Actively Recruiting
A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis.
Led by Belief BioMed (Beijing) Co., Ltd · Updated on 2025-11-18
81
Participants Needed
2
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-A101 to treat participants with knee osteoarthritis.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with moderate knee osteoarthritis.
- Kellgren-Lawrence grade 2 or 3 in the knee joint.
- Body Mass Index (BMI) between 18.0 and 35.0 kg/m2.
- Low antibody levels against BBM-A101 in the blood.
- Prior adequate treatment with conventional medications but persistent moderate knee pain with WOMAC pain score ≥ 8.
- Agree to use effective contraception and have no plans for sperm or egg donation from screening through 52 weeks after dosing.
- Voluntarily sign informed consent and able to comply with the study protocol.
You will not qualify if you...
- Possible secondary knee osteoarthritis or knee symptoms not caused by osteoarthritis.
- History of lumbar disc herniation with lower limb nerve symptoms affecting study assessment.
- Unable or unwilling to undergo MRI or have contraindications for MRI.
- Unable or unwilling to undergo joint fluid extraction.
- Clinically significant abnormal lab results before dosing posing risk.
- Positive for hepatitis B surface antigen or DNA, hepatitis C RNA, HIV antibody, or Treponema pallidum antibody.
- Currently treated for hepatitis B or C.
- Persistent chronic or active infections within the previous 4 weeks.
- Coagulation disorders or medical conditions requiring anticoagulation that prevent knee injection.
- Current or past cancer or malignant tumors.
- Prior or planned gene or stem cell therapy during the study period.
- Vaccination within 30 days before or planned within 30 days after dosing.
- Pregnant or breastfeeding women, positive pregnancy test, or planning pregnancy within 52 weeks.
- History of alcohol addiction, drug dependence, or inability to limit alcohol use during the study.
- Mental disorders affecting study assessment.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518035
Actively Recruiting
2
The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
W
Wenshu Luo, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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