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
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BBM-A101, an AAV-based gene therapy, to treat people with moderate knee osteoarthritis. The study aims to assess the safety, tolerability, and effectiveness of this treatment. It is a Phase 1 clinical study with two parts: Phase Ia, which is randomized and single-blind, and Phase Ib, which is randomized and double-blind with parallel groups. Participants receive a single 2 ml injection of BBM-A101 directly into the knee joint. In Phase Ia, there are low, middle, and high dose groups along with a placebo group. In Phase Ib, participants are assigned to either low or high dose groups or a placebo group. The study compares these groups to evaluate the treatment effects and safety. During the study, participants undergo regular assessments including monitoring of adverse events and serious adverse events for up to one year. Researchers will also measure gene expression protein levels, virus shedding in various bodily fluids, changes in knee joint space by X-ray, and antibody responses over a period of up to five years. Participants are followed closely with lab tests, imaging, and clinical evaluations to track outcomes and safety throughout the study duration.
CONDITIONS
Brief 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 capsid in blood
- Experienced moderate pain with a WOMAC pain score of 8 or higher after prior conventional treatment
- Agree to use effective contraception from screening to 52 weeks post-treatment with no plans for sperm or egg donation
- Able and willing to sign informed consent and complete study requirements
You will not qualify if you...
- Possible secondary knee osteoarthritis or other causes of knee symptoms
- History of lumbar disc herniation with nerve symptoms affecting study assessment
- Unable or unwilling to have MRI or joint fluid extraction
- Significant lab abnormalities posing risk during trial
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infection
- Undergoing treatment for hepatitis B or C
- Recent chronic or active infections within 4 weeks
- Blood clotting disorders or conditions requiring anticoagulation making knee injection unsafe
- History of cancer or malignant tumors
- Previous or planned gene or stem cell therapy during study
- Recent vaccination within 30 days before or after dosing
- Pregnant, breastfeeding, or planning pregnancy within 52 weeks
- History of alcohol or drug dependence or inability to limit alcohol use
- 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
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 52 weeks
Participants receive a single-dose intra-articular injection of BBM-A101 or placebo for the treatment of knee osteoarthritis.
Multiple visits for safety and efficacy assessments during the 52 weeks post-treatment
Duration - Up to 5 years
Participants are monitored for long-term safety, gene expression, and joint health outcomes after treatment.
Periodic visits for long-term monitoring of protein levels, viral shedding, joint space changes, and antibody levels
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
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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