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

Plain-language summary

This Phase 1/2, first-in-human, open-label dose-escalation trial assesses the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies. Part 1 enrolls patients aged 18 to 90 years and Part 2 enrolls patients aged 13 to 90 years. Eligibility requires confirmed CD19-positive expression, an AAV capsid total antibody titer below 1:400, and renal, liver and cardiac values within protocol-specified ranges.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Recruiting

Sponsor

Vironexis Biotherapeutics Inc.

Intervention

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

Start date

5/30/2025

Estimated completion

9/1/2031

Countries

United States

Locations

• Duarte, United States
• Los Angeles, United States
• Denver, United States
• Jacksonville, United States
• Rochester, United States
• Valhalla, United States
• Chapel Hill, United States
• Columbus, United States
• Portland, United States
• Nashville, United States
• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.