[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Catherine Bollard\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100224790","phase-1-multi-institutional-prospective-research-of-expanded-multi-antigen-specifically-oriented-lymphocytes-for-the-treatment-of-very-high-risk-hematopoietic-malignancies-100224790",false,"NCT02203903","Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies","Multi-institutional Prospective Phase I Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies","RESOLVE","Recipient Inclusion Criteria to Enter Protocol:\n\n* Aged 6 months to 80 years.\n* Anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant.\n* Patients with high risk AML and MDS who have received or will receive an allo-HSCT and have not had hematologic relapse of disease.\n* Karnofsky\u002FLansky score of ≥ 50.\n* Agree to use contraceptive measures during study protocol participation (when age appropriate).\n* Patient or parent\u002Fguardian capable of providing informed consent.\n* T cell chimerism \\> 94% if collected from recipient of allo-HSCT\n\nRecipient Exclusion Criteria to Enter Protocol:\n\n* Patients with uncontrolled infections.\n* Current evidence of GVHD \\> grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.\n* Pregnancy (female of childbearing potential).\n\nRecipient Inclusion Criteria for TAA-T Administration:\n\n* Patients with high risk AML and MDS who have received an allo-HSCT and have not had hematologic relapse of disease.\n* Steroids less than 0.5 mg\u002Fkg\u002Fday prednisone or equivalent in the context of no escalation of treatment within the preceding 2 weeks\n* Karnofsky\u002FLansky score of ≥ 50.\n* Bilirubin \\\u003C 2.5 mg\u002FdL, AST\u002FALT \\\u003C5x upper limit of normal, Serum creatinine \\\u003C 1.0 or 2x the upper limit of normal (whichever is higher).\n* Pulse oximetry of \\> 90% on room air.\n* Absolute neutrophil count \\> 250\u002F µL (may be supported with Granulocyte colony-stimulating factor (GCSF)).\n* Agree to use contraceptive measures during study protocol participation (when age appropriate).\n* Patient or parent\u002Fguardian capable of providing informed consent.\n* LVEF \\> 50% or LVSF \\> 27% (performed within the last 6 months) if history of TBI \\>500 cGy for arm A and B.\n* Total chimerism \\> 50%; or if cancer cells preclude this, donor T cell chimerism \\> 50% (performed within the last 6 months).\n\nRecipient Exclusion Criteria for TAA-T Administration:\n\n* Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T infusion.\n* No investigational therapies (under IND, not extensively studied in the current clinical context) within 28 days prior to TAA-T infusion.\n* Uncontrolled infections.\n* Active Bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.\n* Active acute GVHD or chronic GVHD requiring escalation of treatment within preceding 2 weeks of any grade is exclusion for Arm C patients.\n* Pregnancy or lactating (female of childbearing potential).\n* Patients who have or will be receiving 2nd allogeneic HSCT\n\nDonor Inclusion Criteria:\n\n* Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have undergone eligibility evaluation as per FDA regulations outlined in 21 CFR 1271 subpart C. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for TAA-T generation provided that there are no new reasons for ineligibility since the transplant donor evaluation.\n* Aged 6 months to 80 years.\n* Donor or guardian of pediatric capable of providing informed consent.\n* Donor must have completed infectious Disease (ID) testing up to 7 days before or after the collection of blood from the donor (related or unrelated) for TAA-T manufacturing. The following tests will be performed:\n\n  * HBsAg\n  * HB Core antibody\n  * HIV1\u002F2 NAT\n  * Syphilis (T. Pallidum IgG)\n  * HTLV I\u002FII\n  * CMV total\n  * HBV\u002FHCV NAT\n  * West Nile Virus NAT.\n  * Cruz (Chagas) antibody\n  * Hepatitis C\n* Female donors of childbearing age must have a negative pregnancy test within 7 days of blood collection for TAA-T manufacturing.