Systemic Lupus Erythematosus (SLE)NCT05859997
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
A study testing BRL-301 in people with Systemic Lupus Erythematosus (SLE) and Sjogren's Syndrome, run by Bioray Laboratories at 1 site in China.
Trial summary
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis
- What is being tested?
- BRL-301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2023to 27 May 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals with a history of severe drug allergies or allergic constitution.
- Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections.
- Individuals with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia.
- Subjects with congenital immunoglobulin deficiency.
- Other malignant tumors (excluding non-melanoma skin cancer, cervical cancer in situ, bladder cancer and breast cancer that have survived for more than 5 years without disease).
- Subjects with end-stage renal failure.
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- Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis.
- Having mental illness and severe cognitive impairment.
- Those who have participated in other clinical trials within the first 3 months of enrollment.
- Pregnant or intending to conceive women.
- The researchers believe that there are other reasons why subjects cannot be included in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai ChangZheng hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (BRL-301) in the Treatment of Relapse or Refractory Autoimmune Diseases
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
Read the detailed description
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
The study had the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, ANCA Associated Systemic Vasculitis, Antiphospholipid Syndrome
- Being tested
- BRL-301
- Medical subject headings
- Lupus Erythematosus, Systemic, Sjogren's Syndrome, Scleroderma, Systemic, Myositis, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRL-301Biological
Also called Allogeneic Anti-CD19 CAR T cells
Single dose of Allogeneic Anti-CD19 CAR T cells will be infused
| Study group | Role | What they receive |
|---|---|---|
| BRL-301 | Experimental | Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Receives: Biological: BRL-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy outcomes
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards；Efficacy assessments: Relapsed refractory systemic lupus erythematosus-SLE Response Index 4 (SRI-4) response;Sjögren's Syndrome with relapsed refractory thrombocytopenia-assessment of treatment response for thrombocytopenia(CR, PR, NR);Relapsed refractory/progressive systemic sclerosis-Composite Response Index in Systemic Sclerosis(CRISS);Relapsed refractory/progressive inflammatory myopathy-Total Improvement Score (TIS);Relapsed refractory ANCA-associated vasculitis-BVAS score;Recurrent Refractory/Catastrophic Antiphospholipid Syndrome-new thrombosis
Measured: First 30 days for DLT, 3 months for safety and efficacy measurements during the treatment assessment period, and then follow-up every 3 months for up to a year after the treatment.
Secondary outcomes (2)
PK parameters
Changes in the CAR gene copy number and CAR-T cell count in peripheral blood and duration after infusion of BRL-301; time to peak (Tmax), peak concentration (Cmax), area under the concentration-time curve from 0 to 1 month (AUC0-M1), and from 0 to 3 months (AUC0-M3)
Measured: 3 months
PD parameters
Changes in cytokines in peripheral blood after infusion of BRL-301
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start17 May 2023
- Primary completion27 May 2024
- Study completion27 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859997
- Sponsor's protocol ID
- 2022-BRL-301A-ADS-IIT
- Status last verified
- Nov 2024
- First submitted
- 19 Apr 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang D, Wang X, Tan B, Wen X, Ye S, Wu Y, Cao X, Zhang X, Wang C, Geng L, Zhang H, Feng X, Zheng B, He Y, Liu M, Wu X, Du B, Sun L, Xu H. Allogeneic CD19-targeted CAR-T therapy in refractory systemic lupus erythematosus achieved durable remission. Med. 2025 Oct 10;6(10):100749. doi: 10.1016/j.medj.2025.100749. Epub 2025 May 29.
PubMed 40446794Wang X, Wu X, Tan B, Zhu L, Zhang Y, Lin L, Xiao Y, Sun A, Wan X, Liu S, Liu Y, Ta N, Zhang H, Song J, Li T, Zhou L, Yin J, Ye L, Lu H, Hong J, Cheng H, Wang P, Li W, Chen J, Zhang J, Luo J, Huang M, Guo L, Pan X, Jin Y, Ye W, Dai L, Zhu J, Sun L, Zheng B, Li D, He Y, Liu M, Wu H, Du B, Xu H. Allogeneic CD19-targeted CAR-T therapy in patients with severe myositis and systemic sclerosis. Cell. 2024 Sep 5;187(18):4890-4904.e9. doi: 10.1016/j.cell.2024.06.027. Epub 2024 Jul 15.
