[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376326":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":34,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":22,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":37,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CTL 19 : T cell therapy","EXPERIMENTAL","Level 1: 1 x 104 cells\u002Fkg of recipient, Level 2: 5 x 104 cells\u002Fkg, Level 3: 25 x 104 cells\u002Fkg, Level 4: 50 x 104 cells\u002Fkg, Level 5: 100 x 104 cells\u002Fkg. After study of toxicity of the 4 injected patients, choice has been made to stop the CRM method to choose the dose and to test only 2 doses for each last patients : 100 x 10\\^4 cells\u002Fkg (actual level 5) and 500 x 10\\^4 cells\u002Fkg (choice based on compassionnal injections data at the level 5)",[13],"Combination Product: CTL 19",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","CTL 19","Patients candidate for allogeneic transplantation who are both HLA-DPB1\\*04:01 and with a HLA-DPB1\\*04:01-expressing hematological malignancy (almost 100% of cases) with a donor HLA-DPB1\\*04:01 negative, will be proposed to receive one single infusion of the T cell clone at 4-5 months post-transplantation, once the immunosuppression by cyclosporine and\u002For mycophenolate mofetil has been discontinued.",[9],[21],"T cell therapy",null,[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"thierry GUILLAUME, MD","CONTACT","02.40.08.48.45","+33","thierry.guillaume@chu-nantes.fr",{"name":31,"role":26,"phone":32,"phoneExt":28,"email":33},"Beatrice CLEMENCEAU, PhD","02 28 08 02 30","beatrice.clemenceau@univ-nantes.fr",[35],{"facility":36,"status":37,"city":38,"state":22,"zip":22,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Chu de Nantes","RECRUITING","Nantes","France","FR",{"type":42,"coordinates":43},"Point",[44,45],-1.55336,47.21725,{"lat":45,"lon":44},[48],{"name":49,"role":26,"phone":22,"phoneExt":22,"email":29},"Thierry GUILLAUME, MD",{"type":51,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[53],{"name":54,"class":55},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV","100376326","phase-1-phase-i-study-of-ctl-anti-dp-infusion-post-hematopoietic-stem-cell-transplantation-100376326",false,"NCT04180059","Phase I Study of CTL Anti-DP Infusion Post-hematopoietic Stem Cell Transplantation","A Phase 1 Dose-escalation Study Testing the Feasibility and the Tolerance of Infusion of a Specific Third Party Suicide Gene-transduced Anti-HLA-DPB1*0401 CD4+ T Cell Clone in HLA-DPB1*04:01 Positive Tumor Recipients Receiving an Allotransplant From a HLA-DPB1*04:01 Negative Donor.","CTL-DP 01","Inclusion Criteria:\n\n* Patients HLA-DPB1\\*04:01 positive, with confirmed diagnosis of hematologic malignancies (AML, Myelodysplasic and myeloproliferative syndrome, ALL, non-Hodgkin's lymphoma, Hodgkin's disease, CLL), undergoing an allo-HSCT using a HLA-DPB1\\*04:01 negative donor.\n* The graft can be PBSC (peripheric blood stem cells) or bone marrow.\n* Patients aged between 18-75 years.\n* Patients in complete remission or \\>50% of response (for lymphoma) at time of transplant.\n* have a donor with no contra-indications for mobilization of peripheral blood stem cells using G-CSF (colony-stimulating factors)\n* Affiliation number to the National Health Care System\n* Lack of reactivity of the clone against the donor's cells (PHA-blasts prepared for from PBMCs).\n* For cord blood transplants: cord blood must be HLA-DPB1\\*04:01 negative and the HLA compatibility (A, B, DR) between the cord blood and the recipient must be 4\u002F6, 5\u002F6 or 6\u002F6.\n* ECOG \\\u003C=2 or Karnofsky \\>60%\n* neutrophils ≥ 1 000 cells \u002Fμl and\u002For platelets ≥ 50 000 cells\u002Fμl (growth factor allowed)\n\nExclusion Criteria:\n\n* pregnant or breastfeeding woman\n* patient refusing contraception measure\n* minor\n* Adult patients under guardianship, curatorship or justice protection\n* Patients with post-transplant relapse within the clone injection time (before D100)\n* Karnofsky performance score below 60%or ECOG \\>2\n* Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease.