This is an open phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity, and preliminary efficacy of JS203 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. The study is divided into three phases: a dose-escalation phase, a dose-expansion phase, and an efficacy expansion phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
2-steps:JS203 for Injection is administered on the first and eighth day of the first cycle and every 3 weeks thereafter. 3-steps:JS203 for Injection is administered on the first, eighth and fifteenth day of the first cycle and every 3 weeks thereafter. 4-steps:JS203 for Injection is administered on the first, eighth, fifteenth and twenty-second day of the first cycle and every 3 weeks thereafter.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
MTD
It is suitable for dose escalation and dose extension.If the number of DLT patients is 0 and the next higher dose is unacceptable, the current dose is declared MTD.
Time frame: Throughout the dose escalation and dose expansion phases,, an average of 1.5 years
RP2D
It is suitable for dose escalation and dose extension.RP2D will be determined based on a combination of safety, tolerability, PK and/or pharmacodynamic studies .
Time frame: Throughout the dose escalation and dose expansion phases, an average of 1.5 years
DLT events
Incidence and severity of DLT events.
Time frame: Up to 2 years
Adverse events (AEs)
Incidence and severity of adverse events (AEs)
Time frame: Up to 2 years
Serious adverse events (SAEs)
Incidence and severity of serious adverse events (SAEs).
Time frame: Up to 2 years
abnormal changes in clinically significant laboratory tests and other examinations
abnormal changes in clinically significant laboratory tests and other examinations
Time frame: Up to 2 years
Objective Response Rate (ORR)
Objective Response Rate (ORR) as Assessed by Investigator according to Lugano 2014
Time frame: Up to 2 years
Complete Response (CR)
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Complete Response (CR) as Assessed by Investigator according to Lugano 2014
Time frame: Up to 2 years
Duration of Objective Response (DOR)
Duration of Objective Response (DOR) as Assessed by Investigator
Time frame: Up to 2 years
Duration of Complete Response (DOCR)
Duration of Complete Response (DOCR) as Assessed by Investigator
Time frame: Up to 2 years
Time to Response(TTR)
Time to Response(TTR) as Assessed by Investigator
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) as Determined by Investigator
Time frame: Up to 2 years
Overall Survival (OS)
Overall Survival (OS)
Time frame: Up to 2 years
Antidrug antibodies (ADA) and/or neutralizing antibodies (Nab)
incidence of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab)
Time frame: At pre-defined intervals up to 2 years
Total exposure(AUC) of JS203
Total exposure(AUC) of JS203
Time frame: At pre-defined intervals up to 2 years
Maximum Plasma Concentration (Cmax) of JS203
Maximum Plasma Concentration (Cmax) of JS203
Time frame: At pre-defined intervals up to 2 years
Half-life(T1/2) of JS203
Half-life(T1/2) of JS203
Time frame: At pre-defined intervals up to 2 years
Clearance(CL) of JS203
Clearance(CL) of JS203
Time frame: At pre-defined intervals up to 2 years
Volume of Distribution (Vss) of JS203
Volume of Distribution (Vss) of JS203
Time frame: At pre-defined intervals up to 2 years
Pharmacodynamic (PD) characteristics
CD20 receptor occupancy rate in peripheral blood cells
Time frame: At pre-defined interval up to 2 years
Pharmacodynamic (PD) characteristics
Changes in peripheral blood immune cell subtypes (B cells, T cells) before and after drug administration.
Time frame: At pre-defined interval up to 2 years
Pharmacodynamic (PD) characteristics
Changes in peripheral blood cytokines (IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ) before and after drug administration
Time frame: At pre-defined interval up to 2 years