Relapsed or refractory leukemia or lymphoma Clinical Study

The SENTRY-CD19 Study

The purpose of the SENTRY-CD19 study is to evaluate an investigational gene therapy called VNX-101. This treatment is delivered as a one-time infusion and designed to help the 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.

Participants must meet the following criteria:

Are between the ages of 18 and 90
Have relapsed or refractory CD19-positive B-cell leukemia or lymphoma, including one of the following conditions:

Acute Lymphoblastic Leukemia (ALL)
Mixed Phenotype Acute Leukemia (MPAL)
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Follicular Lymphoma (FL)
Marginal Zone Lymphoma (MZL)
Mantle Cell Lymphoma (MCL)

Patients with other types of relapsed or refractory CD19-positive B-cell leukemia or lymphoma may also be qualified.
Adequate liver, kidney, lung, and heart function
No history of adverse reaction to corticosteroids
No history of thrombotic microangiopathy or hemolytic uremic syndrome
Willing to commit to effective contraception throughout the 5-year study from time of consent

Participants are not eligible if they:

Have an infection or any other severe systemic disease, medical, surgical, or other condition that could adversely affect the safety of the patient
Have taken any unlicensed or investigational product within 30 days prior to VNX-101 dosing
Are pregnant or nursing (lactating) women
Have active hepatitis B or C (tested within 3 months of screening or during screening), or any uncontrolled infection at screening
Have a HIV positive test within 3 months of screening or during screening
Received biologic agents with immunosuppressive activity within 14 days prior to VNX-101 dosing
Have had an allogeneic hematopoietic stem cell transplantation within 3 months of VNX-101 dosing
Have acute GvHD Grade 2-4 or chronic GvHD of any grade
Have received a vaccination with attenuated live virus within 2 months of expected VNX-101 dosing

Other eligibility criteria apply and will be evaluated by a principal investigator.

This is an open-label study, so there is no chance of placebo.

Participants will be expected to:

Visit the research site to receive the one-time infusion of the study medication. Participants may be required to stay in a clinic or hospital for seven nights after receiving the infusion for observation.
After receiving the study medication, they will visit the research site weekly for the first 56 days (approximately 8 visits).
They will then be followed up with monthly, every 2 months, every 4 months, and every 6 months for the first 4 years, followed by yearly check-ins for 5 to 15 years. This may include phone call follow-ups from the study doctor during years 6-15.

What the SENTRY-CD19 Study Offers

By enrolling in this study, patients may receive:

Access to expert healthcare providers with experience managing leukemia and lymphoma.

Reimbursements for study participation related expenses, including reasonable costs for travel, meals and lodging, for the patient and a caregiver.

The investigational study drug at no cost.

Unlike most cancer treatments that require repeated cycles of chemotherapy or custom-made cell therapies, the VNX-101 study is testing a single-dose gene therapy designed to help the body continuously fight CD19-positive cancer cells over time, without the need for repeated treatments.

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

Get Started

Preliminary Clinical Findings

Preliminary clinical activity has been observed with investigational VNX-101 in the ongoing Phase 1/2 SENTRY-CD19 study.

Among evaluable patients with relapsed/refractory ALL who were antibody-negative at baseline, three patients achieved clonoSEQ-confirmed MRD-negative complete responses in the bone marrow following a single administration of VNX-101.

One of these patients had extensive extramedullary disease at baseline and also achieved a complete response at all PET-evaluable extramedullary disease sites by Day 28.

These findings are preliminary, are based on a small number of patients, and require further evaluation. VNX-101 is investigational, and its safety and efficacy have not been established.

Read the full press release

Next Steps

If you have a patient who might be interested and potentially eligible for this study — or if someone comes to mind — you can:

Complete the Contact PatientWing form below. We’ll contact you and discuss how your patient can get involved.

Share this study directly with your patient so they can apply on their own. Provide them with this website so they can read about the study and fill out a pre-screen questionnaire.

If you have patients who may be a good fit for the study or you are interested in being an investigator (working on this study), please contact PatientWing (using the form below)!

Contact PatientWing

If you have a patient who may be eligible, we would love to speak with you! Please submit the information below so our team can reach out. There is no obligation to you or your patient, by submitting this form.

studies@patientwing.com

213-459-2979

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