BBM-A101 gene therapy for moderate knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BBM-A101 is an AAV-based gene therapy delivered directly into the affected knee to deliver a therapeutic gene cassette aimed at relieving symptoms of moderate knee osteoarthritis. The phase 1 program includes Phase Ia (randomized, single-blind) and Phase Ib (randomized, double-blind, parallel) cohorts comparing BBM-A101 to placebo to measure safety, tolerability, and early signs of efficacy. Key entry criteria include Kellgren-Lawrence grade 2–3 disease, BMI 18–35 kg/m², low anti-capsid antibody titers, and a baseline WOMAC pain score ≥ 8. Participants are followed for safety and clinical outcomes through 52 weeks after dosing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants with moderate knee osteoarthritis .
2. The knee joint was evaluated as having Kellgren-Lawrence grade 2 or 3.
3. The Body Mass Index (BMI) ranges from 18.0 to 35.0 kg/m2 (including the boundary values).
4. Lower titers of antibodies binding to the BBM-A101 capsid in the blood.
5. Participants who had received adequate treatment with conventional medications previously, experienced recurrence or aggravation of target knee arthritis after discontinuation of medication, and still had moderate pain; during the screening period, the WOMAC pain score of the target knee was ≥ 8 .
6. From the time of screening to 52 weeks after dosing , the participants had no intention of having children and voluntarily took effective contraceptive measures, and there were no plans for sperm donation or ova donation.
7. Voluntarily sign the informed consent form and be able to complete the research as required by the clinical trial protocol.

   \-

Exclusion Criteria:

1. There is a possibility of secondary knee osteoarthritis, or the knee joint symptoms may not be caused by knee osteoarthritis, or there may be other medical histories of diseases that other researchers believe could potentially lead to knee osteoarthritic inflammation.
2. History of lumbar dischernaiation, accompanied by lower limb nerve symptoms that may affect the assessment of the study.
3. Participants who are unable or unwilling to undergo MRI examination, or who have contraindications to MRI.
4. Participants who are unable or unwilling to undergo joint fluid extraction.
5. During the screening period and before dosing, there were clinically significant abnormal values in the laboratory tests, and the researchers believed that these might pose risks to the participants in the clinical trial.
6. Those with positive results for hepatitis B virus surface antigen or hepatitis B virus deoxyribonucleic acid or hepatitis C virus ribonucleic acid test or human immunodeficiency virus antibody or Treponema pallidum antibody.
7. Currently undergoing treatment for hepatitis B and hepatitis C.
8. Participants who had persistent chronic or active infections within the previous 4 weeks were selected.
9. Participants who had coagulation disorders (such as hemophilia) or existing medical conditions that require anticoagulation therapy and make knee joint injection impossible.
10. Having or having had cancer or malignant tumors
11. Having received genetic therapy or stem cell therapy before screening or having plans for genetic therapy or stem cell therapy during the study period.
12. Any history of vaccination within 30 days prior to dosing or any vaccination schedule within 30 days after dosing.
13. Screening will be conducted on female participants who are pregnant or breastfeeding or whose HCG test result is positive; or who have plans to get pregnant within the next 52 w.
14. History of alcohol addiction or drug dependence, or inability to limit alcohol consumption during the research process.
15. Participants had any mental disorders that might affect the assessment of the study.
16. Having other conditions that the investigator consider unsuitable for participation in the study.

    \-

Where it's running

• Shenzhen Second People's Hospital
  Shenzhen, Guangdong, China Recruiting
• The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jie Zhao — The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
• Study coordinator: Wenshu Luo, Ph.D
• Email: luowenshu@beliefbiomed.com
• Phone: 021-33588288

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of virtual reality on walking in adults with knee osteoarthritis

  This study tests how immersive virtual reality environments—designed to feel safe or to provoke fear—affect walking and worry about movement in adults 50 and older with knee osteoarthritis and in healthy peers.

  Recruiting University of Primorska · Vilnius and 1 other locations · NCT07920120

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Autologous adipose-derived stem cell injections for knee osteoarthritis

  We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.

  Recruiting at 3 sites Yonsei University · Incheon and 2 other locations · NCT07901790

• Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty

  This study tests whether higher burden of preoperative multimorbidity affects functional recovery after knee replacement in adults with knee osteoarthritis.

  Recruiting Balikesir Ataturk City Hospital · Balıkesir · NCT07882316

• Cartilage biomarker response to acute loading in knee OA by antiresorptive treatment status

  Researchers will test whether a 30-minute treadmill walk changes cartilage biomarkers in postmenopausal women with knee osteoarthritis, comparing those on denosumab, bisphosphonates, and those not on antiresorptives.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Istanbul, Istanbul · NCT07881861

• Lysyl Enzymes in Knee Osteoarthritis

  This study tests whether blood levels of lysyl hydroxylase and lysyl oxidase differ between people with knee osteoarthritis and healthy individuals.

  Recruiting Afyonkarahisar Health Sciences University · Afyonkarahisar · NCT07875296

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.