Universal CAR-T Cell Therapy for NHL | NCT07248163

Studies
Universal CAR-T Cell Therapy for NHL

NCT07248163

Sponsor

Bioray Laboratories

Status

Recruiting

Last Update Posted

Nov 25, 2025Actual

Enrollment

6Estimated

Phase

Not Applicable

Conditions

Non-hodgkin Lymphoma,B Cell

Interventions

BRL-301

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2025Actual

Primary Completion Date

Aug 15, 2027Estimated

Completion Date

Mar 11, 2028Estimated

First Submitted Date

Nov 18, 2025

First Submission Date that Met QC Criteria

Nov 18, 2025

First Posted Date

Nov 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 25, 2025Actual

Name	Class
Shanghai Tongji Hospital, Tongji University School of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Label	Type	Description	Intervention Names
Treatment group	Experimental	5×10^6/kgBW	Drug: BRL-301

Name	Type	Description	Arm Group Labels	Other Names
BRL-301	Drug	The administered dose is 5×10^6/kg	Treatment group	Allogeneic Chimeric Antigen Receptor T-Cell Injection Targeting the CD19 Gene

Measure	Description	Time Frame
DLT	The number and severity of dose-limiting toxicity (DLT) events	Within 28 Days After BRL-301 Infusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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；
Hematology, coagulation and biochemistry parameters meeting the requirements;
LVEF ≥ 55%;
No severe pulmonary disorders;

Exclusion Criteria:

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;
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided