Non-hodgkin Lymphoma,B Cell
Conditions
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.
Interventions
DRUGBRL-301
The administered dose is 5×10\^6/kg
Sponsors
Shanghai Tongji Hospital (Tongji Hospital of Tongji University)
Bioray Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | Within 28 Days After BRL-301 Infusion | The number and severity of dose-limiting toxicity (DLT) events |
Countries
China
Contacts
Primary ContactPing Li, phD
Outcome results
None listed