Universal CAR-T Cell Therapy for NHL

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.

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.