Gene Therapy for B-Cell Acute Lymphoblastic Leukemia
Sponsor: Vironexis Biotherapeutics Inc.
ClinicalTrials ID:NCT06533579
This clinical trial is testing a new gene therapy called VNX-101 to see if it is safe and effective for patients with B-cell acute lymphoblastic leukemia (ALL) that has returned or not responded to treatment. The study is in two parts and involves patients aged 13 and older.
Patient Parameters
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Program Overview
The study is exploring a new gene therapy, VNX-101, for treating B-cell acute lymphoblastic leukemia (ALL) that has come back or is not responding to other treatments. VNX-101 uses a virus to deliver a special protein that helps the body's immune cells target and destroy cancerous B-cells. This therapy is given through a single IV infusion and is designed to provide long-term treatment without the need for additional chemotherapy. The trial is divided into two parts: the first part will determine the best dose for patients with a lower amount of cancer cells, and the second part will test this dose in patients with a higher amount of cancer cells. Participants will be monitored for safety and effectiveness for up to 5 years after receiving the treatment.
Description
VNX-101 is a new type of gene therapy that uses a virus to deliver a protein called GP101 into the body. This protein helps the immune system's T-cells find and kill cancerous B-cells. The therapy is designed to be a long-term treatment option that doesn't require additional chemotherapy. The study is divided into two parts. In Part 1, researchers will find the best dose of VNX-101 for patients with a lower amount of cancer cells. In Part 2, this dose will be tested in patients with a higher amount of cancer cells. Participants will be followed for up to 5 years to see how well the treatment works and to monitor for any side effects. The study will also include long-term safety checks for up to 15 years after treatment.
Eligibility Criteria
Inclusion Criteria
- Age: Part 1: 18-90 years old, Part 2: 13-90 years old
- Have B-cell ALL that has returned or not responded to treatment, with a certain level of cancer cells in the bone marrow
- Not eligible for, or have declined, CAR-T therapy, or have not responded to or relapsed after such therapy
- If previously treated with blinatumomab, cancer cells must still have the CD19 marker and not be resistant to blinatumomab
- Meet specific health criteria for kidney, liver, heart, and lung function
- Meet specific blood test criteria
Exclusion Criteria
- Liver problems with certain enzyme levels more than twice the normal limit
- History of certain blood vessel or heart conditions, or nerve damage
- Pregnant or breastfeeding women
- Have certain grades of Graft versus Host Disease (GvHD)
- History of severe reactions to steroids or related side effects
- Recent chemotherapy within specific timeframes set by the study
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| Oncology Hematology Care | 45242 | Cincinnati | Ohio |
| The Ohio State University Wexner Medical Center | 43210 | Columbus | Ohio |
| TriStar BMT | 37203 | Nashville | Tennessee |
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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