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

Part of paid clinical trials in Duarte, California.

Sponsor
Vironexis Biotherapeutics Inc.
Study ID
NCT06533579
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • Burkitt Lymphoma
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • High-grade B-cell Lymphoma
  • Large B-cell Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Mixed Phenotype Acute Leukemia
  • Non Hodgkin Lymphoma
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
13 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Dose Level 1, VNX-101 — GENETIC
    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
  • Dose Level 2, VNX-101 — GENETIC
    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
  • Dose Level 3, VNX-101 — GENETIC
    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
  • Dose Level 4, VNX-101 — GENETIC
    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

Study Details

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 Dates

Start date
May 30, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2031

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1/Group 2/Group 3/Group 4

Primary Outcome Measure

Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs) [ Time Frame: Change from Baseline to Year 5 post dosing ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Anthony Stein, MD
[email protected]
877-467-3411
Anthony Stein, MD (PRINCIPAL_INVESTIGATOR)
Valkyrie Clinical TrialsLos AngelesCalifornia90067
Myo Zaw
[email protected]
424-535-1874
Colorado Blood Cancer InstituteDenverColorado80218
Clinical Trial Information Line
720-754-4835
New York Medical CollegeValhallaNew York10595
Mitchell Cairo, MD
[email protected]
914-594-2150
Lauren Harrison
[email protected]
Mitchell Cairo, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel Hill/ University of North Carolina Medical CenterChapel HillNorth Carolina27599
Lacey Williams, MD
[email protected]
919-445-9676
The Ohio State University Wexner Medical CenterColumbusOhio43210
Gregory Behbehani, MD, PhD
[email protected]
614-293-3316
Oregon Health & Science UniversityPortlandOregon97239
Knight Cancer Institute Clinical Trials
[email protected]
503-949-1080
TriStar BMTNashvilleTennessee37203
Stephen Strickland, MD
[email protected]
615-329-7274
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Nicholas J Short, MD
[email protected]
713-563-4485

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City of Hope· Duarte, CAValkyrie Clinical Trials· Los Angeles, CAColorado Blood Cancer Institute· Denver, CONew York Medical College· Valhalla, NYUniversity of North Carolina at Chapel Hill/ University of North Carolina Medical Center· Chapel Hill, NCThe Ohio State University Wexner Medical Center· Columbus, OH

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