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

RecruitingPhase 1, Phase 2

Sponsor: Vironexis Biotherapeutics Inc.

Conditions: B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma

Interventions: Dose Level 1, VNX-101, Dose Level 2, VNX-101, Dose Level 3, VNX-101, Dose Level 4, VNX-101

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 13 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 and pulmonary function
* Protocol-specified ranges for hematology parameters

Exclusion Criteria:

* 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.

Locations (11)

Duarte, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Rochester, Minnesota, United States
Valhalla, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Houston, Texas, United States