Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) is a cell therapy given as part of an allogeneic (donor) stem cell transplant to treat blood cancers. Like other cancer treatments, Tregzi can cause side effects. Some are common and expected, while others can be serious and need prompt medical care.
Because Tregzi is given during a stem cell transplant, you will be cared for very closely by your transplant team — often in the hospital for part of your treatment. Your team will watch for side effects and treat them as they come up. Many of the effects described here come from the transplant as a whole, including the strong conditioning treatment (chemotherapy, sometimes with radiation) that is given before Tregzi.
Keep reading to learn about the possible side effects of Tregzi, ways to help prevent or manage them, and when to contact your health care provider.
This article does not include every possible side effect of Tregzi. Tell your health care provider about any new or worsening symptoms during or after treatment, even if they are not listed here.
Common Tregzi Side Effects
The following side effects were commonly reported (in at least 20% of people) in the clinical study of Tregzi:
- Mouth and throat soreness (mucositis)
- Diarrhea
- Rash
- Infections
- Stomach pain
- Nausea and vomiting
- Bleeding
- Swelling (edema)
Low blood cell counts, including low white blood cells, red blood cells, and platelets, are also expected as your new blood-forming cells rebuild your bone marrow. Your team will check your blood counts often, and they may give you transfusions or other supportive care while your counts recover.
In most cases, these side effects are temporary and often improve on their own. However, contact your health care provider if you experience symptoms that feel severe. Do not stop taking Tregzi unless your provider recommends it.
Serious Side Effects of Tregzi
Some side effects of Tregzi can be serious. Your transplant team will monitor you closely for these and treat them as needed. Less common but potentially serious side effects of Tregzi include:
- Graft failure (when the transplanted cells do not take hold)
- Graft versus host disease (GvHD)
- Infusion reactions
- New cancers, including cancers that may come from the donor’s cells
- Transmission of an infection from the donated cells
- Allergic reactions
If you think you may be having a serious side effect, contact your health care team right away. Some symptoms can become severe quickly and may need urgent attention. Your team can evaluate your symptoms and explain what steps to take next.
Tips for Managing Tregzi Side Effects
Some side effects can be managed with simple strategies. The sections below explain common Tregzi side effects and what you can do to help prevent or relieve them.
Mouth and throat soreness
Mouth and throat soreness, called mucositis, was the most common side effect in the Tregzi study. It was reported in about 85% of people. Symptoms may include redness, swelling, soreness, or sores in the mouth or throat that can make it hard to eat, drink, or swallow. Much of this comes from the strong conditioning treatment given before transplant.
These steps may help protect your mouth:
- Brush gently with a soft toothbrush, and keep your mouth clean, following your team’s mouth-care instructions.
- Choose soft, cool, bland foods, such as smoothies or yogurt. A straw may help.
- Avoid spicy, acidic, dry, or rough foods, as well as alcohol and tobacco.
- Sip fluids throughout the day to keep your mouth moist.
Your care team can prescribe mouth rinses and pain relief and will help treat more severe mucositis. Tell them if your mouth soreness makes it hard for you to eat or drink.
Diarrhea and stomach pain
Diarrhea was common in the Tregzi study. It was reported in about 69% of people, and abdominal pain was reported in about 45%. Symptoms may include loose or watery stools, belly cramps, and an urgent need to use the bathroom.
To help manage mild diarrhea:
- Drink fluids (such as water, broth, or electrolyte drinks) often to prevent dehydration.
- Eat bland foods, such as rice, bananas, or applesauce.
- Limit greasy, spicy, or high-fiber foods. Avoid caffeine and alcohol.
Tell your care team about diarrhea and belly pain rather than treating it on your own. Diarrhea can sometimes be a sign of GvHD or an infection, so your team will want to check the cause before recommending any antidiarrheal medicine.
Nausea and vomiting
In the Tregzi study, nausea was reported in about 41% of people and vomiting in about 44%. These are common with transplant and its conditioning treatment.
These tips may help manage them:
- Eat smaller meals more often instead of large meals.
- Choose bland, easy-to-digest foods, and avoid greasy or strong-smelling foods.
- Sip clear fluids through the day to stay hydrated.
Your care team can give you anti-nausea medicines. Tell them if nausea or vomiting is severe, does not improve, or makes it hard to keep down food, drinks, or medicines.
Infections
Infections are common after transplant because your immune system is weakened while it rebuilds. In the Tregzi study, viral infections occurred in about 51% of people, bacterial infections in about 40%, and fungal infections in about 20%.
To lower your risk, your team will take steps such as preventive medicines and careful monitoring. Following these things may help protect you from infections:
- Wash your hands often, and ask visitors to do the same.
- Avoid close contact with people who are sick.
- Follow all instructions about preventive medicines, food safety, and activity.
Contact your care team right away if you have a fever or other signs of infection, such as chills, cough, or new pain. Infections after transplant can become serious quickly and often need prompt treatment.
Skin rash
Rash was reported in about 65% of people in the Tregzi study. To help care for your skin, keep it moisturized with a gentle, fragrance-free product, avoid harsh or irritating skin products, and protect your skin from too much sun.
Tell your care team about any new or worsening rash. A rash after transplant can be a sign of GvHD, so your team will want to examine it and decide on treatment.
Low blood counts and tiredness
Low blood cell counts are expected after transplant while your new cells rebuild your bone marrow. Low red blood cell counts (anemia) can cause tiredness, and low platelet counts can raise the risk of bleeding or bruising, which was reported in about 39% of people in the study.
Your care team will check your blood counts often and may give transfusions or other supportive care. To help with tiredness:
- Rest when you need to, and plan activities for times when you have the most energy.
- Eat regular meals or snacks, and drink enough fluids.
- Try light activity, such as short walks, if your care team says it is safe.
Tell your care team about any unusual bleeding or bruising or if tiredness becomes severe.
Graft versus host disease (GvHD)
GvHD happens when the donor’s immune cells see your body’s healthy tissues as foreign and attack them. Tregzi is designed to lower the risk of chronic GvHD, and you will also receive a medicine called a calcineurin inhibitor to help prevent it. Even so, GvHD can still occur.
In the Tregzi study, acute GvHD occurred in about 38% of people. Moderate-to-severe chronic GvHD developed in about 13% of people treated with Tregzi, compared with about 41% of people who received a standard donor graft.
GvHD can affect the skin (rash), the gut (diarrhea, belly pain, nausea), the liver (yellowing of the skin or eyes), and other parts of the body. It can range from mild to life-threatening, and it is treated with medicines that calm the immune system. Report any new rash, diarrhea, belly pain, or yellowing of your skin or eyes to your care team right away so it can be treated early.
Reducing Your Risk of Tregzi Side Effects
You can help lower your risk of some side effects and catch problems early by working closely with your transplant team. Make sure that you:
- Take all preventive medicines exactly as prescribed, including the medicine given to help prevent GvHD.
- Go to all of your appointments and blood tests so your team can monitor you.
- Follow instructions about mouth care, hand washing, food safety, and avoiding infection.
- Keep track of new or changing symptoms, and tell your team about them.
- Tell your team about all other medicines, vitamins, and supplements you take.
- Do not stop or change any medicine on your own. Contact your health care provider if you have side effects that do not improve or if they get worse or interfere with your daily life.
Your health care provider can help you decide whether changes to your treatment plan are needed.