This study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.
This study is the first-in-human clinical trial to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of YKST02 in patients with relapsed or refractory multiple myeloma (MM). Multiple Myeloma (MM) is a cancer of the blood's plasma cells (blood cell). YKST02 is a bispecific antibody bridging CD3-expressing T cells and BCMA-expressing multiple myeloma cells to induce T cells-mediated cytotoxicity. This study consists of dose escalation phase and dose expansion phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
BCMA-CD3 bispecific antibody
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Number of Participants with Dose-limiting Toxicities (DLT)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Time frame: 21 days after the first dose
Incidence of Adverse Events (AEs)
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.
Time frame: up to 42 weeks
Incidence of Serious Adverse Events (SAEs)
A 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: up to 42 weeks
Overall Response Rate (ORR)
Measured by IMWG criteria, only applicable in dose expansion phase
Time frame: From the date of dosing until the date of first documented progression
Area under the Concentration-time Curve (AUC) after Administration
AUC of YKST02
Time frame: up to 42 weeks
Maximum Serum Concentration (Cmax) of YKST02
Cmax is defined as the maximum observed serum concentration of YKST02
Time frame: up to 42 weeks
Time to Cmax of YKST02 (Tmax)
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Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGAffiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
NOT_YET_RECRUITING...and 2 more locations
Time to maximum serum concentration (Tmax) of YKST02
Time frame: up to 42 weeks
Terminal Half-life (T1/2) of YKST02
Terminal Half-life (T1/2) of YKST02
Time frame: up to 42 weeks
Percentage of Participants with Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against YKST02
Assess the percentage of participants with ADA and Nab (only assessed when ADA positive) after treatment with YKST02.
Time frame: up to 42 weeks
ORR
Measured by IMWG criteria, only applicable in dose escalation phase
Time frame: From the date of dosing until the date of first documented progression
Progression-free Survival (PFS)
Evaluation of the efficacy of YKST02 in patients with MM on progression-free survival
Time frame: From the date of dosing until the date of first documented progression
Overall survival (OS)
Overall survival (OS) was defined as the time from the date of first dose until death due to any cause.
Time frame: From the date of first dose until loss of follow-up, death, withdrawal of informed consent, or the end of study, whichever occurs first
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate was the percentage of participants with CR/sCR and negative MRD.
Time frame: From start of treatment to end of the study (approximately 42 weeks)