Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Intravenous Infusion
Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Incidence and Characteristics of SAE
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
dose limited toxicity(DLT), maximum tolerance dose(MTD)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Peak Plasma Concentration(Cmax)
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Area under the plasma concentration versus time curve(AUC)
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
time to peak (Tmax)
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
half-life time(T1/2)
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
clearance(CL)
Time frame: At the end of Cycle3 (each cycle is 28 days)
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Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
volume of distribution(Vz)
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
B-cell level
Time frame: At the end of Cycle3 (each cycle is 28 days)