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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.

Read more about TREGZI

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

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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.

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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.

Take a closer look at the clinical trial

The goal is to administer your first TREGZI infusion bag within 72 hours or less from the time the cells were collected.

Get to know more about TREGZI

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.

Take a closer look at the clinical trial

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.

See possible side effects

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.

IMPORTANT SAFETY INFORMATION AND INDICATION

ISI tray

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INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

IMPORTANT SAFETY INFORMATION

Before you receive TREGZI, tell your healthcare provider about all your medical conditions, including if you have:

  • Lung or breathing problems
  • Heart problems
  • Liver problems
  • Kidney problems
  • A recent or active infection

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TREGZI can cause serious side effects, including:

  • Graft Failure. Failure to rebuild the blood and/or immune system, which may be fatal, can occur after receiving TREGZI. Your healthcare provider will monitor you closely after TREGZI administration.

  • Graft-Versus-Host Disease (GVHD). Immune reactions from the donor’s cells may occur soon (days) or long (months) after receiving TREGZI. Tell your healthcare provider right away about any signs and symptoms including rash, joint pain, diarrhea, or yellowing of the eyes.
  • Infusion Reactions. Infusion reactions can occur after TREGZI infusion. Tell your healthcare provider right away about any signs and symptoms including fever, chills, flushing, fatigue, shortness of breath, and dizziness/lightheadedness.
  • Secondary Cancer and Cancer from Donor Cells. New cancers can develop after treatment with TREGZI. If you are diagnosed with a new cancer after treatment, contact Orca Bio at 1-877-290-6722.
  • Transfer of Serious Infections. Transfer of serious infectious diseases can occur because TREGZI is made from the human blood cells of a donor. Transfer may occur even though donors are screened and tested for infectious diseases.

The most common side effects of TREGZI include 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.

These are not all the possible side effects of TREGZI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

Please see accompanying full Prescribing Information including Patient Information.