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

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.

02

Conditions studied

  • Non-hodgkin Lymphoma,B Cell
03

In context

Lead sponsor

Bioray Laboratories is the lead sponsor of 24 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Subjects who previously received allogeneic cell therapies, including allogeneic 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 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;
  8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune 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 immunosuppressive drugs or other drugs for systemic control of diseases;
  10. Primary immunodeficiency;
  11. History of other malignancies;
  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.
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

  • DrugBRL-301

    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
    • Ping Li, phD · Contact · 13564181131
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
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
Lead sponsor
Bioray Laboratories
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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