Multiple MyelomaNCT07248176
Universal CAR-T Cell Therapy for MM
A study testing Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Bioray Laboratories at 1 site in China.
Trial summary
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
- What is being tested?
- Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 18 Apr 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expected survival of at least 3 months;
- Subjects should have measurable disease that meets the IMWG 2016 criteria;
- Previously received at least two lines of prior anti-myeloma therapy ；
- Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ；
- BCMA positive；
- ECOG score 0-1；
- No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.
Who cannot join
- Pregnant or breastfeeding women;
- History of other malignant tumors;
- Active autoimmune diseases requiring immunotherapy;
- Previously received allogeneic stem cell transplantation;
- Previous use of CAR-T cells or other genetically modified T cell therapies;
- Previously received targeted BCMA therapy;
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- Severe cardiovascular disease;
- Active infection;
- Positive virology test;
- Clinically significant central nervous system (CNS) diseases or pathological changes.
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, 1 recruiting
- Recruiting
Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
Shanghai, 620000
Ping Li, phD, 13564181131
About this study
Official title: A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.
Read the detailed description
This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for r/r multiple myeloma using universal CAR-T cells targeting BCMA .
- Being tested
- Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell InjectionDrug
Also called BRL-305
The study drug is administered intravenously at a fixed dose within 1-2 days after lymphocyte depletion, and its efficacy and safety are observed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 5.0-10×10^6cells/kg Receives: Drug: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection |
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: Within 28 Days After BRL-305 Infusion
AEs
The total number, incidence, and severity of AEs
Measured: Up to 24 Months After BRL-305 Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start10 Apr 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion18 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Ping Li, PhD, Study director, 13564181131
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248176
- Sponsor's protocol ID
- 2025-BRL-305-01-IIT
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 1 Dec 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07248176
- Acronym / sponsor ID
- 2025-BRL-305-01-IIT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 18 Apr 2028 (estimated)
- First posted
- 25 Nov 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.
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.
Detailed description
This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for r/r multiple myeloma using universal CAR-T cells targeting BCMA .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection5.0-10×10^6cells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Expected survival of at least 3 months;
- Subjects should have measurable disease that meets the IMWG 2016 criteria;
- Previously received at least two lines of prior anti-myeloma therapy ；
- Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ；
- BCMA positive；
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women;
- History of other malignant tumors;
- Active autoimmune diseases requiring immunotherapy;
- Previously received allogeneic stem cell transplantation;
- Previous use of CAR-T cells or other genetically modified T cell therapies;
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 |
|---|---|---|
| Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell InjectionAlso: BRL-305The study drug is administered intravenously at a fixed dose within 1-2 days after lymphocyte depletion, and its efficacy and safety are observed. | Drug | Treatment group |
Primary outcome
DLT
Time frame: Within 28 Days After BRL-305 Infusion
The number and severity of dose-limiting toxicity (DLT) events
AEs
Time frame: Up to 24 Months After BRL-305 Infusion
The total number, incidence, and severity of AEs
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 1 Dec 2025.
- 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.
Ping Li, PhD study director
13564181131
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection in people with Multiple Myeloma and Multiple Myeloma in Relapse, 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 7 inclusion and 10 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 1 Dec 2025. 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?
Contact Ping Li, phD (13564181131, lilyforever76@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Within 28 Days After BRL-305 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 1 Dec 2025.