[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-rr-b-cell-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-rr-b-cell-malignancies":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":5},"100605748","phase-1-bispecific-car-t-cells-for-b-cell-malignancies-basecar-01-trial-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":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"B Cell Malignancies","B-cell Leukemia","B Cell Lymphoma","Bispecific Chimeric Antigen Receptor (CAR) T Cells","Relapsed or Refractory (r\u002Fr) B-cell Malignancies",[33,34,35,36,37,38,39,40,41,42,43,44,45],"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":49,"type":50},"2025-12-24","ACTUAL",{"date":52,"type":21},"2026-06",{"date":54,"type":21},"2028-11",{"name":56,"class":57},"University Hospital, Basel, Switzerland","OTHER"]