Gene therapy shot for arthritic knees enters human testing
NCT ID NCT07198555
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new gene therapy called BBM-A101 for people with moderate knee osteoarthritis. The main goal is to check if it is safe and tolerable. About 81 adults with knee pain and joint changes will receive the treatment and be monitored for side effects and any signs of improvement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 81 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shenzhen Second People's Hospital
RECRUITINGShenzhen, Guangdong, 518035, China
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The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200011, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a hydrogel injection ease knee arthritis pain?
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- Can shockwave plus injections quiet knee arthritis pain?