Actively Recruiting
Study of YK012 in B-cell Acute Lymphoblastic Leukemia
Led by Excyte Biopharma Ltd · Updated on 2026-02-06
46
Participants Needed
12
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of YK012 in B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form (ICF) indicating understanding and willingness to participate
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2
- Estimated survival time longer than 12 weeks
- Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with specific relapse or treatment failure conditions
- At least 5% blasts in bone marrow by morphologic assessment
- Recovery to Grade 0-1 from prior therapy adverse events except alopecia
- Adequate hematological and organ function
- Negative pregnancy test for females of childbearing potential at screening
- Female participants must use effective contraception during the study and for 3 months after last dose
- Male participants must use reliable contraception or abstain during the study and for 3 months after last dose
You will not qualify if you...
- Diagnosis of Burkitt's Leukemia
- Recent targeted therapy, immunomodulatory therapy, radiotherapy, chemotherapy, investigational drug, live vaccines, or stem cell transplantation within specified time frames before first dose
- History of organ transplant or allogeneic stem cell transplantation within 12 weeks
- Active acute or chronic graft-versus-host disease requiring systemic treatment
- Other malignancies within 5 years except certain localized and treated cancers
- Active or uncontrolled central nervous system involvement or pathology
- History or evidence of significant cardiovascular disease including unstable arrhythmias, severe heart failure, low ejection fraction, prolonged QT interval, implantable defibrillator, or uncontrolled hypertension
- Known allergy to monoclonal antibodies or immunoglobulin
- Prior CD19 targeted therapy or positive immunogenicity test for YK012
- Recent major surgery or trauma with unresolved adverse events
- Use of systemic corticosteroids or immunosuppressive therapy within 4 weeks prior to study
- Positive hepatitis B or C virus tests or HIV infection
- Uncontrolled active infections requiring systemic therapy
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Pregnant or lactating women
- Known mental disorders affecting compliance
- Other serious diseases or lab abnormalities affecting study suitability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
4
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
5
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
6
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
7
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
8
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
9
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
Actively Recruiting
10
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Actively Recruiting
11
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650033
Actively Recruiting
12
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jie Jin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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