NCT06533579RecruitingPhase 1/2
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
A Phase 1/2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 24 Jul 2024
- Start date
- 30 May 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Vironexis Biotherapeutics Inc.
- Diseases
- Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma, Follicular lymphoma, Mantle cell lymphoma, Chronic lymphocytic leukaemia, Childhood cancers
- NCT number
- NCT06533579
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 32
- From 30 May 2025 to the primary completion date, Jun 2027
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chemotherapy given within the protocol-specified discontinuation timelines
- Other Inclusion/Exclusion criteria to be applied per protocol.
Other illness
- History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
- 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
Lab values
- Hepatoxicity (AST or ALT \> 2x upper limit of normal)
Other
- Pregnant or nursing (lactating) women
Who the study is looking for
- 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 per protocol requirement
- Protocol-specified ranges for renal, liver, cardiac and pulmonary function
- Protocol-specified ranges for hematology parameters
Age in the registry: 13 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill/ University of North Carolina Medical Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Mayo Clinic, Clinical Trials Referral Office Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Valkyrie Clinical Trials Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| TriStar BMT Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Mayo Clinic, Clinical Trials Referral Office Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.