Knee OsteoarthritisPhase 1NCT07198555
A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis.
A Phase 1 study testing BBM-A101 in people with Knee Osteoarthritis, run by Belief BioMed (Beijing) Co., Ltd at 2 sites in China.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-A101 to treat participants with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- BBM-A101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 2 sitesChina
- Study dates
- 9 Oct 2025to 30 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with moderate knee osteoarthritis .
- The knee joint was evaluated as having Kellgren-Lawrence grade 2 or 3.
- The Body Mass Index (BMI) ranges from 18.0 to 35.0 kg/m2 (including the boundary values).
- Lower titers of antibodies binding to the BBM-A101 capsid in the blood.
- 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 .
- 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.
- Voluntarily sign the informed consent form and be able to complete the research as required by the clinical trial protocol.
- -
Who cannot join
- 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.
- History of lumbar dischernaiation, accompanied by lower limb nerve symptoms that may affect the assessment of the study.
- Participants who are unable or unwilling to undergo MRI examination, or who have contraindications to MRI.
- Participants who are unable or unwilling to undergo joint fluid extraction.
- 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.
- 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.
Show all 17Show fewer
- Currently undergoing treatment for hepatitis B and hepatitis C.
- Participants who had persistent chronic or active infections within the previous 4 weeks were selected.
- Participants who had coagulation disorders (such as hemophilia) or existing medical conditions that require anticoagulation therapy and make knee joint injection impossible.
- Having or having had cancer or malignant tumors
- Having received genetic therapy or stem cell therapy before screening or having plans for genetic therapy or stem cell therapy during the study period.
- Any history of vaccination within 30 days prior to dosing or any vaccination schedule within 30 days after dosing.
- 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.
- History of alcohol addiction or drug dependence, or inability to limit alcohol consumption during the research process.
- Participants had any mental disorders that might affect the assessment of the study.
- Having other conditions that the investigator consider unsuitable for participation in the study.
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Jie Zhao, MD, 021-23271699, 13301815365@189.cn
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Wei Sun, MD, 13699750000, 414464705@qq.com
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis .
The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-A101 to treat participants with knee osteoarthritis.
Read the detailed description
This study is divided into two phases: Phase Ia and Phase Ib . Phase Ia is a randomized, single-blind study . Phase Ib is a randomized, double blind, parallel assignment study.
BBM-A101 is an AAVbased gene therapy that delivers a therapeutic gene cassette into knee for the treatment of knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- BBM-A101, Placebo
- Keywords
- knee osteoarthritis, gene therapy, Adeno-Associated Virus
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBM-A101Drug
Single-dose intra-articular （IA）injection （2ml）(phase Ia)
Low dose group， Middle dose group； High dose group； Control group ：Placebo
PlaceboDrug
Placebo(phase Ia)
BBM-A101Drug
Single-dose intra-articular （IA）injection （2ml）(phase Ib) Low dose group， High dose group
Control group ：Placebo
PlaceboDrug
Placebo（phase Ib）
| Study group | Role | What they receive |
|---|---|---|
| Arm of Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm of BBM-A101 | Experimental | Not described Receives: Drug: BBM-A101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT) events
Measured: within 4 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety of BBM-A101 by AEs and SAEs.
Measured: within 52 weeks
Secondary outcomes (5)
The protein levels of gene expression products in blood and joint fluid
Measured: within5 years
The shedding of recombinant adeno-associated virus (rAAV) vectors in peripheral blood, joint fluid, urine, feces, saliva, and semen
Measured: within 5 years
The change in the joint space width as detected by X-ray of the knee joint compared to the baseline
Measured: within 5 years
The changes in the titers of AAV capsid-binding antibodies in the blood and joint fluid compared to the baseline level
Measured: within 5 years
The changes in the titers of antibodies binding to the expressed products in the blood and joint fluid compared to the baseline level
Measured: within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start9 Oct 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belief BioMed (Beijing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Zhao, Principal investigator, The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198555
- Sponsor's protocol ID
- BBM007-CLN1001
- Status last verified
- Nov 2025
- First submitted
- 19 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis .
- ClinicalTrials.gov ID
- NCT07198555
- Acronym / sponsor ID
- BBM007-CLN1001
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, gene therapy, Adeno-Associated Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Belief BioMed (Beijing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-A101 to treat participants with knee osteoarthritis.
Detailed description
This study is divided into two phases: Phase Ia and Phase Ib . Phase Ia is a randomized, single-blind study . Phase Ib is a randomized, double blind, parallel assignment study.
BBM-A101 is an AAVbased gene therapy that delivers a therapeutic gene cassette into knee for the treatment of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm of Placebo | Placebo comparator | Drug: Placebo |
| Arm of BBM-A101 | Experimental | Drug: BBM-A101 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with moderate knee osteoarthritis .
- The knee joint was evaluated as having Kellgren-Lawrence grade 2 or 3.
- The Body Mass Index (BMI) ranges from 18.0 to 35.0 kg/m2 (including the boundary values).
- Lower titers of antibodies binding to the BBM-A101 capsid in the blood.
- 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 .
Key exclusion criteria (17 listed)
- 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.
- History of lumbar dischernaiation, accompanied by lower limb nerve symptoms that may affect the assessment of the study.
- Participants who are unable or unwilling to undergo MRI examination, or who have contraindications to MRI.
- Participants who are unable or unwilling to undergo joint fluid extraction.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBM-A101Single-dose intra-articular （IA）injection （2ml）(phase Ia) Low dose group， Middle dose group； High dose group； Control group ：Placebo | Drug | Arm of BBM-A101 |
| PlaceboPlacebo(phase Ia) | Drug | Arm of Placebo |
| BBM-A101Single-dose intra-articular （IA）injection （2ml）(phase Ib) Low dose group， High dose group Control group ：Placebo | Drug | Arm of BBM-A101 |
| PlaceboPlacebo（phase Ib） | Drug | Arm of Placebo |
Primary outcome
Incidence of dose limiting toxicity (DLT) events
Time frame: within 4 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: within 52 weeks
To evaluate the safety of BBM-A101 by AEs and SAEs.
5 secondary outcomes
The protein levels of gene expression products in blood and joint fluid
Time frame: within5 years
The shedding of recombinant adeno-associated virus (rAAV) vectors in peripheral blood, joint fluid, urine, feces, saliva, and semen
Time frame: within 5 years
The change in the joint space width as detected by X-ray of the knee joint compared to the baseline
Time frame: within 5 years
The changes in the titers of AAV capsid-binding antibodies in the blood and joint fluid compared to the baseline level
Time frame: within 5 years
The changes in the titers of antibodies binding to the expressed products in the blood and joint fluid compared to the baseline level
Time frame: within 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruitingPhase 2
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.
Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Zhao principal investigator
The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBM-A101 in people with Knee Osteoarthritis, run by Belief BioMed (Beijing) Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenshu Luo, Ph.D (021-33588288, luowenshu@beliefbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) events (time frame: within 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.