\n* Severe liver failure (bilirubin \\>30 µmoles\u002FL, SGPT (Serum Glutamo-Oxalacetic Transaminase)\\> 4 X upper limit of normal).\n* Impaired renal function (creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Acute GVHD \\> grade 1\n* Active uncontrolled infection.\n* Denied to provide informed consent\n* Severe neurological or psychiatric disorders as determined by the study physician.\n* Treatment with other investigational drugs following allogeneic transplantation.","ALL","18 Years","75 Years",{"count":68,"type":69},6,"ESTIMATED","INTERVENTIONAL",[72],"PHASE1","For several decades, allogeneic hematopoietic stem cell trans-plantation (allo-HSCT) has remained an important strategy in the management of patients with high-risk hematological malignancies. The acceptance of umbilical cord blood (UCBT) and haploidentical grafts (Haplo) as viable alternative donors for allo-HSCT has increased the options for patients with no matched donors and now ensures that a donor can be identified for virtually all patients. Relapsed disease is a principal threat to these patients and affects 30-50% of them. The therapeutic options for these relapsing patients are diverse but remain largely ineffective in altering their long-term outcomes. Therefore, pre-emptive treatment post allo-HSCT is considered.\n\nMHC (major histocompatibility complex) class II molecules are a family of molecules normally found only on hematopoietic cells. cell-surface proteins are responsible for the regulation of the immune system in humans and are important in disease defense.\n\nThey are the major cause of organ transplant rejections. Different HLA-DPB1 alleles exist in the general population. HLA-DPB1\\*04:01 is the most frequent (70.5%) while HLA-DPB1\\*02:01 represents 32% and HLA-DPB1\\*03:01 20%. In allo-HSCT, the donor and the recipient may express different HLA-DPB1 molecules. HLA-DPB1 matching status has an impact on GVL (graft versus leukemia) and GVHD. In recipients of HSCT, a match for DPB1 is associated with a significantly increased risk of disease relapse, irrespective of the matching status of other HLA molecules.. Therefore, one could anticipate that a mismatched of HLA class II could induce a selective GVL reactivity without GVHD.\n\nHLA-DP-expressing B cell and myeloid malignancies can be recognized and lysed by HLA-DP-specific T cells. The majority of leukemic cells (Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Lymphoid Leukemia) express HLA-DP. A T cell clone recognizing specifically HLA-DPB1\\*0401 has been developed as a permanent cell line This clone has been demonstrated to be able to kill HLA-DPB1\\*0401 positive leukemic cells. In addition, this clone harbors a special suicide gene allowing the destruction of the clone in presence of a specific anti-viral drug named ganciclovir.\n\nWe hypothesize that infusion of a third party suicide gene-transduced T cell clone directed against HLA-DPB1\\*401 might protect against possible relapse of hematological malignancies.\n\nWe propose to inject iv escalating dose of a third party clone recognizing HLA-DPB1\\*04:01, 4 to 5 months following transplantation (when immunosuppressive drugs have been discontinued) in patients HLA-DPB1\\*04:01 positive with a donor HLA-DPB1\\*04:01 negative to evaluate the feasibility, toxicity, benefits of this immune intervention.",[75],"Haematologic Disease",[77,78,79,80,21],"hematopoietic stem cell transplantation","lymphocyte infusion","cytotoxic T lymphocyte","HLA-DP","2026-01-23",{"date":83,"type":84},"2026-01-26","ACTUAL",{"date":86,"type":84},"2020-02-09",{"date":88,"type":69},"2027-08",{"name":5,"class":6},1]