[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601313":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":63,"collaborators":20,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":20,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose finding","EXPERIMENTAL","Phase I dose finding and efficacy study using the 3+3 design",[13],"Biological: CAR-T cells targeting CD19 and CD22",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CAR-T cells targeting CD19 and CD22","Using the 3+3 design, the following dose levels will be assessed:\n\nDose level 1: 0.5x10e6 CAR-transduced T cells\u002Fkg; Dose level 2: 1x10e6 CAR-transduced T cells\u002Fkg; Dose level 3: 2x10e6 CAR-transduced T cells\u002Fkg; Dose level 0: 0.25x10e6 CAR-transduced T cells\u002Fkg",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Wolfgang Bethge, Prof. Dr.","CONTACT","+49 7071 29-83176","Wolfgang.Bethge@med.uni-tuebingen.de",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Peter Lang, Prof. Dr.","+49 7071 29-80894","Peter.Lang@med.uni-tuebingen.de",[32,52],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University Hospital , Department of Internal Medicine II","RECRUITING","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],9.05222,48.52266,{"lat":44,"lon":43},[47,48],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":49,"role":24,"phone":50,"phoneExt":20,"email":51},"Christoph Faul, Dr.","+49 7071 29-84087","Christoph.Faul@med.uni-tuebingen.de",{"facility":53,"status":54,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"University Hospital, Clinic for Pediatric Medicine","NOT_YET_RECRUITING",{"type":41,"coordinates":56},[43,44],{"lat":44,"lon":43},[59,60],{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"name":61,"role":24,"phone":29,"phoneExt":20,"email":62},"Tim Flaadt, Dr.","Tim.Flaadt@med.uni-tuebingen.de",{"type":64,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100601313","phase-1-a-phase-i-dose-finding-study-of-mb-cart22191-100601313",false,"NCT07108868","A Phase I Dose Finding Study of MB-CART2219.1","A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19\u002FCD22 in Adult and Pediatric Patients With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. For Cohort II ALL, pediatrics: Subject is ≥ 12 years of age at the time of signing ICF.\n3. Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures.\n4. Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.\n5. CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available.\n6. Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure.\n7. All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment.\n8. Male or female patients must have relapsed refractory (r\u002Fr) CD19 or CD22 -expressing ALL or Lymphoma\u002FCLL and meet the following disease-specific criteria.\n\n   1. Patients with r\u002Fr lymphoma with following entities according to 5th edition of the WHO Classification of Haematolymphoid Tumors after two or more systemic therapies, including one approved in label CAR-T-cell or bispecific antibody treatment option or with contraindications for such treatments:\n\n      * B-lymphoblastic lymphomas\n      * B-Chronic lymphocytic leukemia\n      * Splenic B-cell lymphoma\n      * Marginal zone lymphoma\n      * Follicular lymphoma\n      * Mantle cell lymphoma\n      * Large B-cell lymphoma\n      * Burkitt lymphoma\n      * Transformation from indolent lymphoma\n   2. Patients with r\u002Fr CLL after established and approved treatment options including therapy with BTK inhibitors have failed\n   3. Patients with lymphoma recommended for autologous or allogeneic stem cell transplant (SCT) therapy by interdisciplinary boards, but not consenting or ineligible for this treatment (including patients with refractory disease precluding allo SCT at this time, which can be included in the study as bridge to allo SCT)\n   4. Patients with lymphoma relapse after SCT, or afterCD19 or CD22 targeting therapies and with confirmed either CD19 or CD22 expression after relapse\n   5. Patients with CNS involvement by lymphoma are eligible if disease is successfully controlled at the time of inclusion\n\nExclusion Criteria:\n\n1. Subject received any of the following within the last 7 days of leukapheresis:\n\n   * Any investigational agent\n   * Immunsupressive medication\n   * Plasmapheresis\n   * Major surgery (as defined by the investigator)\n   * Radiation therapy other than local therapy for underlying malignancy\n   * Use of any systemic anti-neoplastic drug therapy or immune suppressive medication applied for graft versus-host-disease or other, including the use of high dose steroids e.g. \\>0,5 mg\u002Fkg BW methylprednisolone other than hydrocortisone replacement and other than intermittent topical, inhaled or intranasal corticosteroids which are allowed\n2. Subject has ECOG \\> 3 at screening for inclusion in the trial\n3. Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease\n4. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n5. Subject has any of the following laboratory abnormalities:\n\n   * Absolute neutrophil count (ANC) \\\u003C 500\u002FμL\n   * Absolute lymphocyte count \\\u003C 200\u002FµL at time of leukapheresis\n   * Platelet count \\\u003C 50,000 mm3 (platelet transfusion allowed)\n   * Serum Creatinine Clearance (CrCl) \\\u003C 45 mL\u002Fmin\n   * Corrected serum calcium \\> 13.5 mg\u002FdL (\\> 3.4 mmol\u002FL)\n   * Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)\n   * Serum total bilirubin \\> 1.5 × ULN or \\> 3.0 mg\u002FdL for subjects with documented Gilbert's syndrome\n   * International ratio (INR) or partial thromboplastin time (PTT) \\> 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)\n6. Patient has no adequate vascular access for leukapheresis\n7. Echocardiogram (ECHO) or multi-gated acquisition (MUGA) with left ventricular ejection fraction \\\u003C 45%\n8. Patient with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 3 months prior to starting study treatment\n9. Inadequate pulmonary function defined as oxygen saturation (Sa02) \\\u003C 90 % on room air\n10. Subject has history of primary immunodeficiency\n11. Subject is positive for human immunodeficiency virus (HIV-1), uncontrolled hepatitis B or C or active hepatitis A\n12. Subject with ongoing (incl. controlled) infections or infestations where inclusion of the patient into the clinical trials may significantly jeopardize the health and wellbeing of the patient, as determined by the investigator.\n13. Subject with malignancy other than the underlying malignancy in this protocol, unless this disease has been controlled for ≥ 1 year and the exception of the following noninvasive malignancies:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \\[tumor, nodes, metastasis\\] clinical staging system) or prostate cancer that is curative\n14. Patient is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during participation in the study\n15. Patient with known hypersensitivity to any component of MB-CART2219.1 product, cyclophosphamide, fludarabine, and\u002For tocilizumab\n16. Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study\n17. Patient has any further condition including the presence of further laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study","ALL","12 Years","75 Years",{"count":76,"type":77},36,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","A Phase I dose finding study of MB-CART2219.1 targeting CD19\u002FCD22 in adult and pediatric patients with relapsed\u002Frefractory B-cell malignancies",[83,84,85],"Lymphoma","CLL","Acute Lymphoblastic Leukemia, Pediatric",[87,88,89],"MB-CART2219.1 targeting CD19\u002FCD22","CD19\u002FCD22","CAR-T cells","2025-08-04",{"date":92,"type":93},"2025-08-07","ACTUAL",{"date":95,"type":93},"2025-06-23",{"date":97,"type":77},"2027-06",{"name":5,"class":6},2]