Actively Recruiting
A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
Led by Excyte Biopharma Ltd · Updated on 2026-02-05
70
Participants Needed
12
Research Sites
158 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 YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.
CONDITIONS
Official Title
A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or their legally acceptable representative must sign an informed consent form and agree to participate.
- Diagnosis of multiple myeloma according to IMWG criteria.
- Received at least two prior classes of drugs, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.
- Measurable disease at screening by serum M-protein ≥0.5 g/dL, urinary M-protein ≥200 mg/24 hours, or abnormal serum free light chain ratio with immunoglobulin FLC ≥10 mg/dL.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Estimated survival time greater than 12 weeks.
- Recovery to Grade 0-1 from prior therapy adverse events except alopecia.
- Adequate blood and organ function.
- Female participants of childbearing potential must have a negative pregnancy test and use effective contraception during and for 3 months after study treatment.
- Male participants must use reliable contraception or abstain from sperm donation during and for 3 months after study treatment.
You will not qualify if you...
- Plasma cell leukemia, Waldenstrom's Macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis.
- Recent antitumor therapy within specified washout periods including targeted therapy, chemotherapy, investigational drugs, or radiotherapy.
- Autologous stem cell transplantation within 12 weeks or allogeneic stem cell transplantation within 6 months.
- Prior treatment with BCMA-targeted therapies including CAR-T cells.
- Active acute or chronic graft-versus-host disease requiring systemic treatment.
- Prior myelodysplastic syndrome or other malignancies within 5 years except certain treated localized cancers.
- Active central nervous system involvement or metastases.
- Relevant CNS diseases or inflammatory brain lesions.
- Significant cardiovascular diseases including recent acute coronary syndromes, unstable arrhythmias, severe heart failure, abnormal heart function, prolonged QTc interval, implantable defibrillator, or uncontrolled hypertension.
- Known allergy to monoclonal antibodies or immunoglobulin.
- Recent major surgery or trauma not recovered before treatment.
- Recent systemic corticosteroid or immunosuppressive therapy.
- Active hepatitis B, hepatitis C, or HIV infection.
- Uncontrolled infections, pleural/pericardial effusion, or ascites requiring frequent drainage.
- Pregnant or lactating women.
- Mental disorders affecting compliance.
- Recent live attenuated or live virus vaccination.
- Other serious systemic diseases or lab abnormalities deemed inappropriate by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100024
Actively Recruiting
2
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100035
Actively Recruiting
3
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China, 528308
Actively Recruiting
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
5
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510289
Not Yet Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
7
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
9
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
Actively Recruiting
10
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
11
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 030013
Not Yet Recruiting
12
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
W
Wenming Chen, 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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