What are cD19-positive leukemias And lymphomas?

The SENTRY-CD19 study is evaluating a potential new treatment for CD19-positive leukemia and lymphoma. CD19-positive leukemias and lymphomas are cancers that have a protein called CD19 on the surface of their cells. CD19-positive cancers include:

Acute Lymphoblastic Leukemia (ALL)
Mixed Phenotype Acute Leukemia (MPAL)
Large B-cell Lymphoma (LBCL)
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Marginal Zone Lymphoma (MZL)
Follicular Lymphoma (FL)
Mantle Cell Lymphoma (MCL)
Diffuse Large B-Cell Lymphoma (DLBCL)
High Grade B-Cell Lymphoma (HGBL)
Burkitt’s Lymphoma (BL)
Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Other types of CD19-positive leukemia and lymphoma may also be included.

Can I Participate?

You may be eligible to participate in this study if you:

Are between the ages of 18 and 90

Have been diagnosed with one of the following types of leukemia or lymphoma:

Mixed Phenotype Acute Leukemia (MPAL)
Acute Lymphoblastic Leukemia (ALL)
Large B-Cell Lymphoma (LBCL)
Chronic Lymphocytic Leukemia (CLL)
Marginal Zone Lymphoma (MZL)
Small Lymphocytic Lymphoma (SLL)
Follicular Lymphoma (FL)
Mantle Cell Lymphoma (MCL)
Diffuse Large B-Cell Lymphoma (DLBCL)
High Grade B-Cell Lymphoma (HGBL)
Burkitt’s Lymphoma (BL)
Non-Hodgkin’s Lymphoma
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
If you have a different type of leukemia or lymphoma not listed here, you can still apply!
Other eligibility criteria apply and will be evaluated by PatientWing and possibly a study doctor/study staff if you choose to continue with screening for the study.
No insurance is needed for study-related procedures or treatments.
check your eligibility

What is the Purpose of the
SENTRY-CD19 Study?

The purpose of the SENTRY-CD19 study is to evaluate a one-time investigational gene therapy called VNX-101. This treatment is designed to help your immune system recognize and destroy cancer cells with a marker called CD19. It may improve outcomes for people whose leukemia or lymphoma has come back or hasn't responded to other treatments.

I’m Interested

Learn More About Gene Therapy

Gene therapy is a treatment approach to help treat or potentially cure a disease. The study drug being tested in this clinical study is VNX-101, an investigational gene therapy.

This gene therapy works by delivering genetic instructions to the liver, prompting it to produce a protein called GP101. This protein helps the immune system identify and destroy cancer cells with a marker called CD19. The therapy is administered as a single IV (intravenous) infusion, aiming to provide a sustained immune response against cancer.

VNX-101 combines the best attributes of CAR-T therapy and blinatumomab (current standard-of-care therapies) into one product, as an off-the-shelf, single-dose therapy with a long-lasting effect.

Why Should I Join the SENTRY-CD19 Study?

By enrolling in this study, you may receive:

Access to expert physicians with experience managing leukemia and lymphoma.
Reimbursements for study participation related expenses, including reasonable costs for travel, meals and lodging, for you and a caregiver.
The investigational study drug at no cost to you.
Insurance is not required for study-specific procedures or treatments.

What Should I Expect?

STEP 1
Submit Online Questionnaire

This questionnaire will ask for your contact information and a few questions about your medical history to determine your pre-qualification. Then, select a time for a short phone call with PatientWing. PatientWing is partnering with Vironexis (study sponsor) to help identify potential individuals who may be interested in the SENTRY-CD19 study. Submitting the questionnaire is voluntary and does not require a commitment to participate in the study.

STEP 2
Speak With PatientWing

You will have a short call with PatientWing to answer additional questions about your medical history and determine whether you may be potentially eligible. If appropriate, PatientWing will help collect your medical records.

STEP 3
Speak With a Research Site

If you are potentially eligible after your conversation with PatientWing, you may meet the research team at the nearest study site, who will review your medical records. If the research team thinks you are a good fit, they will schedule a screening visit. The research team will provide more information during your conversations with them. No question is a bad question so please share your concerns with the team!

STEP 4
Study Participation

After you've completed the screening period, the research team will notify you about your eligibility. If you are enrolled in the study, you should expect the following:

  • You will receive an intravenous (through your vein) or oral (by mouth) dose of a corticosteroid twice a day from about 7 days to 1 day before receiving VNX-101 and every day for 14 days after receiving it.
  • You will receive the one-time infusion of VNX-101. You will also be required to stay one or two nights in the hospital or clinic for observation after receiving this one-time infusion.
  • After receiving the study medication, you will be asked to visit your study doctor weekly for the first 56 days for observation.
  • There will be approximately 28 visits for the first 5 years and then yearly phone call follow-ups, or in person visits if your study doctor requests this, for years 6-15. The study doctor/study staff will provide you with more information about the follow-up period during your screening visit appointment.

Frequently Asked Questions

How do I get started?

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Click here to fill out the pre-screen questionnaire and express interest in the study. You can also email studies@patientwing.com or call 213-459-2979.

Is there any cost for me to participate?

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There is no cost to participate in this clinical study. The study sponsor will pay for the costs of the study drug and any study-required tests or procedures. You may discuss travel arrangements and expense-related reimbursements with the research site staff.

Can I leave the study at any time?

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You’re free to withdraw from the study at any time before receiving the study drug, as study participation is completely voluntary. Withdrawal will not be used against you nor affect your standard medical care in any way. However, the investigational medication is a single infusion, therefore, once administration is complete, it is not possible to reverse it. The safety visits are an important part of monitoring your health after receiving the investigational medication, but if you wish to withdraw after the infusion has started, you should discuss this with your study doctor. Please contact the study doctor so that they can safely withdraw your participation in the study.

How long is the study?

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This study lasts for a total of 15 years. It includes approximately 28 visits to your study site for the first 5 years. Each visit will take approximately 1-2 hours. Then, from years 6 to 15, you’ll have yearly phone call follow-ups, unless your study doctor requests an in-person visit.

Is there a chance I will receive a placebo?

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No, this is an open-label study, so you will not receive a placebo. If you are eligible and choose to enroll, you will receive the study drug, VNX-101.

Why didn’t I qualify?

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An answer you provided was outside the guidelines for participating in this study. This does not mean you will not qualify for other or future research studies. Depending on the reason you didn’t qualify, you may have another opportunity to be considered for the study.

Are you a healthcare provider wanting to learn more?

click here to learn more

About the Study Team

About the Sponsor

Vironexis Biotherapeutics is working to change the way cancer is treated by developing a new kind of gene therapy that helps the immune system fight cancer. Their approach uses gene therapy to deliver treatment with just one dose — no need for complex or repeated procedures. This new method is designed to be easier, faster, and longer-lasting than many current cancer therapies.

About PatientWing

Our mission to bring treatments to more people faster starts with you. We help sponsors find patients to participate in their clinical studies. With our focus on rare and serious conditions and expertise in navigating the enrollment process, we're here for you every step of the way.

Have Questions?

At PatientWing, we’re here to support you. You can email, text, call or fill out the form with any questions. We’re here to help.
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