\n\nDonor Exclusion Criteria:\n\n* Donation of cells would pose a physical or psychological risk to the donor.\n* Female donors of childbearing age who are known to be pregnant.","ALL","6 Months","80 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.",[28],"Relapsed\u002FRefractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS","RECRUITING","2025-05-29",{"date":32,"type":33},"2025-05-31","ACTUAL",{"date":35,"type":33},"2015-01-01",{"date":37,"type":22},"2027-06-28",{"name":39,"class":40},"Catherine Bollard","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100331417","phase-1-adoptive-cord-blood-immunotherapy-for-ebv-cmv-bkv-and-adenovirus-reactivationinfection-or-prophylaxis-100331417","NCT03594981","Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation\u002FInfection or Prophylaxis","Adoptive Cord Blood ImmunotHerapy Using Expanded Cord Blood T Cells for EBV, CMV, BKV and Adenovirus Reactivation\u002FInfection or ProphylaxiS","Inclusion Criteria:\n\nInclusion Criteria at the Time of Procurement\n\n* Pediatric and adult patients (there are no lower and upper age limits for patients) with malignant or nonmalignant diseases who are candidates for transplant.\n* Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6\u002F6 HLA class I (serological) and II (molecular) antigens. The unit selected for CTL expansion must be either:\n\n  1. be cryopreserved in two fractions, with a minimum of 2.5x107 total nucleated cells (TNC) per kg pre-thaw in the fraction which will be used for the primary transplant. The remaining fraction will be used to generate the CTLs to give at day 30 or beyond as described below. OR\n  2. be cryopreserved with a cell dose that totals \\> 3x10e7 TNC per kg pre thaw. On thaw, 20% of the total volume will be used for CTL manufacture to give at day 30 or beyond and the remaining 80% will be used for the primary transplant.\n  3. For recipients of double CBT, if possible both CB units should be cryopreserved in two fractions and T-cells will be made from both units if possible.\n\nInclusion Criteria at the Time of CTL Infusion\n\n* Recipients of at least one unmanipulated cord blood unit as described above (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV\u002FAdenoviral\u002FBKV and\u002For EBV infection or reactivation.\n* Lansky\u002FKarnofsky scores ≥60\n* Absolute neutrophil count (ANC) greater than 500\u002Fu\n* No evidence of GVHD \\> Grade II at time of enrollment\n* Life expectancy \\> 30 days\n* Absence of severe renal disease (Creatinine \\\u003C 3x normal for age)\n* Absence of severe hepatic disease. Direct bilirubin must be \\\u003C 3 mg\u002Fdl and AST \\\u003C 5x upper limit of normal\n* Patient must be at least 30 days post transplant to be eligible to receive CTL\n* Written informed consent and\u002For signed assent line from patient, parent or guardian\n\nExclusion Criteria:\n\nExclusion Criteria at the Time of Procurement\n\n* Pregnant or lactating\n* Patients with active central nervous system disease\n* Patients with Karnofsky performance status \\\u003C70%\n* Patients with grade 3 or 4 or primary myelofibrosis\n* Patients with suitable related donors Exclusion Criteria at the Time of CTL Infusion\n* Pregnant or lactating\n* Patient on Fi02 of \\>60%\n* Unable to wean steroids to ≤0.5 mg\u002Fkg\u002Fday prednisone or equivalent\n* Patients with Grade 3 hyperbilirubinemia\n* Patients with other uncontrolled infections (except CMV and\u002For adenovirus and\u002For EBVemia and\u002For BK viruria\u002Fviremia). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease\n* Patients who have received investigational (IND) product within 28 days of screening for CTL infusion under this study",{"count":49,"type":22},36,[25,51],"PHASE2","This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating.\n\nThe scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells\u002Fm2, 2 x107cells\u002Fm2 and 5x107cells\u002Fm2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.",[54],"Viral Infection","2024-08-27",{"date":57,"type":33},"2024-08-28",{"date":59,"type":33},"2018-01-24",{"date":61,"type":22},"2025-11",{"name":39,"class":40},""]