The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma

NCT05741359 | Recruiting Phase 1

• 1 other identifier: 2022-BRL-201
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.

Conditions

Non-hodgkin Lymphoma,B Cell

Outcome Measures

Primary Outcomes (3)

• DLT

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

  Within 28 Days After BRL-201 Infusion

• AEs

  The total number, incidence, and severity of AEs

  Up to 24 Months After BRL-201 Infusion

• RP2D

  The recommended phase 2 dose

  Within 28 Days After BRL-201 Infusion

Study Arms (1)

Treatment group

EXPERIMENTAL

5- 10.0×10\^6/kgBW

Drug: CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection

Interventions

CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection DRUG

CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection

Also known as: BRL-201

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;
• Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional images obtained by CT show that the long diameter of lymph node lesions is \> 15 mm or the long diameter of extranodal lesions is \> 10 mm, and FDG-PET scan results are positive). Lesions, for which radiotherapy was provided, can be regarded as measurable lesions only if there is an unequivocal progression after radiotherapy;
• Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in tumors detected by immunohistochemistry or flow cytometry; pathological types of B-NHL (according to WHO Lymphoma Classification 2016);
• Relapsed or refractory diseases;
• Subjects who must receive adequate prior therapy;
• Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic resonance imaging (MRI);
• Hematological parameters meeting the requirements;
• Blood biochemistry meeting the requirements;
• LVEF ≥ 55%;
• No severe pulmonary disorders;
• Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved to grade ≤ 1;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to abide by the rules formulated in the study protocol.

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, except those who receive BRL-201 and are eligible to receive reinfusion in this study;
• 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. Patients can be enrolled if the simple urinary tract infection or pharyngitis responds to treatment;
• 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, including but not limited to those with lymphoma infiltration in the cardiac atrium or ventricles and those with a history of myocardial infarction, cardioangioplasty or stent implantation, unstable angina, or other clinically significant heart diseases within 12 months before enrollment;
• History of deep venous thrombosis or pulmonary embolism within 6 months before enrollment;
• Patients who are receiving oral anticoagulant therapy; prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) \> 1.5 × ULN without anticoagulant therapy;
• Presence of any indwelling tube or catheter (e.g., tube or catheter for percutaneous nephrostomy, indwelling catheter, or catheter in pleural cavity/peritoneal cavity/pericardium). Dedicated central venous access catheters (e.g., Port-a-Cath or Hickman catheter) are permitted;

Sponsors & Collaborators

• Bioray Laboratories: lead
• Chinese Academy of Medical Sciences: collaborator
• Zhejiang University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (3)

Wuhan Union Hospital

Wuhan, Hubei, China

RECRUITING

Tianjin Institute of Hematology

Tianjin, Tianjin Municipality, China

RECRUITING

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Study Officials

• Wei Li

  Bioray Laboratories

  STUDY CHAIR

Central Study Contacts

Wei Li, PhD

CONTACT

18621670308; wli@brlmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Total target count of CD3+CAR+ viable cells

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: April 25, 2023
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)