Tecelra

Tecelra (afamitresgene autoleucel) is a T cell immunotherapy used to treat synovial sarcoma (SyS), a rare cancer of the soft tissue that cannot be removed with surgery (unresectable) or that has spread to other parts of the body (metastatic). It is used in patients 12 years of age and older who have already received chemotherapy. To be eligible, patients must also have a specific HLA type, and their cancer cells must carry a protein called MAGE-A4.

Tecelra is a one-time personalized infusion that uses your own immune cells, which have been trained to recognize and attack synovial sarcoma cells that display the melanoma-associated antigen A4 (MAGE-A4) protein on a specific HLA-A*02 marker.

Before you can receive Tecelra, testing must confirm two things: that you carry a qualifying HLA type (one of HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P) and that your tumor makes the MAGE-A4 protein. Both are checked using an FDA-approved or cleared companion diagnostic test.

Tecelra's drug class is genetically modified autologous T cell immunotherapy. It is a type of T cell receptor (TCR) T cell therapy. Afamitresgene autoleucel is also known as afami-cel.

Tecelra is given as a one-time infusion into a vein.

Tecelra was granted accelerated approval on August 2, 2024, and this was converted to a traditional approval on June 17, 2026, which also expanded the indication to include patients 12 years of age and older. Tecelra is made by US WorldMeds (USWM CT, LLC).

Tecelra is an FDA-approved treatment for adults and children 12 years of age and older who have synovial sarcoma that cannot be removed with surgery (unresectable) or that has spread to other parts of the body (metastatic), and who have already received chemotherapy.

To be able to receive Tecelra, a person must meet all of the following:

• Be an adult, or a child 12 years of age or older
• Have synovial sarcoma that is unresectable or metastatic
• Have already received prior chemotherapy
• Carry a qualifying HLA type (HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P)
• Have a tumor that makes the MAGE-A4 protein, confirmed by an FDA-approved or cleared companion diagnostic test

Tecelra is made from your own T cells and is given as a single infusion. The overall process involves several steps handled by your healthcare team:

• Collecting your cells. Your T cells are collected from your blood through a procedure called leukapheresis.
• Making the treatment. Your cells are sent to a manufacturing facility, where they are genetically modified and grown into larger numbers, then frozen and shipped back to your treatment center. There is about a 7% chance of a manufacturing or shipping failure, in which case a second attempt may be made.
• Preparing your body (lymphodepletion). A short course of chemotherapy with cyclophosphamide and fludarabine is given in the days before your infusion to make room for the modified cells.
• Premedication. You will receive an antihistamine and acetaminophen about 30 to 60 minutes before the infusion. Preventive steroids are avoided because they may interfere with how Tecelra works.
• The infusion. Tecelra is given as a single infusion into a vein.

After treatment, you will be monitored daily at the healthcare facility for at least 7 days for signs of CRS and nervous system effects, and you will need to stay within reach of the facility for at least 2 weeks.

Tecelra has a Boxed Warning, the FDA's most serious type of warning, for cytokine release syndrome (CRS).

CRS is a reaction that can occur when the treatment activates your immune system. It can be severe or life-threatening. CRS occurred in most people who received Tecelra in clinical trials. Symptoms may include fever, fast heartbeat, low blood pressure, lightheadedness or dizziness, shortness of breath, nausea or vomiting, diarrhea, and headache.

At the first sign of CRS, your healthcare team will check whether you need to be hospitalized and will start supportive treatment. Tecelra is given in a setting where healthcare providers have immediate access to medicines and emergency equipment to manage CRS.

Tecelra should not be used in people who carry the HLA-A*02:05P type in one or both copies of the gene (heterozygous or homozygous). This is the only contraindication listed in the prescribing information.

In addition, Tecelra should not be given to people who have an active infection or inflammatory disorder at the time of treatment.

Your healthcare team will do several checks before you receive Tecelra:

• HLA typing and MAGE-A4 testing to confirm you are eligible.
• Screening for infections. You may be tested for viruses such as Epstein-Barr virus, cytomegalovirus, hepatitis B, hepatitis C, and HIV. Antiviral treatment may be considered to prevent a virus from reactivating.
• A pregnancy test if you are able to become pregnant.

Tell your healthcare provider about all your medical conditions, including if you have an active infection, and if you are pregnant, plan to become pregnant, or are breastfeeding.

Pregnancy

There is only limited information on the use of Tecelra in pregnant women, and it is not known whether it can harm an unborn baby. Tecelra is not recommended during pregnancy. Discuss pregnancy after treatment with your treating physician, and report any pregnancy following treatment to 1-855-246-9232.

Breastfeeding

It is not known whether Tecelra passes into breast milk or how it may affect a breastfed baby. Talk with your healthcare provider about the best way to feed your baby.

Tecelra may cause serious side effects, including:

• Cytokine release syndrome (CRS). See the boxed warning above. CRS and infections were the most common serious side effects.
• Nervous system problems (ICANS). Immune effector cell-associated neurotoxicity syndrome (ICANS) can occur. Symptoms may include confusion, trouble speaking, drowsiness, disorientation, and, in severe cases, seizures. You will be monitored for at least 2 weeks after treatment.
• Prolonged low blood cell counts (cytopenia). Low red blood cells, white blood cells, and platelets can last for several weeks after treatment. Signs may include tiredness, shortness of breath, bruising or bleeding, and fever. Your blood counts will be checked before and after infusion.
• Infections. Serious infections can occur, and past infections can become active again. Tell your healthcare provider about any signs of infection, such as fever.
• Secondary cancers. People treated with Tecelra may develop a new cancer or a return of their cancer, and will be monitored for this.
• Allergic (hypersensitivity) reactions. Serious allergic reactions, including anaphylaxis, may occur during the infusion because of an ingredient called dimethyl sulfoxide (DMSO).
• False-positive HIV test results. Tecelra is made using a viral vector that shares short pieces of genetic material with HIV. Because of this, some HIV tests may show a false-positive result after treatment.
• Effects on driving and using machines. Because of the risk of nervous system effects such as dizziness, you should not drive or operate heavy or dangerous machinery for at least 2 weeks after treatment.

