Actively Recruiting
The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
Led by Bioray Laboratories · Updated on 2025-11-25
18
Participants Needed
3
Research Sites
194 weeks
Total Duration
On this page
Sponsors
B
Bioray Laboratories
Lead Sponsor
C
Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.
CONDITIONS
Official Title
The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign informed consent
- Age 18 years or older
- Estimated survival time of 3 months or more
- At least one measurable lesion per Lugano Classification 2014
- Histopathologically confirmed aggressive B-NHL with CD19 positive tumors
- Relapsed or refractory disease status
- Must have received adequate prior therapy
- No central nervous system lymphoma invasion by MRI
- Hematological and blood biochemistry parameters meeting requirements
- Left ventricular ejection fraction (LVEF) 55% or higher
- No severe pulmonary disorders
- Toxic reactions from prior therapies stable and resolved to grade 1 or less
- ECOG performance status score of 0 or 1
- Physical condition suitable for peripheral blood apheresis
- Willing to follow study protocol rules
You will not qualify if you...
- Pregnant or breastfeeding women
- Prior allogeneic cell therapies including stem cell transplant
- Prior anti-CD19 therapy or CAR-T/genetically modified T cell therapies (except BRL-201 reinfusion)
- History of Richter's transformation of CLL
- Uncontrolled infections needing systemic therapy
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with active viral load
- Severe mental disorders or CNS disease history
- Active autoimmune disorders requiring immunotherapy or systemic immunosuppressants within past 2 years
- Primary immunodeficiency
- History of other malignancies
- Severe cardiovascular disorders or recent significant heart disease
- Recent deep vein thrombosis or pulmonary embolism
- Current oral anticoagulant therapy or abnormal coagulation tests without treatment
- Presence of indwelling tubes or catheters except central venous access devices
- CNS lymphoma, brain metastases, or lymphoma cells in cerebrospinal fluid
- Conditions requiring emergency treatment due to tumor masses
- History of severe immediate drug hypersensitivity
- Live vaccine within 6 weeks before pretreatment (except COVID-19 vaccines)
- Any condition increasing risk or interfering with study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Wuhan Union Hospital
Wuhan, Hubei, China
Actively Recruiting
2
Tianjin Institute of Hematology
Tianjin, Tianjin Municipality, China
Actively Recruiting
3
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Wei Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here