Non-hodgkin Lymphoma,B CellNCT07248163
Universal CAR-T Cell Therapy for NHL
A study testing BRL-301 in people with Non-hodgkin Lymphoma,B Cell, run by Bioray Laboratories at 1 site in China.
Trial summary
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkin Lymphoma,B Cell
- What is being tested?
- BRL-301
- 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
- 11 Mar 2025to 11 Mar 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
- Willing to participate in this clinical study and sign an informed consent form;
- Age ≥ 18 years old;
- Estimated survival time ≥ 3 months;
- At least one measurable lesion;
- CD19 positively expressed;
- ECOG score 0-1；
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- Hematology, coagulation and biochemistry parameters meeting the requirements;
- LVEF ≥ 55%;
- No severe pulmonary disorders;
Who cannot join
- Pregnant or lactating women;
- Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
- Subjects who previously received anti-CD19 targeted therapy;
- Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;
- History of Richter's transformation of chronic lymphocytic leukemia (CLL);
- Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy;
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- Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
- Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);
- Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;
- Primary immunodeficiency;
- History of other malignancies;
- Patients with severe cardiovascular disorders;
- Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ping Li, phD contact
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 of the Safety and Efficacy of Universal CAR-T Cells Targeting CD19 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.
Read the detailed description
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects. Evaluating the safety, tolerability, and efficacy of BRL-301 at a dose level of 5E6/kg.
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Being tested
- BRL-301
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRL-301Drug
Also called Allogeneic Chimeric Antigen Receptor T-Cell Injection Targeting the CD19 Gene
The administered dose is 5×10^6/kg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 5×10^6/kgBW Receives: Drug: BRL-301 |
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-301 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 start11 Mar 2025
- Primary completion15 Aug 2027 (estimated)
- Study completion11 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin Lymphoma,B CellStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248163
- Sponsor's protocol ID
- 2025-BRL-301-02-IIT
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting CD19 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07248163
- Acronym / sponsor ID
- 2025-BRL-301-02-IIT
- Conditions
- Non-hodgkin Lymphoma,B Cell
- 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
- 11 Mar 2025 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 11 Mar 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 is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.
Detailed description
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects. Evaluating the safety, tolerability, and efficacy of BRL-301 at a dose level of 5E6/kg.
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: BRL-3015×10^6/kgBW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing to participate in this clinical study and sign an informed consent form;
- Age ≥ 18 years old;
- Estimated survival time ≥ 3 months;
- At least one measurable lesion;
- CD19 positively expressed;
Key exclusion criteria (13 listed)
- Pregnant or lactating women;
- Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
- Subjects who previously received anti-CD19 targeted therapy;
- Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;
- History of Richter's transformation of chronic lymphocytic leukemia (CLL);
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 Chimeric Antigen Receptor T-Cell Injection Targeting the CD19 GeneThe administered dose is 5×10^6/kg | Drug | Treatment group |
Primary outcome
DLT
Time frame: Within 28 Days After BRL-301 Infusion
The number and severity of dose-limiting toxicity (DLT) events
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 25 Nov 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 contact
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 Non-hodgkin Lymphoma,B Cell, 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 9 inclusion and 13 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 25 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 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), 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-301 Infusion). 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 25 Nov 2025.