L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
L218CAR19 is intravenously administered at three dose levels.
Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGDose limiting toxicity (DLT)
Occurrence of DLTs
Time frame: Up to 4 weeks
Treatment-emergent adverse event (AE)
Incidence of treatment-emergent AEs
Time frame: Up to 1 year
Quantification of L218CAR19 in peripheral blood
To quantify L218CAR19 in a patient's peripheral blood at different time points
Time frame: Up to 1 year
Time to reach Cmax (Tmax) of L218CAR19
To identify the time point when the concentration of L218CAR19 reaches maximum in a patient's peripheral blood
Time frame: Up to 3 months
Area under the curve (AUC) of L218CAR19
To quantify the cumulative amount of L218CAR19 in a patient's peripheral blood over time
Time frame: Up to 3 months
Clearance (CL) of L218CAR19
To determine the clearance factor of L218CAR19 in a patient's peripheral blood
Time frame: Up to 3 months
Immunogenic response to L218CAR19
To evaluate the anti-drug antibodies in response to L218CAR19 administration in a patient's peripheral blood
Time frame: Up to 1 year
Serum cytokine concentrations
To measure the cytokine levels (e.g. TNFa, IL-6, IL-1, IL-2, etc.) in a patient's peripheral blood at different time points
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 3 months
ORR
To determine the overall (best) objective anti-cancer response by Lugano criteria
Time frame: Up to 1 year
PFS
To evaluate the duration of patient's progression-free survival
Time frame: Up to 1 year
OS
To evaluate the overall duration of patient's survival
Time frame: Up to 1 year