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Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06533579.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Approved
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
VNX-101 is an investigational adeno-associated virus (AAV) gene therapy developed to
express a secreted anti-CD19/anti-CD3 scFv diabody (termed GP101). GP101 binds both
cluster of differentiation (CD)19 and CD3, inducing T-cells to kill both benign and
malignant B-cells. Following a single intravenous (IV) infusion, the vector induces the
liver and key tissues to continuously secrete GP101 into the bloodstream, resulting in
long-term, consistent serum levels of GP101. Potential advantages of VNX-101 over
autologous CAR-T therapy include it is off-the-shelf, provides a gentle onset of action,
does not require lymphodepletion chemotherapy, engages all T-cells continuously
(including those freshly produced from the bone marrow), and utilizes highly efficient
signaling through the native T-cell receptor.
In this 2-part study, dose-finding data from Part 1 of the study (n=~12 patients) will be
used determine the dose for Part 2 in patients. Part 1 is a dose-finding PK study in
adults ≥18 years old designed to determine the minimal dose that achieves target PK serum
levels of GP101 at steady state (8-week timepoint) without dose-limited toxicities,
defined as the recommended Part 2 dose (RP2D). Prior to VNX-101 dosing, subjects may
undergo standard of care chemotherapy to meet dosing criteria. Part 2 (n=~20) will be
opened following data safety monitoring board review of Part 1 data and is designed to
determine the safety and pharmacokinetics (PK) of VNX-101 at the RP2D in a broader array
of subjects. The age range for Part 2 will be expanded to include subjects ≥13 years old.
Patients will be followed for safety and efficacy up to 5 years post VNX-101 dosing.
Long-term follow-up assessments for safety will be conducted for 6 to 15 years post
