Universal CAR-T Cell Therapy for NHL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BRL-301.
- Who it may be relevant to
- Registry conditions: Non-hodgkin Lymphoma,B Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting CD19 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
Overview
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.
Interventions
- Drug BRL-301
The administered dose is 5×10\^6/kg
Primary outcome measures
- DLT [Time frame: Within 28 Days After BRL-301 Infusion]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghi Tongji Hospital (Tongji Hospital of Tongji University) — Shanghai
Identifiers
NCT: NCT07248163 · 2025-BRL-301-02-IIT