NCT07166549Not yet recruiting

Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)

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 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.

Inclusion criteria

• 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 criteria

• 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.

Contacts

The trial team's contact details are shown on request.

See the official trial record

Status: Not yet recruiting
Phase: Phase 1
Study type: Interventional
Countries: Switzerland
Sponsor: University Hospital, Basel, Switzerland(Other)
Protocol no.: 2025-01562, th23Holbro
Conditions: B Cell Malignancies, B-cell Leukemia, B Cell Lymphoma, Bispecific Chimeric Antigen Receptor (CAR) T Cells, Relapsed or Refractory (r/r) B-cell Malignancies
Interventions: Drug

Treatments studied

Experimental Intervention

Locations · 1

Basel, SwitzerlandUniversity Hospital Basel, Division of Hematology or Medical OncologyNot yet recruiting at this site

In total, worldwide, the only site listed in the registry is planned; recruitment has not opened yet.

Site status per the ClinicalTrials.gov registry (last update posted: December 24, 2025).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

2025 · NIH grant

Other versions

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