A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorExcyte Biopharma Ltd
About this trial
This study aims to provide a basis for further clinical development of YK012.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits.
Males or females aged ≥ 18 to ≤ 65 years.
Participants with an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1.
Participants with an estimated survival time of more than 12 weeks.
Disqualifiers
History of malignancy other than B-cell NHL within 5 years prior to study entry, except for local cancers that have been clearly cured or have been free of disease for at least 5 consecutive years.
Participants with clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the Investigator.
a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; b) Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI.
Known allergy to monoclonal antibody drugs or immunoglobulin.
Trial design
Design model
Sequential
Treatments tested in this trial
YK012
DrugYK012 is a bispecific antibody targeting CD19 on B cells and CD3 on T cells leading to T cell-mediated cytotoxicity of malignant B cells
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: YK012Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the first infusion of YK012 until 28 Days after end of treatment2
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 dose3
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 doseSecondary outcomes
1
Area under the concentration-time curve (AUC) after administration
Assess the AUC after treatment with YK012
Time frame
12 weeks2
Maximum concentration (Cmax) after administration
Assess the Cmax after treatment with YK012
Time frame
12 weeks3
Time to maximum concentration (Tmax) after administration
Assess the Tmax after treatment with YK012
Time frame
12 weeks4
Terminal elimination half-life (T1/2) after administration
Assess the terminal elimination half-life (T1/2) after treatment with YK012
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov