Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012
Led by Excyte Biopharma Ltd · Updated on 2026-02-05
48
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to provide a basis for further clinical development of YK012.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study procedures
- Male or female aged 18 to 65 years
- Eastern Cooperative Oncology Group (ECOG) performance score of 1 or less
- Estimated survival time longer than 12 weeks
- Diagnosis of relapsed or refractory B-cell non-Hodgkin lymphoma including specific subtypes
- Prior rituximab treatment unless intolerant, and at least second-line therapy
- At least one measurable tumor lesion per Lugano 2014 criteria
- Recovery from adverse reactions to previous treatments to below grade 1 (except hair loss)
- Essentially normal blood, liver, and kidney function
- Female participants of childbearing potential must have negative pregnancy test and use reliable contraception during the study and 3 months after last dose
- Male participants must use reliable contraception and avoid sperm donation during the study and 90 days after last dose
You will not qualify if you...
- Treatment with biologic targeted therapy or anti-tumor immunotherapy within 4 weeks before first YK012 dose
- Chemotherapy within 4 weeks before first YK012 dose
- Small molecule targeted agents within 2 weeks or 5 half-lives before first YK012 dose
- Other investigational agents within 4 weeks or 5 half-lives before first YK012 dose
- Radical/extensive radiotherapy within 4 weeks or local palliative radiotherapy within 2 weeks before first dose, or unresolved radiotherapy toxicity
- Autologous hematopoietic stem cell transplant within 12 weeks before first dose
- Allogeneic hematopoietic stem cell transplant or organ transplant
- Prior chimeric antigen receptor T cell immunotherapy
- History of other malignancies within 5 years except certain cured or disease-free local cancers
- Symptomatic or uncontrolled central nervous system metastases
- History or presence of serious CNS disorders or inflammatory brain lesions
- Serious cardiovascular diseases including recent coronary events, unstable arrhythmias, severe heart failure, significant valve abnormalities, low left ventricular ejection fraction, prolonged QT intervals, implantable defibrillator, or uncontrolled hypertension
- Allergy to monoclonal antibodies or immunoglobulin
- Major surgery or significant trauma within 4 weeks before first dose or need for elective surgery during study
- Use of systemic corticosteroids above certain doses or other immunosuppressive therapies within 4 weeks before study
- Clinically significant viral infections
- Active uncontrolled infections requiring systemic therapy
- Uncontrollable fluid accumulations such as pleural or abdominal effusion
- Pregnancy or lactation
- Mental disorders or poor compliance
- Use of live attenuated vaccines within 4 weeks before first dose
- Any other condition judged unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
Y
Yuankai Shi, 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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