A Phase I/II Open-Label, Single-Arm, Multicenter Clinical Study of CM355 in Patients With R/R B-NHL
This is a phase I/II open-label, single-arm, multicenter study in China to evaluate the safety, tolerability, and efficacy of CM355 in patients with R/R B-NHL. In the study, patients will not be screened for CD20 expression, but they must have a diagnosis of B-NHL that is expected to express CD20. After enrollment, tumor samples will be collected for retrospective analysis of CD20 expression
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
184
1. Dose Escalation Phase CM355 will be taken by patients and will be treated follow the "3+3" dose escalation scheme 2. Expansion Phase CM355 will be taken by patients and will assess the efficacy of CM355 in patients with specific histopathological Non-Hodgkin's Lymphoma, and the safety of drug
Beijing university cancer hospital
Beijing, China
Dose-limiting toxicities (DLT)
Incidence, nature, and severity of dose-limiting toxicities.
Time frame: Up to 2 year
Recommended phase II dose (RP2D) and/or (maximum tolerated dose) MTD
To determine the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of CM355 in patients with R/R B-NHL.
Time frame: Up to 2 year
Objective response rate(ORR)
Objective response rate (ORR) as assessed by independent review committee (IRC)
Time frame: through study completion,an average of 5 year
The safety and tolerability of CM355
Incidence, nature, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0.
Time frame: through study completion,an average of 5 year
Peak Plasma Concentration (Cmax)
Dose Escalation peak plasma concentration (ng/mL)
Time frame: Every cycle (21 days), until the end of treatment
Area under the plasma concentration versus time curve (AUC)
Dose Escalation AUC(μg·h/mL)
Time frame: Every cycle (21 days), until the end of treatment
Peak time
Time of maximum observed plasma concentration (Tmax)
Time frame: Every cycle (21 days), until the end of treatment
T1/2
Terminal half-life of CM355
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Time frame: Every cycle (21 days), until the end of treatment
Clearanc (CL)
Total body clearance of the drug from plasma (CL) of CM355
Time frame: Every cycle (21 days), until the end of treatment
Anti-CM355 antibodies (ADAs)
Incidence of anti-CM355 antibodies (ADAs) and their correlation with clinical outcomes.
Time frame: Every cycle (21 days), until the end of treatment
Objective response rate (ORR)
Objective response rate (ORR) as assessed by investigators
Time frame: through study completion,an average of 5 year
Complete response rate (CRR)
Complete response rate (CRR) as assessed by investigators or independent review committee (IRC)
Time frame: through study completion,an average of 5 year
Duration of response (DOR)
Duration of response (DOR) as assessed by investigators or Independent review committee (IRC)
Time frame: through study completion,an average of 5 year
Progression-Free-Survival (PFS)
Progression-Free-Survival (PFS) as assessed by investigators or independent review committee (IRC)
Time frame: through study completion,an average of 5 year
overall survival (OS)
overall survival (OS) as assessed by investigators or independent review committee (IRC)
Time frame: through study completion,an average of 5 year