Oncolytic vaccinia virus delivering CD19 to create CAR‑T therapy inside the body for relapsed/refractory B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, single‑arm, multicenter dose‑escalation study testing a CD19‑CAR‑encoding oncolytic vaccinia virus (RGV005) in patients with relapsed or refractory B‑cell non‑Hodgkin lymphoma. Participants are assigned to intratumoral or intravenous administration arms and enrolled into a standard 3×3 single‑dose escalation across four dose levels (1×10^8 to 3×10^9 pfu). Each planned dose cohort enrolls three subjects and safety, tolerability, and preliminary anti‑tumor activity are followed, with a primary safety focus. After treatment and a month‑3 assessment, patients enter a long‑term follow‑up of up to three years.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Wenbin Qian， Professor
• Email: qianwb@zju.edu.cn
• Phone: +8613605801032

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

  This trial tries loncastuximab tesirine with rituximab as a bridge before commercial CD19 CAR‑T therapy for adults with relapsed or refractory large B‑cell lymphoma to see if it is safe and helps control disease before CAR‑T.

  Recruiting at 2 sites Phase 2 University of Utah · Chapel Hill, North Carolina and 1 other locations · NCT06788964

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.