Relapsed or Refractory B-cell LymphomaPhase 1NCT04887025
Exploratory Study of a Novel Oncolytic Vaccinia Virus RGV004 in the Treatment of Refractory/Relapsed B-cell Lymphoma
A Phase 1 study testing RGV004 in people with Relapsed or Refractory B-cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a dose-escalation, single-arm, single-center open study which aims to evaluate the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of a novel oncolytic vaccinia virus expressing bispecific antibody RGV004 in patients with relapsed/refractory B-cell lymphoma, Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory B-cell Lymphoma
- What is being tested?
- RGV004
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2022to 15 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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, the upper limit is 75 years old, there is no restriction on men and women;
- ECOG score 0-1;
- Histological diagnosis of non-Hodgkin B-cell lymphoma (NHL) [diagnostic criteria according to WHO2008], including diffuse large B-cell lymphoma (DLBCL) non-specific, primary mediastinal large B-cell lymphoma (PMBCL) , Mantle cell lymphoma (MCL), transformed follicles Cell lymphoma (TFL) and other indolent B-cell NHL transformants;
- CD19 positive (immunohistochemistry or flow cytometry);
- DLBCL refractory (refractory) or relapse is defined as: complete remission is not achieved after 2-line treatment; disease appears during any treatment Disease progression, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation;
- MCL: Complete remission has not been achieved after 2-line treatment (including BTK inhibitors); disease progression during any treatment, or disease stable time equal to or less than 6 months; or within 12 months after autologous hematopoietic stem cell transplantation Disease progression or recurrence;
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- There is at least one measurable superficial lesion, and any long diameter of the lymph node lesion is greater than 1.5 cm or any long diameter of the extranodal lesion is greater than 1.0 cm, and the PET-CT scan lesion is ingested (SUV is greater than the liver blood pool);
- Peripheral blood neutrophil absolute value ≥ 2000/mm3, platelet ≥ 50,000/mm3;
- Heart, liver and kidney functions: creatinine <1.5mg/dL; ALT (alanine aminotransferase) / AST (aspartate aminotransferase) below 2.5 times the upper limit of normal; total bilirubin <1.5mg/dL; cardiac ejection fraction ( EF) ≥50%;
- Have sufficient understanding and voluntarily sign the informed consent form;
- Women with fertility must undergo a negative serum pregnancy test and agree to implement effective birth control measures during the treatment phase and within 60 days after the last application of the oncolytic virus;
- Male patients must agree to implement effective birth control measures during the study period and within 60 days after the last viral treatment.
Who cannot join
- There is a history of other tumors;
- Inoculate vaccinia vaccine 3 months before the study treatment and during the study treatment period;
- Have received gene therapy or any type of oncolytic virus therapy within 3 months before the study treatment;
- Other open wounds;
- Active autoimmune diseases;
- Active infection that cannot be controlled;
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- HIV infection, uncontrolled HBV, HCV, and syphilis infection;
- Known lymphoma of the central nervous system;
- Clinically important heart disease;
- Allergic to albumin or egg products;
- Have undergone similar operations such as organ transplantation;
- Systemic treatment of skin diseases is required;
- A history of severe systemic reactions or side effects after vaccinia vaccine injection;
- Known dependence on alcohol or viruses;
- Pregnant or lactating female patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Wenbin Qian, M.D.,PhD., +8613605801032, qianwb@zju.edu.cn
About this study
Official title: Exploratory Study of a Novel Oncolytic Vaccinia Virus Expressing Bispecific Antibody in the Treatment of Refractory/Relapsed B-cell Lymphoma
This is a dose-escalation, single-arm, single-center open study which aims to evaluate the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of a novel oncolytic vaccinia virus expressing bispecific antibody RGV004 in patients with relapsed/refractory B-cell lymphoma,
Read the detailed description
Oncolytic vaccinia virus administered by intratumoral injection
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Being tested
- RGV004
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGV004Biological
a genetically-engineered vaccinia virus (encoding CD19/CD3 bispecific antibody)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Subjects will be treated with RGV004 as a single injection, one time. Receives: Biological: RGV004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the Max tolerated dose (MTD) of RGV004
According to the principle of '3+3' dose escalation, if one patient experiences a Dose limiting Toxicity (DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose (MTD)
Measured: Up to 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate the number of Grade III and above side effects assessed by CTCAE v5.0 for patients who received intratumoral administration of RGV004 injection in patients with R/R B-cell lymphoma.
