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Tests treatment safety and results for Non-hodgkin Lymphoma,B Cell
Official title The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05741359
What this study is testing
What is CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection?
CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for non-hodgkin lymphoma,b cell.
Also referred to as BRL-201.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing to participate in this clinical study and sign an informed consent form;
- Age ≥ 18 years old;
- Estimated survival time ≥ 3 months;
- Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the...
- Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in tumors detected by immunohistochemistry or flow cytometry...
You likely can't join if
- Pregnant or lactating women;
- people who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
- people who previously received anti-CD19 targeted therapy, except those who receive BRL-201 and are eligible to receive reinfusion in this study;
- 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. Patients can be enrolled if the simple urinary...
See the full eligibility criteria
- Willing to participate in this clinical study and sign an informed consent form;
- Age ≥ 18 years old;
- Estimated survival time ≥ 3 months;
- 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...
- 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);
- Relapsed or refractory diseases;
- people who must receive adequate prior therapy;
- Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic resonance imaging (MRI);
- Hematological parameters meeting the requirements;
- Blood biochemistry meeting the requirements;
- LVEF ≥ 55%;
- No severe pulmonary disorders;
- Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved to grade ≤ 1;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to abide by the rules formulated in the study protocol.
- Pregnant or lactating women;
- people who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
- people who previously received anti-CD19 targeted therapy, except those who receive BRL-201 and are eligible to receive reinfusion in this study;
- 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. Patients can be enrolled if the simple urinary tract infection or pharyngitis responds to treatment;
- people 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...
- 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...
- Primary immunodeficiency;
- History of other malignancies;
- 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...
- History of deep venous thrombosis or pulmonary embolism within 6 months before enrollment;
- 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;
- 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...
- 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;
- Conditions (e.g., intestinal obstruction or vascular compression) requiring emergency treatment due to tumor masses;
- History of severe immediate hypersensitivity to any drug to be used in this study;
- Vaccination of live vaccines, excluding corona virus disease 2019 (COVID-19) vaccines, within ≤ 6 weeks before the start of the pretreatment regimen;
- Any circumstances that possibly increase the risk of people or interfere with the study results as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.