Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20\^7 transduced cells/m\^2) after lymphodepletion with fludarabine and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Dose Level 1: 1×10\^6 transduced cells/m\^2; Dose Level 2: 5×10\^6 transduced cells/m\^2; Dose Level 3: 20×10\^6 transduced cells/m\^2; Dose Level 4: 5x10\^7 transduced cells/m\^2; Dose Level 5: 10x10\^7 transduced cells/m\^2; Dose Level 6: 20x10\^7 transduced cells/m\^2
3 days of fludarabine 30 mg/m\^2/day
3 days of cyclophosphamide 500 mg/m\^2/day
University Hospital Heidelberg
Heidelberg, Germany
RECRUITINGUniversity Hospital Heidelberg
Heidelberg, Germany
RECRUITINGSafety of CD19.CAR T cell administration assessing grade and frequency of toxicities including cytokine release syndrome (CRS) and neurotoxicity according to Common Toxicity Criteria for Adverse Events (CTCAE)
Time frame: Up to 90 days after CD19.CAR T cell administration
Feasibility of CD19.CAR T cell manufacturing assessing the number of transduced T cells
Time frame: Within 45 days prior to CD19.CAR T cell administration
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