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

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.

Trial Details

NCT ID
NCT06533579
Phase
PHASE1 / PHASE2
Sponsor
Vironexis Biotherapeutics Inc.
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Dose Level 1, VNX-101
  • Dose Level 2, VNX-101
  • Dose Level 3, VNX-101
  • Dose Level 4, VNX-101
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Denver, Colorado, United States|39.73915,-104.9847
  • Valhalla, New York, United States|41.07482,-73.77513
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key 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

For full eligibility, visit ClinicalTrials.gov.

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