Status:
NOT_YET_RECRUITING
Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
B Cell Malignancies
B-cell Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The ...
Detailed Description
Chimeric antigen receptor (CAR) T cells are engineered T-lymphocytes with artificial receptors, containing domains of a T cell receptor as well as a B cell receptor with predefined specificity to a ta...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- 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:
- Acute B-lymphoblastic leukaemia
- Burkitt lymphoma
- Primary CNS lymphoma
- DLBCL or high-grade lymphoma of any subtype
- Primary mediastinal B cell lymphoma (including grey zone lymphoma)
- Mantle Cell lymphoma
- Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma/leukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma
- CD19 and/or CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry)
- ECOG clinical performance status ≤2
- Able to provide written informed consent.
- Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as:
- 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)
- Adequate renal function: creatinine clearance ≥30 mL/min/1.73 m2
- Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation \> 91% with room air.
- Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia
- Adequate bone marrow reserve (Hemoglobin ≥80 g/L (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10\^9/L (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10\^9/L (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/L)
- 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.
Exclusion
- Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs
- Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease.
- Uncontrolled coronary artery disease or uncontrolled arrhythmias
- Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status.
- Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma).
- 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).
- Uncontrolled active bacterial, fungal, or viral infections, particularly active hepatitis B, hepatitis C, or HIV infection.
- Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including previous severe reactions to dimethyl-sulfoxide
- 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.
- Cytotoxic chemotherapy (except for lymphodepletion) within 14 days of CAR-T cell infusion.
- 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.
- Previous CAR-T cell therapy within 12 weeks of planned CAR-T cell infusion.
- Investigational treatments within other trials ≤ 4 weeks before enrollment.
- 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.
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07166549
Start Date
June 1 2026
End Date
November 1 2028
Last Update
December 24 2025
Active Locations (1)
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1
University Hospital Basel, Division of Hematology or Medical Oncology
Basel, Canton of Basel-City, Switzerland, 4031