Autoimmune DiseasePhase 1NCT06633042
The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD
A Phase 1 study testing Universal BCMA-CD19 CART in people with Autoimmune Disease, run by Bioray Laboratories.
Trial summary
This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Disease
- What is being tested?
- Universal BCMA-CD19 CART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2024to 12 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Aged 18-65 years ; both genders eligible.
- Meets the criteria for Refractory NMOSD.
- Anticipated survival of ≥ 12 weeks as judged by the researcher.
- Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
- Provides written informed consent.
Who cannot join
- History of solid organ transplantation.
- Malignant tumor within the last two years.
- Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
- Primary immunodeficiency (congenital or acquired).
- Severe cardiac disease.
- History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
- Allergic constitution or a history of severe allergies.
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disease
This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.
Read the detailed description
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).
- Conditions
- Autoimmune Disease
- Being tested
- Universal BCMA-CD19 CART
- Keywords
- Universal BCMA CART, AQP4 Antibody Positive, RefractoryNeuromyelitis Optica Spectrum Disease
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal BCMA-CD19 CARTDrug
Also called BRL-302
1.0-4.0×10^6 CAR-T cells/kg
| Study group | Role | What they receive |
|---|---|---|
| BCMA CART Group | Experimental | 1.0-4.0×10^6 CAR- Tcells/kg Receives: Drug: Universal BCMA-CD19 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
The number and severity of dose-limiting toxicity (DLT) events
Measured: Within28 Days After BRL-302 Infusion
AEs
The total number, incidence, and severity of AEs
Measured: Up to 12 Months After BRL-302 Infusion
Secondary outcomes (1)
Annualized relapse rate (ARR)
Number of NMOSD relapses in subjects after cell infusion divided by observation time (years)
Measured: 1,3,6,12 month after BRL-302 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start25 Nov 2024 (estimated)
- Primary completion12 Oct 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseaseStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Total target count of CD3+CAR+ viable cells of 1E6/kg 、2E6/kg and 4E6/kg
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wenzhou Medical University Affiliated Ophthalmology Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaohui Wang, PhD, Study chair, Wenzhou Medical University Affiliated Ophthalmology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633042
- Sponsor's protocol ID
- 2024-BRL-302-01
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disease
- ClinicalTrials.gov ID
- NCT06633042
- Acronym / sponsor ID
- 2024-BRL-302-01
- Conditions
- Autoimmune Disease
- Keywords
- Universal BCMA CART, AQP4 Antibody Positive, RefractoryNeuromyelitis Optica Spectrum Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Wenzhou Medical University Affiliated Ophthalmology Hospital
- Study start
- 25 Nov 2024 (estimated)
- Primary completion
- 12 Oct 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 9 Oct 2024 (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 open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.
Detailed description
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Total target count of CD3+CAR+ viable cells of 1E6/kg 、2E6/kg and 4E6/kg
| Arm | Type | Receives |
|---|---|---|
| BCMA CART Group | Experimental | Drug: Universal BCMA-CD19 CART1.0-4.0×10^6 CAR- Tcells/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years ; both genders eligible.
- Meets the criteria for Refractory NMOSD.
- Anticipated survival of ≥ 12 weeks as judged by the researcher.
- Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
- Provides written informed consent.
Key exclusion criteria (8 listed)
- History of solid organ transplantation.
- Malignant tumor within the last two years.
- Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
- Primary immunodeficiency (congenital or acquired).
- Severe cardiac 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 |
|---|---|---|
| Universal BCMA-CD19 CARTAlso: BRL-3021.0-4.0×10^6 CAR-T cells/kg | Drug | BCMA CART Group |
Primary outcome
DLT
Time frame: Within28 Days After BRL-302 Infusion
The number and severity of dose-limiting toxicity (DLT) events
AEs
Time frame: Up to 12 Months After BRL-302 Infusion
The total number, incidence, and severity of AEs
1 secondary outcome
Annualized relapse rate (ARR)
Time frame: 1,3,6,12 month after BRL-302 infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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. This study is not recruiting at the moment.
Xiaohui Wang, PhD study chair
Wenzhou Medical University Affiliated Ophthalmology Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Universal BCMA-CD19 CART in people with Autoimmune Disease, run by Bioray Laboratories.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Wang, PhD (18701533866, xiaoxiao512006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Within28 Days After BRL-302 Infusion). 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 12 Nov 2024.