Gene therapy for certain blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 trial evaluates the safety and efficacy of VNX-101, a gene therapy designed to treat relapsed or refractory CD19-positive hematologic malignancies. The therapy uses an adeno-associated virus to deliver a diabody that targets both CD19 and CD3, activating T-cells to eliminate malignant B-cells. The study consists of two parts: the first part focuses on determining the appropriate dosing, while the second part assesses the safety and pharmacokinetics of the recommended dose. Participants may receive standard chemotherapy prior to treatment to meet dosing criteria.

Why it matters

Who can join: the full rules

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 per protocol requirement
* 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.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Mayo Clinic, Clinical Trials Referral Office
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic, Clinical Trials Referral Office
  Rochester, Minnesota, United States Recruiting
• New York Medical College
  Valhalla, New York, United States Recruiting

Study contacts

• Study coordinator: Allen Reha
• Email: allen.reha@vironexis.com
• Phone: 908-938-6019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.