Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)

Launched by VIRONEXIS BIOTHERAPEUTICS INC. · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VNX-101 for patients with a type of blood cancer known as B-cell acute lymphoblastic leukemia (ALL) that has not responded to previous therapies or has come back after treatment. This is an early-stage trial, meaning it’s the first time this treatment is being tested in humans to see if it is safe and effective. The trial is currently looking for participants aged 13 to 90 who have specific types of B-cell ALL, particularly those who have either relapsed or are not responding to other treatments like CAR-T therapy.

If you or a loved one is interested in participating, you would need to meet certain criteria, such as having a certain level of cancer cells in your bone marrow and not having any serious liver issues or other specific health complications. Participants can expect to receive VNX-101 and will be closely monitored by the research team to ensure their safety and to see how well the treatment is working. This trial is an important step in exploring new options for patients with tough-to-treat leukemia, and your involvement could help advance our understanding of this disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age
• • Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol
• • CD19-positive expression
• • AAV specified capsid total antibody \<1:400
• • Protocol-specified ranges for renal, liver, cardiac and pulmonary function
• • Protocol-specified ranges for hematology parameters
• Exclusion Criteria:
• • Hepatoxicity (AST or ALT \> 2x upper limit of normal)
• • History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
• • Pregnant or nursing (lactating) women
• • Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade
• • History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity
• • Chemotherapy given within the protocol-specified discontinuation timelines
• • Other Inclusion/Exclusion criteria to be applied per protocol.