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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
ClinicalTrials.gov ID: NCT06533579
What this study is testing
What is Dose Level 1, VNX-101?
Dose Level 1, VNX-101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 90
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Valhalla, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; Valhalla, New York, United States; Chapel Hill, North Carolina, United States; Columbus, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.