This study aims to provide a basis for further clinical development of YK012.
This study is the first-in-human clinical trial to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of YK012 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
YK012 is a bispecific antibody targeting CD19 on B cells and CD3 on T cells leading to T cell-mediated cytotoxicity of malignant B cells
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGIncidence of subjects with adverse events (AEs) and/or serious adverse events (SAEs)
An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug. An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the investigational drug, and congenital abnormalities or birth defects.
Time frame: From the first infusion of YK012 until 28 Days after end of treatment
The incidence and profile of dose-limiting toxicity (DLT)
The toxicities occurring within 28 days (i.e., DLT observation period) after the first dose will be defined as DLTs in the discretion of the investigator as possibly, probably, or definitely related to the IMP (Investigational Medicinal Product).
Time frame: 28 days after the first dose
The maximum tolerated dose and/or the recommended dose for further clinical trial
The MTD will be determined based on the occurrence rate of the DLT. The MTD is defined as the highest dose in which 1/6 or less subjects experience a DLT.
Time frame: 28 days after the first dose
Area under the concentration-time curve (AUC) after administration
Assess the AUC after treatment with YK012
Time frame: 12 weeks
Maximum concentration (Cmax) after administration
Assess the Cmax after treatment with YK012
Time frame: 12 weeks
Time to maximum concentration (Tmax) after administration
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Assess the Tmax after treatment with YK012
Time frame: 12 weeks
Terminal elimination half-life (T1/2) after administration
Assess the terminal elimination half-life (T1/2) after treatment with YK012
Time frame: 12 weeks
Percentage of participants with anti-drug antibodies (ADA)
Assess the percentage of participants with ADA after treatment with YK012
Time frame: 24 weeks
Tumor objective response rate (ORR)
Assess the overall response rate (ORR) after treatment with YK012
Time frame: 24 weeks
Duration of response (DOR)
Assess the duration of response (DOR) after treatment with YK012
Time frame: 24 weeks
Anti-lymphoma activity by progression-free survival (PFS)
Assess the progression-free survival (PFS) after treatment with YK012
Time frame: 24 weeks
Number of B cells and T cells in peripheral blood after administration
Assess the number of B cells and T cells in peripheral blood after treatment with YK012
Time frame: 12 weeks
Level of cytokines in peripheral blood after administration
The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interferon gamma (IFN-ɣ), interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, IL-12 and tumor necrosis factor-alpha (TNF-α) .
Time frame: 12 weeks