ClinicalTrials.gg
RecruitingNCT07248163Updated Nov 25, 2025

Universal CAR-T Cell Therapy for NHL

An interventional study of BRL-301 in Non-hodgkin Lymphoma,B Cell, sponsored by Bioray Laboratories. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Bioray Laboratories · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2025, registered Nov 2025).
  • Started Mar 2025; still recruiting 1 year 8 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 283 studies in Lymphoma, B-Cell with a site in China — 125 open to participants now, 146 under way, 9 of them phase 3. Lymphoma, B-Cell · China.

Planned enrollment
255th of 273
6 · median 30
Started
2025
with 40 others
No phase
13 of 283
6 open now
Primary completion
2027-08
later than 88 of 145 live
Registered
252nd of 283
by date

Among the 283 studies in Lymphoma, B-Cell with a site in China, this one is the 255th largest by planned enrollment of the 273 interventional ones that give a count, is one of 41 that started in 2025, is one of 13 with no phase, reaches primary completion later than 88 of the 145 other live ones, and was the 252nd registered.

Lymphoma, B-Cell

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

Browse Lymphoma, B-Cell studies →

Open to participants now

125 of the 283 studies in Lymphoma, B-Cell with a site in China are open now. Recruiting first, the newest first:

120 more — sign in →

All 125 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 209 Lymphoma, B-Cell studies recruiting now, 129 (62%) set no upper age limit and 60 (29%) stop at 75 or younger; 37 take children under 18; 3 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 283 studies in Lymphoma, B-Cell with a site in China, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Non-hodgkin Lymphoma,B Cell

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willing to participate in this clinical study and sign an form;
  2. Age ≥ 18 years old;
  3. Estimated survival time ≥ 3 months;
  4. At least one ;
  5. CD19 positively expressed;
  6. score 0-1;
  7. Hematology, coagulation and biochemistry parameters meeting the requirements;
  8. ≥ 55%;
  9. No severe pulmonary disorders;

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Subjects who previously received allogeneic cell therapies, including stem cell transplant;
  3. Subjects who previously received anti-CD19 targeted therapy;
  4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;
  5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);
  6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy;
  7. Subjects with positive surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; virus (HCV) antibody positive and peripheral blood HCV RNA positive; (HIV) antibody positive; syphilis test positive;
  8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved disorders);
  9. 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 drugs or other drugs for systemic control of diseases;
  10. Primary immunodeficiency;
  11. History of other ;
  12. Patients with severe cardiovascular disorders;
  13. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Treatment group

    5×10\^6/kgBW

    Drug: BRL-301

Interventions

  • The administered dose is 5×10\^6/kg

    Also known as: Allogeneic Chimeric Antigen Receptor T-Cell Injection Targeting the CD19 Gene

06

What researchers measure

Primary outcomes

  1. DLT

    The number and severity of dose-limiting toxicity (DLT) events

    Time frame: Within 28 Days After BRL-301 Infusion

07

Study locations

1 of 1 sites recruiting
  • Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
    Shanghai, 620000, China
    Recruiting
    • Ping Li, phD · Contact13564181131
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Aug 2027, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 25, 2025
StartActual
Mar 11, 2025
Primary completionEst.
Aug 15, 2027
CompletionEst.
Mar 11, 2028
Last update
Nov 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07248163
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible party
Sponsor
First posted
Nov 25, 2025
Start date
Mar 11, 2025
Primary completion
Aug 15, 2027 (estimated)
Completion
Mar 11, 2028 (estimated)
Last update
Nov 25, 2025

Study contacts

Ping Li, phD
Contact
13564181131

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Studies of the drug tested here: BRL-301

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