Afamitresgene Autoleucel

TECELRA is a genetically modified autologous T cell immunotherapy consisting of CD4 and CD8 positive T cells transduced with a self-inactivating LV to express an affinity- enhanced TCR specific for human MAGE-A4 on the cell surface. The TCR recognizes an HLA-A*02 restricted MAGE-A4 peptide.

• TECELRA is a melanoma-associated antigen A4-(MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies ( 14 )].ICD-10: C43.9

• DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA- A*02:05P. DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA-A*02:05P ( 4 ).contraindicated

For autologous use only. For intravenous use only. For autologous use only. For intravenous use only. Prior to infusion Verify patient's identity prior to infusion ( 2.2 ). Administer a lymphodepleting regimen of cyclophosphamide and fludarabine ( 2.2 ). Premedicate with acetaminophen and an H1-antihistamine ( 2.2 ). TECELRA Dose and Administration The recommended dose is between 2.68 x 10 9 to 10 x 10 9 MAGE-A4 T cell receptor (TCR) positive T cells ( 2.1 ). Administer each infusion bag within one hour of thawing. DO NOT USE a leukodepleting filter ( 2.2 ). DO NOT USE prophylactic systemic corticosteroids ( 2.2 ). 2.1 Recommended Dose The recommended dose is between 2.68 x 10 9 to 10 x 10 9 MAGE-A4 T cell receptor (TCR) positive T cells administered as a single intravenous infusion. TECELRA is provided as a single dose for infusion in one or more infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation for infusion. 2.2 Preparation and Administration Receipt of TECELRA Plan for TECELRA to arrive prior to beginning lymphodepleting chemotherapy. Ensure storage conditions in vapor phase of liquid nitrogen (≤ -130°C). TECELRA is shipped directly to the healthcare facility in the vapor phase of a liquid nitrogen shipper. Upon receipt of TECELRA confirm the patient's identifiers on the metal cassette and product bag. Inspect the product for obvious signs of damage and contact 1-855-246-9232 if any anomalies are identified at the time of receipt.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) : Monitor for ICANS events for at least 4 weeks after treatment with TECELRA ( 5.2 ). Prolonged Severe Cytopenia : Patients may exhibit severe cytopenia (hemoglobin < 8.0 g/dL, neutrophils < 1,000/mm 3 , platelets < 50,000/mm 3 ) for several weeks following lymphodepleting chemotherapy and TECELRA infusion. Monitor blood counts prior to and after TECELRA infusion ( 5.3 ). Infections : Monitor patients for signs and symptoms of infection; treat appropriately ( 5.4 ). Secondary Malignancies : In the event that a secondary malignancy occurs after treatment with TECELRA, contact 1-855-246-9232 ( 5.5 ). Hypersensitivity Reactions : Monitor for hypersensitivity reactions during infusion ( 5.6 ). Effects on Ability to Drive and Use Machines : Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 4 weeks after receiving TECELRA ( 5.2 ). 5.1 Cytokine Release Syndrome Cytokine release syndrome (CRS), including potentially life-threatening reaction has been observed following administration of TECELRA. CRS occurred in 75% of patients, 2% of whom had Grade ≥ 3 CRS. The median time to onset was 2 days (range: 1 to 5 days) and the median time to resolution was 3 days (range: 1 to 14 days). The most common symptoms were fever (97%), tachycardia (52%), hypotension (30%), nausea/vomiting (21%) and headache (15%) [see Adverse Reactions ( 6 )] . Management for CRS (including Grade 1) was tocilizumab (55%).

Most common adverse reactions (≥ 20%) were, cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema. Grade 3 or 4 laboratory abnormalities (≥20%) were lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased ( 6.1 ). The most common serious adverse reactions (≥ 5%) were cytokine release syndrome and pleural effusion ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact USWM CT, LLC at 1-855-246-9232 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects the exposure to TECELRA in 44 patients with advanced synovial sarcoma treated in the SPEARHEAD-1 clinical trial (Cohort 1). Patients with synovial sarcoma received TECELRA across a dose of 2.68 x 10 9 to 10 x 10 9 MAGE-A4 TCR positive T cells [see Clinical Studies ( 14 )]. Serious adverse reactions occurred in 52% of patients with synovial sarcoma. The most common serious adverse reactions (occurring in ≥ 5%) included CRS (9%) and pleural effusion (7%). Table 1 summarizes adverse reactions that occurred in at least 10% of patients. Table 1.

8.1 Pregnancy Risk Summary There are no available data with TECELRA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with TECELRA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if TECELRA has the potential to be transferred to the fetus and cause fetal toxicity. Therefore, TECELRA is not recommended for women who are pregnant, and pregnancy after TECELRA administration should be discussed with the treating physician. Report all pregnancies following treatment with TECELRA to 1-855-246-9232. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of TECELRA in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TECELRA and any potential adverse effects on the breastfed infant from TECELRA or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status of females with reproductive potential prior to starting treatment with TECELRA.

Metabolism

TECELRA exhibited an initial engraftment and expansion phase followed by contraction, and then persistence. High inter-individual variability was observed.

1. 1Acute Myeloid Leukaemia233%
2. 2Cytokine Release Syndrome233%
3. 3Pyrexia233%
4. 4Dyspnoea117%
5. 5Fatigue117%
6. 6Hallucination117%
7. 7Pain117%
8. 8Product Packaging Issue117%
9. 9Rash117%
10. 10Urticaria117%

The 3 most recently updated of 3 ClinicalTrials.gov registrations naming Afamitresgene Autoleucel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• SPEARHEAD-3 Pediatric Study
  Recruiting · Phase 1 · Phase 2 · Interventional · 20 enrolled · USWM CT, LLC
  NCT05642455updated 2026-02-09
• Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
  Available · Expanded access · USWM CT, LLC
  NCT06617572updated 2026-02-09
• Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
  Active not recruiting · Phase 2 · Interventional · 52 enrolled · USWM CT, LLC
  NCT04044768updated 2026-02-06

Frequently asked questions

How does Afamitresgene Autoleucel work?

TECELRA is a genetically modified autologous T cell immunotherapy consisting of CD4 and CD8 positive T cells transduced with a self-inactivating LV to express an affinity- enhanced TCR specific for human MAGE-A4 on the cell surface. The TCR recognizes an HLA-A*02 restricted MAGE-A4 peptide.

What is Afamitresgene Autoleucel used for?

According to FDA labeling, Afamitresgene Autoleucel carries indications including: TECELRA is a melanoma-associated antigen A4-(MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies ( 14 )].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Afamitresgene Autoleucel?

Afamitresgene Autoleucel is classified as Cellular Proliferation Alteration.

What are the brand names for Afamitresgene Autoleucel?

Afamitresgene Autoleucel is marketed under brand names including Tecelra.

What are the contraindications for Afamitresgene Autoleucel?

Afamitresgene Autoleucel labeling lists contraindications including: DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA- A*02:05P. DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA-A*02:05P ( 4 ).. Always consult the full prescribing information and a clinician.