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

Recruiting Phase 1 Phase 2 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
13 – 90
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
Vironexis Biotherapeutics Inc. · Industry
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About This Trial

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 Locations
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Eligibility Criteria
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 an…
Contacts

Allen Reha

908-938-6019

allen.reha@vironexis.com

CONTACT

Recruitment Partner: PatientWing

213-459-2979

studies@patientwing.com

CONTACT