Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
Recruiting now · Phase 1/Phase 2
Conditions studied: B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Burkitt Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Non Hodgkin Lymphoma, Mixed Phenotype Acute Leukemia
In brief
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.
Key facts
- Study ID
- NCT06533579
- Run by
- Vironexis Biotherapeutics Inc.
- People needed
- 32
- Starts
- 2025-05-30
- Expected to finish
- 2031-09-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 13 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- Protocol-specified ranges for hematology parameters
You may not qualify 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.
Where it is running
- City of Hope — Duarte, California, United States (enrolling)
- Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
- Mayo Clinic, Clinical Trials Referral Office — Jacksonville, Florida, United States (enrolling)
- Mayo Clinic, Clinical Trials Referral Office — Rochester, Minnesota, United States (enrolling)
- New York Medical College — Valhalla, New York, United States (enrolling)
- University of North Carolina at Chapel Hill/ University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (enrolling)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- TriStar BMT — Nashville, Tennessee, United States (enrolling)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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