types of lymphoma that have come back or are not responding to treatment. These include Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-cell Lymphoma (PTCL), and Anaplastic Large Cell Lymphoma. The treatment uses your own immune cells (Epstein-Barr virus-specific T lymphocytes) that are specially modified to find and fight cancer cells with a marker called CD30. The main goal of this study is to see how safe this new treatment is. Researchers will also look at how well the treatment works against the cancer and how the modified cells behave in your body. The study plans to enroll 21 participants, and its current status is unclear.","The primary safety outcomes are measured from the start of chemotherapy through 28 days after the initial cell infusion.",127,"You would first have your blood cells collected to create the treatment. If the treatment is successfully made and you still meet the criteria, you would receive chemotherapy followed by an infusion of the C7R.CD30-CAR-EBVSTs.","Not stated in the trial record.",[],"v2"]