A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012
NCT Number: NCT06565689
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Interventions: DRUG: YK012
Sponsor: Excyte Biopharma Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-09
Completion Date: 2026-12-31
Locations: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China

Summary:
This study aims to provide a basis for further clinical development of YK012.

Primary Outcome Measures: Incidence 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., 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)., 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., 28 days after the first dose
Secondary Outcome Measures: Area under the concentration-time curve (AUC) after administration, Assess the AUC after treatment with YK012, 12 weeks|Maximum concentration (Cmax) after administration, Assess the Cmax after treatment with YK012, 12 weeks|Time to maximum concentration (Tmax) after administration, Assess the Tmax after treatment with YK012, 12 weeks|Terminal elimination half-life (T1/2) after administration, Assess the terminal elimination half-life (T1/2) after treatment with YK012, 12 weeks|Percentage of participants with anti-drug antibodies (ADA), Assess the percentage of participants with ADA after treatment with YK012, 24 weeks|Tumor objective response rate (ORR), Assess the overall response rate (ORR) after treatment with YK012, 24 weeks|Duration of response (DOR), Assess the duration of response (DOR) after treatment with YK012, 24 weeks|Anti-lymphoma activity by progression-free survival (PFS), Assess the progression-free survival (PFS) after treatment with YK012, 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, 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) ., 12 weeks