Universal CAR-T Cell Therapy for NHL

NCT ID: NCT07248163

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2028-03-11

Brief Summary

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

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.

Conditions

Non-hodgkin Lymphoma,B Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

5×10\^6/kgBW

Group Type: EXPERIMENTAL

BRL-301

Intervention Type: DRUG

The administered dose is 5×10\^6/kg

Interventions

BRL-301

The administered dose is 5×10\^6/kg

Intervention Type: DRUG

Other Intervention Names

Allogeneic Chimeric Antigen Receptor T-Cell Injection Targeting the CD19 Gene

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital (Tongji Hospital of Tongji University)

UNKNOWN

Sponsor Role: collaborator

Bioray Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghi Tongji Hospital (Tongji Hospital of Tongji University)

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping Li, phD

Role: CONTACT

13564181131

Facility Contacts

Ping Li, phD

Role: primary

13564181131

Other Identifiers

2025-BRL-301-02-IIT

Identifier Type: -

Identifier Source: org_study_id