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New treatment option for Refractory/Relapsed B-cell Lymphoma
Official title Clinical Study of Oncolytic Vaccinia VIrus Delivering Targeted CD19 in Vivo CAR-T/M Therapy for Refractory/Relapsed B-cell Lymphoma
ClinicalTrials.gov ID: NCT07398963
What this study is testing
What is CD19-CAR novel oncolytic vaccinia virus?
CD19-CAR novel oncolytic vaccinia virus is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory/relapsed b-cell lymphoma.
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 study the safety and effectiveness of oncolytic Vaccinia VIrus-Delivered Targeted CD19 In Vivo CAR-T/M Therapy for Refractory/Relapsed B-Cell Lymphoma
- Phase 1: an early, usually small safety study
- Time commitment: about 3 years
- Which group you join is decided by chance.
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 75
You may be able to join if
- Age≥ 18 years old, up to 75 years old, male or female;
- ECOG score 0-2;
- Histologically confirmed non-Hodgkin B-cell lymphoma (NHL) [diagnostic criteria are WHO2008], including diffuse large B-cell lymphoma (DLBCL)...
- CD19 positive (immunohistochemistry or flow cytometry);
- DLBCL refractory or relapse is defined as: complete remission after 2 lines of therapy; Disease progression during any course of treatment, or...
You likely can't join if
- History of other tumors;
- Vaccination with the smallpox vaccine within 3 months before or during the study treatment;
- Receiving gene therapy or any type of oncolytic virus therapy within 3 months before the study treatment;
- Other open wounds;
- Active autoimmune diseases;
- Uncontrolled active infections;
See the full eligibility criteria
- Age≥ 18 years old, up to 75 years old, male or female;
- ECOG score 0-2;
- Histologically confirmed non-Hodgkin B-cell lymphoma (NHL) [diagnostic criteria are WHO2008], including diffuse large B-cell lymphoma (DLBCL) non-specific, primary mediastinal large B-cell lymphoma (PMBCL), mantle cell...
- CD19 positive (immunohistochemistry or flow cytometry);
- DLBCL refractory or relapse is defined as: complete remission after 2 lines of therapy; Disease progression during any course of treatment, or disease stabilization time equal to and less than 6 months; or disease...
- MCL: Complete remission after 2 lines of treatment (including BTK inhibitors); Disease progression during any course of treatment, or disease stabilization time equal to and less than 6 months; or disease progression or...
- At least one measurable superficial lesion, requiring any length diameter of lymph node lesion greater than 1.5cm or any length diameter of extranodal lesion greater than 1.0cm, and uptake of the lesion on PET-CT scan...
- Absolute peripheral blood neutrophil ≥ 1000/mm3, platelet ≥ 50,000/mm3;
- Heart, liver and kidney function: creatinine \<1.5mg/dL; ALT (alanine aminotransferase)/AST (aspartate aminotransferase) less than 2.5 times the upper limit of normal; Total bilirubin \< 1.5 mg/dL; Cardiac ejection...
- Have sufficient understanding ability and voluntarily sign the informed consent form;
- Women of childbearing potential must have a negative serum pregnancy test and agree to practice effective birth control during the treatment phase and for 60 days after the last application of oncolytic virus;
- Male patients must agree to practice effective birth control during the study and for 60 days after the last viral treatment.
- History of other tumors;
- Vaccination with the smallpox vaccine within 3 months before or during the study treatment;
- Receiving gene therapy or any type of oncolytic virus therapy within 3 months before the study treatment;
- Other open wounds;
- Active autoimmune diseases;
- Uncontrolled active infections;
- HIV infection, uncontrolled HBV, HCV, or syphilis infection;
- Known central nervous system lymphoma;
- Clinically significant heart disease;
- Allergy to albumin or egg products;
- History of organ transplantation or similar surgeries;
- Need for systemic treatment for skin diseases;
- History of severe systemic reactions or side effects after smallpox vaccination;
- Known alcohol or viral dependence;
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- 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 study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.