Gene therapy for certain blood cancers
A Phase 1/2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)
This study is testing a new gene therapy called VNX-101 to see if it can help people with certain types of blood cancers that haven't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 13 Years to 90 Years |
| Sex | All |
| Sponsor | Vironexis Biotherapeutics Inc. Industry-sponsored |
| Drugs / interventions | Chemotherapy, CAR-T |
| Locations | 9 sites (Duarte, California and 8 other locations) |
| Trial ID | NCT06533579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 or adolescents aged 13-90 with relapsed or refractory CD19-positive leukemia or lymphoma.
Not a fit: Patients with significant liver toxicity, certain heart conditions, or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat blood cancers.
How similar studies have performed: Other studies have shown promise with similar gene therapy approaches, indicating potential for success in this novel treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Duarte, California and 8 other locations
- 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)
- New York Medical College — Valhalla, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill/ University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- TriStar BMT — Nashville, Tennessee, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Allen Reha
- Email: allen.reha@vironexis.com
- Phone: 908-938-6019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.