Learn about biomarker testing to see if you could be eligible for TECELRA
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What will the journey look like for me or my loved one?

TECELRA is a personalized, one-time therapy that is different from other synovial sarcoma treatments

Dosing for TECELRA is unique—after pre-treatment, it takes a single infusion of your own engineered T cells to target and destroy synovial sarcoma cells in your body. Learn more about each step of the treatment journey below.

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1

Biomarker testing for eligibility

This is how your medical team will determine if you are able to receive TECELRA. You will need:

  • A blood test to determine if you express a specific genetic marker—an HLA protein on your cells
  • A tumor tissue test to check for the biomarker called MAGE-A4, which is the protein TECELRA is designed to target on tumor cells
Find out more about these tests.
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2

T-cell collection

Your T cells are collected from your blood through a process called leukapheresis. They are then frozen and shipped to the manufacturing facility to create your personalized treatment.

TIME: Up to 8 hours

LOCATION: TECELRA Authorized Treatment Center (ATC)

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Cell manufacturing

Next, your T cells are thawed and engineered to create TECELRA. This is done through a genetic process that changes your T cells so they target tumor cells in your body.

Your modified T cells are checked for quality and then frozen.

TIME: About 6 weeks (time may vary)

LOCATION: US WorldMeds’ specialized manufacturing facility

After passing a quality check, your frozen engineered T cells are transported back to the ATC where you will receive treatment.

Your ATC stores these frozen engineered T cells that make up TECELRA until it is time for your TECELRA infusion.

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4

Pre-treatment lymphodepleting chemotherapy

Before receiving TECELRA, you will undergo lymphodepletion, which is a short-course pre-treatment chemotherapy regimen that lasts 4 days. This is different than a normal course of chemotherapy used to treat cancer, as lymphodepletion is intended only to prepare your body to receive your engineered T cells. This 4-day regimen will start 7 days before your TECELRA infusion.

TIME: 4 days

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Administration of TECELRA

When it's time to receive your uniquely engineered TECELRA, your treatment team will thaw your stored T cells and administer premedication. This will consist of an antihistamine and acetaminophen 30 minutes to 1 hour before your infusion to help prevent reactions. Then you will receive your TECELRA infusion, which can come in 1 or more infusion bags and may take up to 1 hour per bag.

TIME: Up to 1 hour for 1 infusion bag + premedication time

TECELRA is administered by a dedicated treatment team. Talk to your doctor to learn how you can get access to TECELRA.

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6

Monitoring after infusion

After your TECELRA infusion, your care team will check to see that your treatment is working and help you with any side effects that may occur. TECELRA may cause side effects that can be severe or life-threatening. To learn more about these side effects, explore Possible Serious Side Effects.

After infusion, you will be monitored daily for at least 7 days at the healthcare facility where you received your treatment. You should remain close to a healthcare facility for at least 2 weeks following your infusion.

See Important Safety Information, including Important Warning, below.

TIME: At least 2 weeks

Not actual patients.

HLA=human leukocyte antigen; MAGE=melanoma-associated antigen.

Positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, -A*02:06P, and negative for HLA-A*02:05P.

A dose of TECELRA may be contained in 1 or more infusion bag(s). A healthcare provider will determine the number of bags needed for your dose of TECELRA before preparing your infusion.

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See how TECELRA works

INDICATION and IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION
and INDICATION

What is TECELRA?

TECELRA® is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you.

IMPORTANT SAFETY INFORMATION

Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

INDICATION and IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY
INFORMATION and INDICATION

What is TECELRA?

TECELRA® is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you.

IMPORTANT SAFETY INFORMATION

Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 2 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 2 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, fatigue, musculoskeletal pain, infection, fever (100.4°F/38°C or higher), constipation, vomiting, headache, diarrhea, cough, fast heart rate, swelling, shortness of breath, rash, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, decreased red blood cell count, and decreased platelet count.

You are encouraged to report side effects to the FDA at (800) FDA‑1088 or www.fda.gov/medwatch or to US WorldMeds at 1-855-246-9232.

What is TECELRA?

TECELRA® is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you.

Please see Medication Guide, including Important Warning.

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