Universal CAR-T Cell Therapy for NHL

NCT07248163 | Recruiting

• 1 other identifier: 2025-BRL-301-02-IIT
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.

Conditions

Non-hodgkin Lymphoma,B Cell

Outcome Measures

Primary Outcomes (1)

• DLT

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

  Within 28 Days After BRL-301 Infusion

Study Arms (1)

Treatment group

EXPERIMENTAL

5×10\^6/kgBW

Drug: BRL-301

Interventions

BRL-301 DRUG

The administered dose is 5×10\^6/kg

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

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioray Laboratories: lead
• Shanghai Tongji Hospital (Tongji Hospital of Tongji University): collaborator

Study Sites (1)

Shanghi Tongji Hospital (Tongji Hospital of Tongji University)

Shanghai, 620000, China

RECRUITING

Central Study Contacts

Ping Li, phD

CONTACT

13564181131

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): March 11, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)