# Afamitresgene autoleucel

Source: https://onco.cc/drugs/afamitresgene-autoleucel/  
OnCo record `afamitresgene-autoleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Afamitresgene autoleucel was the first engineered T-cell receptor therapy approved for a solid tumour, synovial sarcoma.

## Summary

Afamitresgene autoleucel (afami-cel) is a TCR-T therapy: patient T cells are engineered with an affinity-enhanced T-cell receptor that recognises the MAGE-A4 230-239 peptide on HLA-A*02, so eligibility requires both HLA typing and tumour MAGE-A4 testing. It received accelerated approval in August 2024 for advanced MAGE-A4-positive, HLA-A*02-positive synovial sarcoma on SPEARHEAD-1 (ORR about 39%, median duration of response about 12 months), and in Q2 2026 the label was extended to patients aged 12 and over. Treatment is a single infusion of 2.68 to 10 x 10^9 TCR-positive cells after fludarabine and cyclophosphamide; cytokine release syndrome and prolonged cytopenias are the main risks. Whether responses are durable enough to change survival is open. For a newcomer: the first engineered T-cell receptor therapy approved for a solid tumour.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Tecelra
- Code: afami-cel
- Modality: TCR-T (MAGE-A4)
- Mechanism: Affinity-enhanced TCR against MAGE-A4 230-239/HLA-A*02.
- Approvals: US 2024: Advanced MAGE-A4+ synovial sarcoma, HLA-A*02+ (age ≥12 from 2026)
- Dosing: Single IV infusion after lymphodepletion; 2.68 × 10⁹ to 10 × 10⁹ MAGE-A4 TCR+ T cells; fludarabine 30 mg/m² ×4 and cyclophosphamide 600 mg/m² ×3

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Afamitresgene_autoleucel
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Afamitresgene%20autoleucel

## Connected records

- biomarkers: [HLA-A*02:01 (HLA typing for TCR therapies)](https://onco.cc/biomarkers/hla-a-02-01/)
- cancers: [Sarcomas (soft tissue, bone, GIST)](https://onco.cc/cancers/sarcoma/), [Synovial sarcoma](https://onco.cc/cancers/synovial-sarcoma/)
- technologies: [TCR-T cell therapy](https://onco.cc/technologies/tcr-t/)
- targets: [HLA-A](https://onco.cc/targets/hla-a/), [MAGE-A4](https://onco.cc/targets/mage-a4/)
- companies: [Adaptimmune](https://onco.cc/companies/adaptimmune/), [US WorldMeds](https://onco.cc/companies/us-worldmeds/)
- trials: [Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma](https://onco.cc/trials/nct04044768/), [SPEARHEAD-3 Pediatric Study](https://onco.cc/trials/nct05642455/)
- key papers: [SPEARHEAD-1: afamitresgene autoleucel, the first engineered T-cell receptor therapy approved for a solid tumour, in synovial sarcoma](https://onco.cc/key-papers/paper-spearhead-1-lancet-2024/)
- terms: [HLA-A*02:01 restriction](https://onco.cc/terms/hla-a02-restriction/), [SS18::SSX fusion (synovial sarcoma)](https://onco.cc/terms/ss18-ssx-fusion/)
- ideas: [Extending sarcoma TCR-T beyond HLA-A*02](https://onco.cc/ideas/idea-tcr-t-beyond-hla-a2/)
- roadmaps: [Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR](https://onco.cc/roadmaps/cell-therapy-roadmap/)
- people: [Sandra P. D'Angelo](https://onco.cc/people/sandra-dangelo/)
- institutions: [Comprehensive Cancer Center Tübingen-Stuttgart](https://onco.cc/institutions/ccc-tuebingen/)

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