Recruiting

BBM-A101 Gene Therapy for Knee Osteoarthritis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

BBM-A101

+ Placebo

Drug
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

From 40 to 75 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorBelief BioMed (Beijing) Co., Ltd
Study ContactWenshu Luo, Ph.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 9, 2025

Actual date on which the first participant was enrolled.

This clinical study is focused on examining a new treatment for individuals with knee osteoarthritis using a gene therapy called BBM-A101. Knee osteoarthritis is a common joint condition that causes pain and stiffness, often affecting daily activities. The treatment involves delivering a therapeutic gene directly into the knee, which aims to potentially improve the symptoms and quality of life for patients suffering from this condition. This research is important as it could offer a new way to manage osteoarthritis, especially for those who may not find relief from current treatments. Participants in this study will receive the treatment through an injection directly into the knee. The study is divided into two parts: the first part is a randomized, single-blind study, while the second part is a randomized, double-blind study. This means that in some parts of the study, neither the participants nor the researchers know who receives the actual treatment or a placebo, ensuring unbiased results. The study will assess the safety and effectiveness of BBM-A101, closely monitoring any side effects and improvements in knee function.

Official TitleA Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis .
NCT07198555
Principal SponsorBelief BioMed (Beijing) Co., Ltd
Study ContactWenshu Luo, Ph.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

81 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

7 inclusion criteria required to participate
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 .
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).
Show More Criteria
16 exclusion criteria prevent from participating
Participants who are unable or unwilling to undergo joint fluid extraction.
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Shenzhen Second People's Hospital

Shenzhen, ChinaOpen Shenzhen Second People's Hospital in Google Maps
Recruiting

The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine

Shanghai, China
Recruiting
2 Study Centers