A Study of YKST02 in Participants with Relapsed or Refractory Multiple Myeloma
NCT Number: NCT06574568
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Excyte Biopharma Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2027-06-30

Summary:
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.

Primary Outcome Measures: 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., 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., 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., up to 42 weeks|Overall Response Rate (ORR), Measured by IMWG criteria, only applicable in dose expansion phase, From the date of dosing until the date of first documented progression
Secondary Outcome Measures: Area under the Concentration-time Curve (AUC) after Administration, AUC of YKST02, up to 42 weeks|Maximum Serum Concentration (Cmax) of YKST02, Cmax is defined as the maximum observed serum concentration of YKST02, up to 42 weeks|Time to Cmax of YKST02 (Tmax), Time to maximum serum concentration (Tmax) of YKST02, up to 42 weeks|Terminal Half-life (T1/2) of YKST02, Terminal Half-life (T1/2) of YKST02, 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., up to 42 weeks|ORR, Measured by IMWG criteria, only applicable in dose escalation phase, 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, 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., 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., From start of treatment to end of the study (approximately 42 weeks)