Refractory/Relapsed B-cell LymphomaPhase 1NCT07398963
Clinical Study of Oncolytic Vaccinia VIrus Delivering Targeted CD19 in Vivo CAR-T/M Therapy for Refractory/Relapsed B-cell Lymphoma
A Phase 1 study testing CD19-CAR novel oncolytic vaccinia virus in people with Refractory/Relapsed B-cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory/Relapsed B-cell Lymphoma
- What is being tested?
- CD19-CAR novel oncolytic vaccinia virus
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 lymphoma (MCL), transformed follicular cell lymphoma (TFL) and other indolent B-cell NHL transformed types;
- 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 progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation;
- 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;
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- 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);
- 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 fraction (EF) ≥ 50%;
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wenbin Qian， Professor, +8613605801032, qianwb@zju.edu.cn
About this study
Official title: Exploratory Study of Oncolytic Vaccinia VIrus-Delivered Targeted CD19 In Vivo CAR-T/M Therapy for Refractory/Relapsed B-Cell Lymphoma
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
Read the detailed description
This is a single-arm, dose-escalation, non-randomized, multicenter, dose-escalation exploratory study aimed at evaluating the safety and efficacy of a novel CD19-CAR oncolytic vaccinia virus (RGV005) in patients with B-cell lymphoma.
The study included two groups: (1) intratumoral injection group (12-24 patients); (2) intravenous injection group (12-24 patients). A standard 3×3 design will be used to conduct a single-dose escalation safety and tolerability trial. Patients will be assigned to one of four dose groups in ascending order: Dose Group 1 (1×10^8 pfu), Dose Group 2 (3×10^8 pfu), Dose Group 3 (1×10^9 pfu), and Dose Group 4 (3×10^9 pfu). Each dose group plans to recruit 3 subjects. After completing the treatment and the month-3 assessment visit, subjects will enter the long-term follow-up period, which will last for 3 years after administration for each patient.
- Conditions
- Refractory/Relapsed B-cell Lymphoma
- Being tested
- CD19-CAR novel oncolytic vaccinia virus
- Keywords
- Oncolytic poxvirus, In vivo CAR-T
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-CAR novel oncolytic vaccinia virusBiological
Injection of CD19-CAR novel oncolytic vaccinia virus which carrying the CD19-CAR gene (RGV005) is designed to locally induce the in situ generation of CAR-T and CAR-M cells in tumors for precise lymphoma killing.
| Study group | Role | What they receive |
|---|---|---|
| intratumoral or intravenous injection RGV005 | Experimental | Subjects will receive intratumoral injections of CD19-CAR oncolytic vaccinia virus (RGV005) Receives: Biological: CD19-CAR novel oncolytic vaccinia virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLTs)
To evaluate the safety, and tolerability, and determine the recommended dosage of the CD19-CAR novel oncolytic vaccinia virus
Measured: Up to 28 days
Secondary outcomes (6)
Complete response rate (CR)
To determine the anti-tumor effectivity of To determine the anti-tumor effectivity of the CD19-CAR novel oncolytic vaccinia virus
Measured: Up to 2 years
Progression free survival (PFS)
Measured: Up to 2 years
Duration of response (DOR)
Measured: Up to 2 years
Overall survival (OS)
Measured: Up to 2 years
Partial response rate (PR)
Measured: Up to 2 years
Overall response rate (ORR)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory/Relapsed B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398963
- Sponsor's protocol ID
- 2026-0013
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Oncolytic Vaccinia VIrus-Delivered Targeted CD19 In Vivo CAR-T/M Therapy for Refractory/Relapsed B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07398963
- Acronym / sponsor ID
- 2026-0013
- Conditions
- Refractory/Relapsed B-cell Lymphoma
- Keywords
- Oncolytic poxvirus, In vivo CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a single-arm, dose-escalation, non-randomized, multicenter, dose-escalation exploratory study aimed at evaluating the safety and efficacy of a novel CD19-CAR oncolytic vaccinia virus (RGV005) in patients with B-cell lymphoma.
The study included two groups: (1) intratumoral injection group (12-24 patients); (2) intravenous injection group (12-24 patients). A standard 3×3 design will be used to conduct a single-dose escalation safety and tolerability trial. Patients will be assigned to one of four dose groups in ascending order: Dose Group 1 (1×10^8 pfu), Dose Group 2 (3×10^8 pfu), Dose Group 3 (1×10^9 pfu), and Dose Group 4 (3×10^9 pfu). Each dose group plans to recruit 3 subjects. After completing the treatment and the month-3 assessment visit, subjects will enter the long-term follow-up period, which will last for 3 years after administration for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intratumoral or intravenous injection RGV005 | Experimental | Biological: CD19-CAR novel oncolytic vaccinia virusSubjects will receive intratumoral injections of CD19-CAR oncolytic vaccinia virus (RGV005) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 lymphoma (MCL), transformed follicular cell lymphoma (TFL) and other indolent B-cell NHL transformed types;
- 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 progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19-CAR novel oncolytic vaccinia virusInjection of CD19-CAR novel oncolytic vaccinia virus which carrying the CD19-CAR gene (RGV005) is designed to locally induce the in situ generation of CAR-T and CAR-M cells in tumors for precise lymphoma killing. | Biological | intratumoral or intravenous injection RGV005 |
Primary outcome
Incidence of dose limiting toxicity (DLTs)
Time frame: Up to 28 days
To evaluate the safety, and tolerability, and determine the recommended dosage of the CD19-CAR novel oncolytic vaccinia virus
6 secondary outcomes
Complete response rate (CR)
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Partial response rate (PR)
Time frame: Up to 2 years
Overall response rate (ORR)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19-CAR novel oncolytic vaccinia virus in people with Refractory/Relapsed B-cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Qian， Professor (+8613605801032, qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLTs) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.