Non-hodgkin Lymphoma,B CellPhase 1NCT05741359
The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
A Phase 1 study testing CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection in people with Non-hodgkin Lymphoma,B Cell, run by Bioray Laboratories at 3 sites in China.
Trial summary
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 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?
- CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesChina
- Study dates
- 25 Apr 2023to 15 Jan 2027
- Phase
- Phase 1
- 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;
- Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional images obtained by CT show that the long diameter of lymph node lesions is > 15 mm or the long diameter of extranodal lesions is > 10 mm, and FDG-PET scan results are positive). Lesions, for which radiotherapy was provided, can be regarded as measurable lesions only if there is an unequivocal progression after radiotherapy;
- Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in tumors detected by immunohistochemistry or flow cytometry; pathological types of B-NHL (according to WHO Lymphoma Classification 2016);
- Relapsed or refractory diseases;
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- Subjects who must receive adequate prior therapy;
- Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic resonance imaging (MRI);
- Hematological parameters meeting the requirements;
- Blood biochemistry meeting the requirements;
- LVEF ≥ 55%;
- No severe pulmonary disorders;
- Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved to grade ≤ 1;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to abide by the rules formulated in the study protocol.
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, except those who receive BRL-201 and are eligible to receive reinfusion in this study;
- 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. Patients can be enrolled if the simple urinary tract infection or pharyngitis responds to treatment;
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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, including but not limited to those with lymphoma infiltration in the cardiac atrium or ventricles and those with a history of myocardial infarction, cardioangioplasty or stent implantation, unstable angina, or other clinically significant heart diseases within 12 months before enrollment;
- History of deep venous thrombosis or pulmonary embolism within 6 months before enrollment;
- Patients who are receiving oral anticoagulant therapy; prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) > 1.5 × ULN without anticoagulant therapy;
- Presence of any indwelling tube or catheter (e.g., tube or catheter for percutaneous nephrostomy, indwelling catheter, or catheter in pleural cavity/peritoneal cavity/pericardium). Dedicated central venous access catheters (e.g., Port-a-Cath or Hickman catheter) are permitted;
- Lymphoma cells detected in cerebrospinal fluid, presence of brain metastases, history of CNS lymphoma, or history of lymphoma cells detected in cerebrospinal fluid or brain metastases;
- Conditions (e.g., intestinal obstruction or vascular compression) requiring emergency treatment due to tumor masses;
- History of severe immediate hypersensitivity to any drug to be used in this study;
- Vaccination of live vaccines, excluding corona virus disease 2019 (COVID-19) vaccines, within ≤ 6 weeks before the start of the pretreatment regimen;
- Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
He Huang, PhD
- Recruiting
Tianjin Institute of Hematology
Tianjin, Tianjin Municipality
Rugui qiu, PhD
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei
Heng Mei, PhD
About this study
Official title: A Phase I/II Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.
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. Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Being tested
- CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injectionDrug
Also called BRL-201
CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 5- 10.0×10^6/kgBW Receives: Drug: CD19-targeted non-viral PD1 site-specific integrated CAR-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-201 Infusion
AEs
The total number, incidence, and severity of AEs
Measured: Up to 24 Months After BRL-201 Infusion
RP2D
The recommended phase 2 dose
Measured: Within 28 Days After BRL-201 Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start25 Apr 2023
- Primary completion20 Nov 2026 (estimated)
- Study completion15 Jan 2027 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Total target count of CD3+CAR+ viable cells
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Zhejiang University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Wei Li, Study chair, Bioray Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741359
- Sponsor's protocol ID
- 2022-BRL-201
- Status last verified
- Nov 2025
- First submitted
- 14 Feb 2023
- Last updated
- 25 Nov 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05741359
- Acronym / sponsor ID
- 2022-BRL-201
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Zhejiang University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 23 Feb 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 a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.
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. Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Total target count of CD3+CAR+ viable cells
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection5- 10.0×10^6/kgBW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing to participate in this clinical study and sign an informed consent form;
- Age ≥ 18 years old;
- Estimated survival time ≥ 3 months;
- Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional images obtained by CT show that the long diameter of lymph node lesions is > 15 mm or the long diameter of extranodal lesions is > 10 mm, and FDG-PET scan results are positive). Lesions, for which radiotherapy was provided, can be regarded as measurable lesions only if there is an unequivocal progression after radiotherapy;
- Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in tumors detected by immunohistochemistry or flow cytometry; pathological types of B-NHL (according to WHO Lymphoma Classification 2016);
Key exclusion criteria (20 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, except those who receive BRL-201 and are eligible to receive reinfusion in this study;
- 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 |
|---|---|---|
| CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injectionAlso: BRL-201CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection | Drug | Treatment group |
Primary outcome
DLT
Time frame: Within 28 Days After BRL-201 Infusion
The number and severity of dose-limiting toxicity (DLT) events
AEs
Time frame: Up to 24 Months After BRL-201 Infusion
The total number, incidence, and severity of AEs
RP2D
Time frame: Within 28 Days After BRL-201 Infusion
The recommended phase 2 dose
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.
Wei Li study chair
Bioray Laboratories
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection in people with Non-hodgkin Lymphoma,B Cell, run by Bioray Laboratories at 3 sites 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 15 inclusion and 20 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 3 sites 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.
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?
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 Wei Li, PhD (18621670308, wli@brlmed.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-201 Infusion). The study lists 3 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 25 Nov 2025.