BridgeMD
New treatment option for Non-hodgkin Lymphoma
Official title GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
ClinicalTrials.gov ID: NCT06875063
What this study is testing
What is GB5005 CART?
GB5005 CART is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
Also referred to as GB5005 chimeric antigen receptor T-cell injection.
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
- To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
- 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 to 70
You may be able to join if
- The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;
- Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;
- Non Hodgkin lymphoma confirmed by cytology and genetics;
- Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;
- When screening, it meets the definition of recurrence or refractory: having received at least second-line or above systemic anti-tumor therapy...
You likely can't join if
- Patients with a history of allergies to serum albumin and DMSO in the past;
- Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV)...
- Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus...
- History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;
- Primary central nervous system tumors or hematological tumors with central nervous system metastases;
- Uncontrolled mental illness;
See the full eligibility criteria
- The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;
- Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;
- Non Hodgkin lymphoma confirmed by cytology and genetics;
- Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;
- When screening, it meets the definition of recurrence or refractory: having received at least second-line or above systemic anti-tumor therapy (including autologous hematopoietic stem cell transplantation) containing...
- There is no obvious evidence of central nervous system lymphoma on brain MRI;
- Blood routine: Neutrophils ≥ 1.0 × 10 \^ 9/L; Hemoglobin ≥ 70 g/L; Platelets ≥ 50 × 10 \^ 9/L;
- Coagulation function: fibrinogen ≥ 1.0 g/L; Activated partial thromboplastin time (APTT) ≤ ULN+10 s, prothrombin time (PT) ≤ ULN+3 s;
- Liver and kidney function indicators: total bilirubin ≤ 1.5 times the upper limit of normal range (excluding Gilbert syndrome or hemolysis), ALT and AST ≤ 3.0 times the upper limit of normal range (ULN), serum...
- Assessment of left ventricular ejection fraction (LVEF) ≥ 45% using echocardiography (ECHO) or radionuclide active vascular scanning (MUGA). (After corrective treatment and meeting the criteria, it can be included in...
- Pulmonary function: Dyspnea ≤ CTCAE level 1 and SaO2 ≥ 92% in indoor air environment; 12. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points;
- Expected survival is greater than 6 months; 14. The people have sufficient levels of functional organs during screening;
- Female participants of childbearing age must undergo a serum pregnancy test during screening and before receiving pre-treatment chemotherapy, and the result must be negative. They are willing to use highly effective and...
- Male participants who engage in active sexual activity with women with reproductive potential must be willing to use highly effective and reliable methods of contraception within one year after using the study...
- Patients with a history of allergies to serum albumin and DMSO in the past;
- Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV) infection;
- Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, or the need for systemic use of immunosuppressive or other...
- History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;
- Primary central nervous system tumors or hematological tumors with central nervous system metastases;
- Uncontrolled mental illness;
- Merge other life-threatening severe organ failure;
- Participated in other clinical studies within 4 weeks;
- Received live vaccination within 4 weeks of enrollment;
- Using prohibited drugs: a. Hormones: Corticosteroids (defined as\>20mg/day prednisone or equivalent) used at therapeutic doses within 7 days prior to leukocyte collection. But the use of physiological substitutes, local...
- Patients with known history of lung injury or hemorrhagic cystitis associated with cyclophosphamide treatment;
- Women who are already pregnant, preparing for pregnancy during the trial period, or breastfeeding; 13：As per the investigator's judgment, the subject is unlikely to complete all required visits or procedures stipulated...
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, 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.