NCT05741359 The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
| NCT ID | NCT05741359 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bioray Laboratories |
| Condition | Non-hodgkin Lymphoma,B Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-04-25 |
| Primary Completion | 2026-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2023-04-25 with a primary completion date of 2026-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.
Eligibility Criteria
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. 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; 5. 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); 6. Relapsed or refractory diseases; 7. Subjects who must receive adequate prior therapy; 8. Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic resonance imaging (MRI); 9. Hematological parameters meeting the requirements; 10. Blood biochemistry meeting the requirements; 11. LVEF ≥ 55%; 12. No severe pulmonary disorders; 13. Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved to grade ≤ 1; 14. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 15. Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to abide by the rules formulated in the study protocol. 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, except those who receive BRL-201 and are eligible to receive reinfusion in this study; 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. Patients can be enrolled if the simple urinary tract infection or pharyngitis responds to treatment; 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, 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; 13. History of deep venous thrombosis or pulmonary embolism within 6 months before enrollment; 14. 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; 15. 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; 16. Lymphoma cells detected in cerebrospinal fluid, presence of brain metastases, history of CNS lymphoma, or history of lymphoma cells detected in cerebrospinal fluid or brain metastases; 17. Conditions (e.g., intestinal obstruction or vascular compression) requiring emergency treatment due to tumor masses; 18. History of severe immediate hypersensitivity to any drug to be used in this study; 19. Vaccination of live vaccines, excluding corona virus disease 2019 (COVID-19) vaccines, within ≤ 6 weeks before the start of the pretreatment regimen; 20. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.
Contact & Investigator
Wei Li
STUDY CHAIR
Bioray Laboratories
Frequently Asked Questions
Who can join the NCT05741359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-hodgkin Lymphoma,B Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05741359 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05741359 currently recruiting?
Yes, NCT05741359 is actively recruiting participants. Contact the research team at wli@brlmed.com for enrollment information.
Where is the NCT05741359 trial being conducted?
This trial is being conducted at Wuhan, China, Tianjin, China, Hangzhou, China.
Who is sponsoring the NCT05741359 clinical trial?
NCT05741359 is sponsored by Bioray Laboratories. The principal investigator is Wei Li at Bioray Laboratories. The trial plans to enroll 18 participants.