This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
186
intravenous infusion on day 1 once a week
Ruijin Hospital
Shanghai, China
RECRUITINGDose-limiting toxicity(DLT) and maximum tolerated dose(MTD)
Time frame: DLTs and MTD: Up to 28 days after the first dose
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: TEAEs: Up to 90 days after last dose
Overall response rate (ORR)
Defined as the proportion of participants with complete response or partial response measured by Lugano 2014
Time frame: Up to 12 months
Duration of response (DOR)
Defined as the time from complete response or partial response to progression disease or death
Time frame: Up to 12 months
Progression free survival (PFS)
Defined as the time from initiation of treatment to progression disease or death
Time frame: Up to 12 months
Overall survival (OS)
Defined as the time from initiation of treatment to death of any cause
Time frame: Up to 12 months
Aera under the curve from 0 to the last measurable concentration(AUClast)
Aera under the curve from 0 to the last measurable concentration
Time frame: Up to 12 months
Aera under the curve from 0 to the infinite time(AUC0-∞)
Aera under the curve from 0 to the infinite time
Time frame: Up to 12 months
Time to maximum concentration(Tmax)
time to maximum concentration
Time frame: Up to 12 months
Terminal phase half-life(T1/2)
terminal phase half-life
Time frame: Up to 12 months
Clearance(CL)
clearance
Time frame: Up to 12 months
Volume(Vd)
volume
Time frame: Up to 12 months
Maximum concentration( Cmax)
maximum concentration
Time frame: Up to 12 months
Minimum concentration(Cmin)
minimum concentration
Time frame: Up to 12 months
Accumulation ratio(AR)
accumulation ratio
Time frame: Up to 12 months
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