This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.
ET019002-T cell therapy is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR-T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.The arm of the study is experimental i.v. arm:ET019002-T cells administered by intravenous (IV) infusion.The intervention is ET019002-T cells(Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET019002)-expression construct).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 0.75×10\*6/kg.
ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 1.5×10\*6/kg.
ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 3.0×10\*6/kg.
Maximum Tolerated Dose
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET019002T-cells,which is irreversible or life threatening or CTCAE Grade 3-5.
Time frame: Up to 12 weeks.
Tmax of serum cytokine levels
Cytokins as measured by CBA-Bioplex Multiplex Immunoassays will be presented as time to peak level.
Time frame: Up to 12 weeks.
Time to baseline for serum cytokine levels
Inceases or decreases in the amout of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing.
Time frame: Up to 12 weeks.
Toxicity profile of ET019002T-cell treatment
Frequency of treatment-related adverse events that occurred at any time from the first day of infusion that are "possibly", "likely", or "definitely" related to the study, including infusion related toxicity and ET019002 T cell related toxicity. Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
Time frame: Up to 2 years.
Rate of disease response
Rate of disease response assessed by lugano cliassification.Response rates will be estimated as CR,PR,SD,PD.
Time frame: Up to 12 weeks.
Progression free survival(PFS)
Progression free survival(PFS) denotes the chances of staying free of disease progression for patients after treatment.
Time frame: Up to 2 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to baseline for B cell level
B cell level as measured by Bio-Plex Multiplex Immunoassays will be presented.
Time frame: Up to 2 years.