The most common side effects of Tecelra are cytokine release syndrome (CRS), nausea, tiredness, muscle and bone pain, infections, and fever. Many people also have vomiting, constipation, diarrhea, headache, cough, or swelling.

The most common side effects (reported in 20% or more of people) include:

• cytokine release syndrome (CRS)
• nausea and vomiting
• tiredness (fatigue)
• muscle and bone pain (musculoskeletal pain)
• infections
• fever (pyrexia)
• constipation and diarrhea
• headache
• cough
• fast heartbeat (tachycardia)
• swelling (edema)
• shortness of breath (dyspnea)
• rash

Common laboratory changes included decreases in lymphocytes, white blood cells, neutrophils, and red blood cells.

These are not all the possible side effects of Tecelra. You can report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or to USWM CT, LLC at 1-855-246-9232.

The recommended dose is between 1.62 x 10⁹ and 10 x 10⁹ MAGE-A4 T cell receptor (TCR) positive T cells, given as a single infusion into a vein. The dose is contained in one or more infusion bags and is prepared for you individually. Because Tecelra is a one-time treatment, there is no missed-dose or repeat-dose schedule.

Tecelra works by teaching your own T cells (a type of white blood cell that helps your immune system find and destroy threats) to recognize and attack synovial sarcoma cells.

Your T cells are collected and genetically modified to carry a special receptor (a T cell receptor, or TCR) that is designed to find the MAGE-A4 protein. For the modified cells to recognize a tumor cell, the MAGE-A4 protein must be displayed on the surface of that cell by a molecule called HLA-A*02. This is why you are tested for both your HLA type and MAGE-A4 before treatment. When the receptor locks onto MAGE-A4 presented on HLA-A*02, the T cells switch on, multiply, and kill the synovial sarcoma cells.

In its main clinical trial, about 44% of people who received Tecelra had their tumors shrink, and responses lasted a median of 5.3 months. Tecelra does not work for everyone, and results vary from person to person.

The effectiveness of Tecelra was studied in a clinical trial called SPEARHEAD-1 (NCT04044768), which included 137 people with advanced synovial sarcoma who received a single infusion. The main measure was how many people had their tumors shrink after treatment (overall response rate).

• About 44% of people who received Tecelra had their tumors shrink. This included a small group whose cancer was no longer detectable (complete response, about 4%) and a larger group whose tumors shrank significantly (partial response, about 40%).
• Responses lasted a median of 5.3 months, meaning half of the people who responded had a response lasting longer than this and half shorter. Some responses were much longer, lasting more than 5 years in a few people.
• Among the people who responded, about 48% still had a response at 6 months and about 32% at 12 months.
• When a response occurred, it tended to happen quickly, at a median of about 4.6 weeks after treatment.

No drug interactions are listed in the prescribing information. Tell your healthcare provider about all the medicines you take, since some medicines, such as steroids, may be avoided around the time of treatment.

Tecelra is stored and handled by your healthcare facility, not at home. It is kept frozen in the vapor phase of liquid nitrogen at or below -130 degrees C until it is thawed and given to you.

Active component: genetically modified autologous T cells that express a MAGE-A4-directed T cell receptor.

Other component: the frozen cell suspension contains 5% dimethyl sulfoxide (DMSO).

Tecelra is manufactured by USWM CT, LLC (US WorldMeds), 351 Rouse Boulevard, Philadelphia, PA 19112. U.S. License Number 2416.

Is Tecelra a one-time treatment?

Yes. Tecelra is given as a single infusion into a vein. There is no repeat or maintenance schedule.

Is Tecelra a CAR-T therapy?

No. Tecelra is a TCR T cell therapy, not a CAR-T therapy. Both use a patient's own modified T cells, but Tecelra uses an engineered T cell receptor (TCR) that recognizes the MAGE-A4 protein inside the cancer cell, while CAR-T therapies target proteins on the cell surface.

Can Tecelra be used to treat melanoma?

No. Although the target protein is called MAGE-A4 (melanoma-associated antigen A4), Tecelra is approved only for synovial sarcoma. The name reflects where the protein was first identified, not the cancer Tecelra treats.

Is Tecelra used in children?

Yes, in part. Tecelra is approved for children 12 years of age and older, as well as adults. It has not been shown to be safe or effective in children younger than 12.

Can Tecelra cause a false-positive HIV test?

Yes. The viral vector used to make Tecelra shares short pieces of genetic material with HIV, so some HIV tests may give a false-positive result after treatment. Let your healthcare provider know you have received Tecelra.

Why does my HLA type matter?

The modified T cells can only recognize the MAGE-A4 protein when it is presented on a specific molecule called HLA-A*02. Only people with a qualifying HLA-A*02 type can benefit, and people with the HLA-A*02:05P type should not receive Tecelra.