[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605748":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":58,"collaborators":20,"id":60,"slug":20,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":96,"whyStopped":20,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Intervention: Bispecific anti-CD19, anti-CD20 CAR T cells","EXPERIMENTAL","Bispecific anti-CD19, anti-CD20 CAR T cells administration",[13],"Drug: Experimental Intervention",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Experimental Intervention","The study intervention includes:\n\n* Lymphapheresis\n* Lymphodepleting chemotherapy\n* CAR-T infusion\n\nLymphocytes will be collected from the patients by lymphapheresis to produce a personalized IMP, bispecific anti-CD19, anti-CD20 CAR T cells, which will be manufactured at the GMP facility of the University Hospital Basel.\n\nPatients receive a preparative lymphodepleting chemotherapy of intravenous cyclophosphamide and fludarabine from day -5 until day -3 (or Bendamustine on day -3 and day -2), before anti-CD19\u002F20 CAR T cells are infused (day 0 = day of infusion).\n\nParticipants will undergo lymphapheresis 2-8 weeks prior to CAR T cell infusion.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Andreas Holbro, Prof. Dr.","University Hospital Basel, Division of Hematology","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+41 61 556 56 47","andreas.holbro@usb.ch",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Jana van den Berg, Dr. med","Jana.VandenBerg@usb.ch",[35],{"facility":36,"status":20,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University Hospital Basel, Division of Hematology or Medical Oncology","Basel","Canton of Basel-City","4031","Switzerland",{"type":42,"coordinates":43},"Point",[44,45],7.57327,47.55839,{"lat":45,"lon":44},[48,50,51,54,56],{"name":23,"role":28,"phone":49,"phoneExt":20,"email":30},"0041 61 556 56 47",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"Jana van den Berg, Dr.","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":20,"phoneExt":20,"email":20},"Heinz Läubli, Prof. Dr.",{"name":57,"role":53,"phone":20,"phoneExt":20,"email":20},"Benjamin Kasenda, PD Dr. Dr.",{"type":59,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100605748",false,"NCT07166549","Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)","A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies","BaseCAR-01","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including:\n\n  * Acute B-lymphoblastic leukaemia\n  * Burkitt lymphoma\n  * Primary CNS lymphoma\n  * DLBCL or high-grade lymphoma of any subtype\n  * Primary mediastinal B cell lymphoma (including grey zone lymphoma)\n  * Mantle Cell lymphoma\n  * Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)\u002F small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma\u002Fleukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma\n* CD19 and\u002For CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry)\n* ECOG clinical performance status ≤2\n* Able to provide written informed consent.\n* Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as:\n\n  * Adequate hepatic function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 × (ULN) and serum bilirubin ≤2.0 × ULN (except in congenital hyperbilirubinemia, such as Gilbert syndrome, where direct bilirubin ≤3.0 × ULN is allowed)\n  * Adequate renal function: creatinine clearance ≥30 mL\u002Fmin\u002F1.73 m2\n  * Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation \\> 91% with room air.\n  * Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia\n  * Adequate bone marrow reserve (Hemoglobin ≥80 g\u002FL (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10\\^9\u002FL (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10\\^9\u002FL (prior growth factor support is permitted but must be without support in the 7 days before the laboratory test), Absolute Lymphocyte Count ≥0.3 ×10\\^9\u002FL)\n* Willingness to practice highly effective methods of birth control, and, in females of childbearing potential, negative urine or serum pregnancy test before study inclusion, lymphapheresis, and lymphodepleting chemotherapy.\n\nExclusion Criteria:\n\n* Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs\n* Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease.\n* Uncontrolled coronary artery disease or uncontrolled arrhythmias\n* Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status.\n* Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma).\n* Active secondary malignancy that progressed or required treatment in the last 24 months, other than basal or squamous cell carcinomas of the skin. Further allowed exceptions are: Non-muscle-invasive bladder cancer, non-invasive cervical cancer, or other malignancy that is considered cured or to have a minimal risk of recurrence (e.g. a history of localized prostate or localized and treated breast cancer).\n* Uncontrolled active bacterial, fungal, or viral infections, particularly active hepatitis B, hepatitis C, or HIV infection.\n* Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including previous severe reactions to dimethyl-sulfoxide\n* Cytotoxic chemotherapy within 14 days before apheresis collection for CAR-T cells, respectively 12 weeks for Bendamustin and Fludarabine, and 6 months for Alemtuzumab and ATG.\n* Cytotoxic chemotherapy (except for lymphodepletion) within 14 days of CAR-T cell infusion.\n* Patients who have undergone allogeneic hematopoietic stem cell transplantation less than 12 weeks ago, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n* Previous CAR-T cell therapy within 12 weeks of planned CAR-T cell infusion.\n* Investigational treatments within other trials ≤ 4 weeks before enrollment.\n* Lack of safe contraception; Women who are pregnant or breastfeeding; and men who plan to father a child while enrolled in this study within 1 year of receiving bispecific anti-CD20, anti-CD19 CAR T cells.","ALL","18 Years",{"count":70,"type":71},12,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma\u002Fleukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options.",[77,78,79,80,81],"B Cell Malignancies","B-cell Leukemia","B Cell Lymphoma","Bispecific Chimeric Antigen Receptor (CAR) T Cells","Relapsed or Refractory (r\u002Fr) B-cell Malignancies",[83,84,85,86,87,88,89,90,91,92,93,94,95],"Bispecific anti-CD19, anti-CD20 CAR T cell therapy","lymphapheresis","lymphodepleting (non- myeloablative) chemotherapy","Immune effector cell-associated neurotoxicity syndrome (ICANS)","Cytokine release syndrome (CRS)","Immune effector cell-associated haematotoxicity (ICAHT)","European Group for Blood and Marrow Transplantation (EBMT)","18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)","positron emission computed tomography (PET CT)","acute lymphocytic leukemia (ALL)","immunoglobulin heavy chain (IGH)","non-Hodgkin's lymphoma (NHL)","Eastern Cooperative Oncology Group (ECOG)","NOT_YET_RECRUITING","2025-12-17",{"date":99,"type":100},"2025-12-24","ACTUAL",{"date":102,"type":71},"2026-06",{"date":104,"type":71},"2028-11",{"name":5,"class":6},1]