NCT07398963 Clinical Study of Oncolytic Vaccinia VIrus Delivering Targeted CD19 in Vivo CAR-T/M Therapy for Refractory/Relapsed B-cell Lymphoma
| NCT ID | NCT07398963 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Refractory/Relapsed B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-02 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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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 48 participants in total. It began in 2026-02 with a primary completion date of 2029-07.
⚠ 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
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
Eligibility Criteria
Inclusion Criteria: 1. Age≥ 18 years old, up to 75 years old, male or female; 2. ECOG score 0-2; 3. 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 lymphoma (MCL), transformed follicular cell lymphoma (TFL) and other indolent B-cell NHL transformed types; 4. CD19 positive (immunohistochemistry or flow cytometry); 5. 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 progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation; 6. 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 recurrence within 12 months after autologous hematopoietic stem cell transplantation; 7. 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 (SUV greater than hepatic blood pool); 8. Absolute peripheral blood neutrophil ≥ 1000/mm3, platelet ≥ 50,000/mm3; 9. 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 fraction (EF) ≥ 50%; 10. Have sufficient understanding ability and voluntarily sign the informed consent form; 11. 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; 12. Male patients must agree to practice effective birth control during the study and for 60 days after the last viral treatment. Exclusion Criteria: 1. History of other tumors; 2. Vaccination with the smallpox vaccine within 3 months before or during the study treatment; 3. Receiving gene therapy or any type of oncolytic virus therapy within 3 months before the study treatment; 4. Other open wounds; 5. Active autoimmune diseases; 6. Uncontrolled active infections; 7. HIV infection, uncontrolled HBV, HCV, or syphilis infection; 8. Known central nervous system lymphoma; 9. Clinically significant heart disease; 10. Allergy to albumin or egg products; 11. History of organ transplantation or similar surgeries; 12. Need for systemic treatment for skin diseases; 13. History of severe systemic reactions or side effects after smallpox vaccination; 14. Known alcohol or viral dependence; 15. Pregnant or breastfeeding women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07398963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Refractory/Relapsed B-cell Lymphoma. 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 NCT07398963 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 NCT07398963 currently recruiting?
Yes, NCT07398963 is actively recruiting participants. Contact the research team at qianwb@zju.edu.cn for enrollment information.
Where is the NCT07398963 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07398963 clinical trial?
NCT07398963 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 48 participants.