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Frequently asked questions
Cell therapy is a treatment approach that uses healthy cells to repair or replace cells that have been damaged by certain diseases. These cells may come from either the person being treated (called autologous) or from a donor (called allogeneic). In both cases, blood is taken and the needed cells are extracted. The type of cells used depends on the condition being treated. These cells may then be modified or processed and then infused into the person being treated.
TREGZI is a precision-engineered cell therapy with both stem cell and T cells from a matched donor for transplant to help improve survival without GVHD in adults with blood cancers.
TREGZI is a precisely designed therapy for transplant that contains both donor (allogeneic) stem cells and T cells.
- The donor stem cells contained in TREGZI are meant to grow and divide into the healthy blood and immune cells your body needs
- The T cells in TREGZI help rebuild your immune system so that it is better able to fight the cancer, while reducing the risk of cGVHD
Each of the different types of cells in TREGZI is delivered back into your body at a set time. This allows your immune system to rebuild and can reduce the risk of complications such as cGVHD.
Both TREGZI and traditional allogeneic stem cell transplant replace cancer cells with healthy ones and offer the chance for a cure. Yet there are important differences with TREGZI that can impact the overall treatment experience.
TREGZI is a precisely designed allogeneic stem and T cell therapy that balances 2 different types of T cells. Each of the different types of cells in TREGZI is delivered into your body at a set time. This helps your blood and immune system to rebuild and can reduce the risk of complications such as cGVHD.
With TREGZI, 3 different types of cells will be precisely and intentionally selected from your donor cells and prepared for your transplant.
You will receive:
- Hematopoietic stem and progenitor cells (HSPCs), which are the “starter cells” that grow into the different types of blood cells your body needs, including red blood cells, white blood cells, and platelets
You’ll also receive 2 types of T cells:
- Regulatory T cells (Tregs) that lower (suppress) the powerful immune response started by the body’s Tcons once the infected or cancerous cells have been eliminated
- Conventional T cells (Tcons) that seek out the cancer cells and direct a robust immune response to eliminate them
TREGZI uses cells from a matched donor. A defined set of 3 types of cells are selected and processed in a special facility and handled with the utmost of care.
In the clinical trial, Precision-T, TREGZI + tacrolimus was shown to give people a greater chance of survival without moderate-to-severe cGVHD and lower risk of severe infection compared with traditional allogeneic stem cell transplant + tacrolimus and methotrexate.
The goal is to administer your first TREGZI infusion bag within 72 hours or less from the time the cells were collected.
At 1 year, about 94% of people who received TREGZI + tacrolimus were alive compared with about 83% of people who received traditional allogeneic stem cell transplant + tacrolimus and methotrexate. The difference between the 2 treatment groups was not statistically meaningful.
Survival results are descriptive and should not be interpreted as definitive evidence.
While TREGZI has been designed to help lower the risk of certain complications of allogeneic stem cell transplant, not all side effects can be avoided and there is still a chance to experience unwanted reactions to treatment.
In clinical trials, the most common side effects were inflammation of the digestive tract, diarrhea, rash, viral infections, infections from an unknown pathogen, abdominal pain, vomiting, nausea, bacterial infections, bleeding, acute graft-versus-host disease (aGVHD), swelling and fungal infections.
There are a number of steps involved with TREGZI. The process includes finding a suitable donor and preparing your new cells, preparing for the infusion, getting your TREGZI infusion, and being monitored after the transplant.
Take a closer look at the steps involved.
Following transplant, the new cells will travel through your bloodstream to your bone marrow, where they will begin to make new cells. This is called engraftment. The first signs of engraftment will be an increase in the number of white blood cells and platelets circulating in your system. It takes about 2-4 weeks after transplant for this to happen.
Visit MyTREGZI to learn about available support and resources.