PubMed 39013470
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (BRL-301) in the Treatment of Relapse or Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT05859997
- Acronym / sponsor ID
- 2022-BRL-301A-ADS-IIT
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, ANCA Associated Systemic Vasculitis, Antiphospholipid Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital
- Study start
- 17 May 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2025 (estimated)
- First posted
- 16 May 2023 (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.
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
Detailed description
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
The study had the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRL-301 | Experimental | Biological: BRL-301Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Individuals with a history of severe drug allergies or allergic constitution.
- Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections.
- Individuals with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia.
- Subjects with congenital immunoglobulin deficiency.
- Other malignant tumors (excluding non-melanoma skin cancer, cervical cancer in situ, bladder cancer and breast cancer that have survived for more than 5 years without disease).
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 |
|---|---|---|
| BRL-301Also: Allogeneic Anti-CD19 CAR T cellsSingle dose of Allogeneic Anti-CD19 CAR T cells will be infused | Biological | BRL-301 |
Primary outcome
Safety and efficacy outcomes
Time frame: First 30 days for DLT, 3 months for safety and efficacy measurements during the treatment assessment period, and then follow-up every 3 months for up to a year after the treatment.
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards；Efficacy assessments: Relapsed refractory systemic lupus erythematosus-SLE Response Index 4 (SRI-4) response;Sjögren's Syndrome with relapsed refractory thrombocytopenia-assessment of treatment response for thrombocytopenia(CR, PR, NR);Relapsed refractory/progressive systemic sclerosis-Composite Response Index in Systemic Sclerosis(CRISS);Relapsed refractory/progressive inflammatory myopathy-Total Improvement Score (TIS);Relapsed refractory ANCA-associated vasculitis-BVAS score;Recurrent Refractory/Catastrophic Antiphospholipid Syndrome-new thrombosis
2 secondary outcomes
PK parameters
Time frame: 3 months
PD parameters
Time frame: 3 months
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 20 Nov 2024.
- Derived from this study: PubMed 40446794Wang D, Wang X, Tan B, Wen X, Ye S, Wu Y, Cao X, Zhang X, Wang C, Geng L, Zhang H, Feng X, Zheng B, He Y, Liu M, Wu X, Du B, Sun L, Xu H. Allogeneic CD19-targeted CAR-T therapy in refractory systemic lupus erythematosus achieved durable remission. Med. 2025 Oct 10;6(10):100749. doi: 10.1016/j.medj.2025.100749. Epub 2025 May 29.
- Derived from this study: PubMed 39013470Wang X, Wu X, Tan B, Zhu L, Zhang Y, Lin L, Xiao Y, Sun A, Wan X, Liu S, Liu Y, Ta N, Zhang H, Song J, Li T, Zhou L, Yin J, Ye L, Lu H, Hong J, Cheng H, Wang P, Li W, Chen J, Zhang J, Luo J, Huang M, Guo L, Pan X, Jin Y, Ye W, Dai L, Zhu J, Sun L, Zheng B, Li D, He Y, Liu M, Wu H, Du B, Xu H. Allogeneic CD19-targeted CAR-T therapy in patients with severe myositis and systemic sclerosis. Cell. 2024 Sep 5;187(18):4890-4904.e9. doi: 10.1016/j.cell.2024.06.027. Epub 2024 Jul 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRL-301 in people with Systemic Lupus Erythematosus (SLE) and Sjogren's Syndrome, run by Bioray Laboratories at 1 site 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 0 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy outcomes (time frame: First 30 days for DLT, 3 months for safety and efficacy measurements during the treatment assessment period, and then follow-up every 3 months for up to a year after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859997, which also lists 2 linked publications.
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 20 Nov 2024.