Actively Recruiting
A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YKST02, a new medicine designed to activate the body's immune system to fight relapsed or refractory multiple myeloma, a cancer of plasma cells in the blood. This first-in-human study aims to assess the safety, tolerability, how the body processes the medicine, and its initial effectiveness in patients who have already undergone prior treatments. The study is sponsored by Excyte Biopharma Ltd and includes patients aged 18 to 75 years with measurable disease and prior therapies.
CONDITIONS
Brief Title
A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must sign informed consent and understand the study procedures.
- Diagnosed with multiple myeloma according to IMWG criteria.
- Have received at least two prior drug classes including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 drugs.
- Have measurable disease defined by serum M-protein ≥0.5 g/dL, urinary M-protein ≥200 mg/24h, or abnormal serum free light chain ratio and levels.
- ECOG 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 3 months after treatment.
- Male participants must use reliable contraception during and 3 months after treatment.
You will not qualify if you...
- Plasma cell leukemia, Waldenstrom's Macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis.
- Recent antitumor therapies including targeted drugs, chemotherapy, investigational drugs, or radiotherapy within specified time frames.
- Autologous stem cell transplant within 12 weeks or allogeneic transplant within 6 months.
- Prior BCMA-targeted therapy or CAR-T cells therapy.
- Active graft-versus-host disease requiring treatment.
- Prior myelodysplastic syndrome or malignancy within 5 years except certain treated localized cancers.
- Active central nervous system involvement or metastases.
- History of significant CNS or brain disorders.
- Significant cardiovascular disease or uncontrolled hypertension.
- Allergy to monoclonal antibodies or immunoglobulin.
- Recent major surgery or trauma.
- Use of systemic corticosteroids or immunosuppressive therapy within 4 weeks before study.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Uncontrolled infections or effusions.
- Pregnant or breastfeeding women.
- Mental disorders affecting compliance.
- Receipt of live vaccines within 4 weeks before study.
- Other serious diseases or lab abnormalities as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 42 weeks
Participants receive different doses of YKST02 via intravenous injection in 21-day cycles to evaluate safety, tolerability, and preliminary efficacy.
Repeated visits every 21 days for dosing and assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here