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.
Age ≥ 18 years
Acute B-lymphoblastic leukaemia
Burkitt lymphoma
Primary CNS lymphoma
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.
Single group
Experimental Intervention
DrugThe study intervention includes: * Lymphapheresis * Lymphodepleting chemotherapy * CAR-T infusion Lymphocytes 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. Patients 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-CD19/20 CAR T cells are infused (day 0 = day of infusion). Participants will undergo lymphapheresis 2-8 weeks prior to CAR T cell infusion.
Evaluation of Adverse Events
All adverse events will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the CTCAE Version v5.0.
Evaluation of Adverse Events of special interest (CRS)
All adverse events of special interest (CRS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the ASTCT CRS Consensus Grading (Grade 1 up to Grade 4; with Grade 4 as most severe CRS Grade)
Evaluation of Adverse Events of special interest (ICANS)
All adverse events of special interest (ICANS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the Immune-effector Cell-associated Encephalopathy (ICE) test, which was developed to provide objectivity for screening and grading the severity of ICANS. The ICE score is performed at least every 8 hours during in-patient care and at every outpatient visit. A higher score indicates better cognitive function, with a perfect score of 10 signifying no impairment.
Evaluation of Adverse Events of special interest (ICAHT)
Evaluation of Adverse Events of special interest (ICAHT) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the EHA/EBMT consensus grading. The EHA/EBMT consensus grading score is a classification system based on depth and duration of neutropenia.
Objective response rate (ORR): Change in metabolic response in FDG-PET/CT scan
For lymphomas and B-cell ALL with lymphadenopathy metabolic response in FDG-PET/CT scan according to the Lugano Classification (Response assessment: Complete Remission; Partial Remission; Progressive Disease)
Objective response rate (ORR): Change in minimal residual disease (MRD) negativity in blood
For patients with B-cell ALL minimal residual disease (MRD) negativity as determined by flow cytometry
Objective response rate (ORR): Change in minimal residual disease (MRD) negativity in bone marrow
For patients with B-cell ALL minimal residual disease (MRD) negativity as determined by flow cytometry
Objective response rate (ORR): Change in sustained MRD-negative Complete Remission (CR)
For patients with B-cell ALL: Sustained MRD-negative CR determined by polymerase chain reaction of the IgH rearrangement
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