Study of YK012 in B-cell Acute Lymphoblastic Leukemia
NCT Number: NCT06580301
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: B-cell Acute Lymphoblastic Leukemia
Interventions: DRUG: YK012
Sponsor: Excyte Biopharma Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2027-06-30
Locations: Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, 510000, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510000, China|Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China|The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, 550004, China|Henan Provincial People's Hospital, Zhengzhou, Henan, 450003, China|The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|The First Hospital of Jilin University, Changchun, Jilin, 130021, China|Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, 116001, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110000, China|The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650033, China|The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China

Summary:
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).

Primary Outcome Measures: 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 related to the IMP (Investigational Medicinal Product).

This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study., 28 days after the first dose|Maximum Tolerated dose (MTD) or The Recommended Dose for Future Clinical Study, This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study., Through study completion, 20 weeks|Number of Participants with Adverse Events, 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., From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.|Number of Participants with Serious Adverse Events, 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 IMP, and congenital abnormalities or birth defects., From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.|Dose Expansion Phase: Objective Response Rate (ORR), ORR is defined as percentage of participants achieving either a complete response (CR) or complete remission with partial hematological recovery (CRi).

The MTD dose will be calculated by the statistician upon completion of the dose escalation study.

This outcome measure is applicable for dose expansion phase only., From the time the participant signs the ICF until hematological relapse, assessed up to 1 year
Secondary Outcome Measures: Area Under the Concentration-time Curve (AUC), The PK (AUC) of YK012 will be evaluated., Up to 20 weeks|Maximum Observed Concentration (Cmax), The PK (Cmax) of YK012 will be evaluated., Up to 20 weeks|Time to Reach Maximum Concentration (Tmax), The PK (Tmax) of YK012 will be evaluated., Up to 20 weeks|Half Life (t1/2) of YK012, The PK (t1/2) of YK012 will be evaluated., Up to 20 weeks|Clearance (CL) of YK012, The PK (CL) of YK012 will be evaluated., Up to 20 weeks|Trough Plasma Concentration (Ctrough), The PK (Ctrough) of YK012 will be evaluated., Up to 20 weeks|Percentage of Participants with Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against YK012, Assess the percentage of participants with ADA and Nab (only assessed when ADA positive except for the screening period) after treatment with YK012., Up to 20 weeks|Dose Escalation Phase: Objective Response Rate (ORR), ORR is defined as percentage of participants achieving either a complete response (CR) or complete remission with partial hematological recovery (CRi).

The MTD dose will be calculated by the statistician upon completion of the dose escalation study.

This outcome measure is applicable for dose escalation phase only., From the time the participant signs the ICF until hematological relapse, assessed up to 1 year|Relapse-free Survival (RFS), RFS was measured from first dose of YK012 until the first assessment of documented relapse, or death due to any cause, whichever occurs first including the time after the transplant., From the time the participant signs the ICF until hematological relapse, assessed up to 1 year|Overall survival (OS), Overall survival was measured from the first treatment with YK012 until death due to any cause. Participants who did not die were censored at their last contact date., From the date of first dose until loss of follow-up, death, withdrawal of informed consent, or the end of study, whichever occurs first, assessed up to 1 year.|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, Up to 20 weeks