Measured: Up to 2 years
Secondary outcomes (4)
Objective remission rate (ORR)
The percentage of participants who achieved complete remission (CR) and partial remission (PR) over all participants
Measured: Up to 2 years
RGV004 viral DNA in blood
Viral DNA load will be summarized by cohort
Measured: Up to 2 years
RGV004 viral shedding in saliva
Viral DNA will be analyzed by qPCR
Measured: Up to 2 years
RGV004 viral shedding in urine
Viral DNA will be analyzed by qPCR
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 posted14 May 2021
- Study start8 Feb 2022
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Rongu Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Wenbin Qian, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887025
- Sponsor's protocol ID
- IR2021002042
- Status last verified
- Feb 2023
- First submitted
- 6 May 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of a Novel Oncolytic Vaccinia Virus Expressing Bispecific Antibody in the Treatment of Refractory/Relapsed B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04887025
- Acronym / sponsor ID
- IR2021002042
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hangzhou Rongu Biotechnology Co., Ltd.
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 14 May 2021 (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.
This is a dose-escalation, single-arm, single-center open study which aims to evaluate the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of a novel oncolytic vaccinia virus expressing bispecific antibody RGV004 in patients with relapsed/refractory B-cell lymphoma,
Detailed description
Oncolytic vaccinia virus administered by intratumoral injection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: RGV004Subjects will be treated with RGV004 as a single injection, one time. |
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, the upper limit is 75 years old, there is no restriction on men and women;
- ECOG score 0-1;
- Histological diagnosis of non-Hodgkin B-cell lymphoma (NHL) [diagnostic criteria according to WHO2008], including diffuse large B-cell lymphoma (DLBCL) non-specific, primary mediastinal large B-cell lymphoma (PMBCL) , Mantle cell lymphoma (MCL), transformed follicles Cell lymphoma (TFL) and other indolent B-cell NHL transformants;
- CD19 positive (immunohistochemistry or flow cytometry);
- DLBCL refractory (refractory) or relapse is defined as: complete remission is not achieved after 2-line treatment; disease appears during any treatment Disease progression, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation;
Key exclusion criteria (15 listed)
- There is a history of other tumors;
- Inoculate vaccinia vaccine 3 months before the study treatment and during the study treatment period;
- Have received 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 |
|---|---|---|
| RGV004a genetically-engineered vaccinia virus (encoding CD19/CD3 bispecific antibody) | Biological | Dose Escalation |
Primary outcome
To define the Max tolerated dose (MTD) of RGV004
Time frame: Up to 28 days
According to the principle of '3+3' dose escalation, if one patient experiences a Dose limiting Toxicity (DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose (MTD)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 2 years
To evaluate the number of Grade III and above side effects assessed by CTCAE v5.0 for patients who received intratumoral administration of RGV004 injection in patients with R/R B-cell lymphoma.
4 secondary outcomes
Objective remission rate (ORR)
Time frame: Up to 2 years
RGV004 viral DNA in blood
Time frame: Up to 2 years
RGV004 viral shedding in saliva
Time frame: Up to 2 years
RGV004 viral shedding in urine
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- 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. This study is not recruiting at the moment.
Wenbin Qian principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University
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 RGV004 in people with Relapsed or Refractory 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: status not confirmed, as of the sponsor's last update on 6 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Qian (+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?
To define the Max tolerated dose (MTD) of RGV004 (time frame: Up to 28 days). The study lists 2 primary outcomes in all. 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 6 Feb 2023.