Trial reportLancet (London, England)2024
Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial.
Trial report in Lancet (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 206 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Who cites it
206 citing papers in PubMed, 2 syntheses or guidelines pooled it, 227 citations in OpenAlex.
- Global Panoramic analysis of clinical research in cell therapy: clinical trial landscape, marketed products, and regulatory trends.Frontiers in pharmacology · 2026Pooled it
- Indications for haematopoietic cell transplantation and CAR-T for haematological diseases, solid tumours and immune disorders: 2025 EBMT practice recommendations.Bone marrow transplantation · 2025Guideline
- Phase 1/2 study of IMC-C103C, a T cell receptor bispecific (MAGE-A4×CD3) ImmTAC targeting MAGE-A4-expressing malignancies.Journal for immunotherapy of cancer · 2026Trial
- Letetresgene Autoleucel in Advanced/Metastatic Myxoid/Round Cell Liposarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Monocyte-lineage tumor infiltration predicts immunoradiotherapy response in advanced pretreated soft-tissue sarcoma: phase 2 trial results.Signal transduction and targeted therapy · 2025Trial
- The evolution of cellular therapies in sarcoma: Breakthroughs, challenges, and future directions.Human vaccines & immunotherapeutics · 2026Review
- The promise of immunotherapy in the treatment of sarcoma: A state-of-the-art review of practice changing research and future directions.Human vaccines & immunotherapeutics · 2026Review
- Primary synovial sarcoma of the thyroid mimicking medullary thyroid cancer.JCEM case reports · 2026Article
- Cellular immunotherapy for lung cancer: current clinical evidence, translational challenges, and future perspectives: a narrative review.Translational cancer research · 2026Article
- Review
- Simultaneous gene engineering of T cells with multiple neoantigen-specific T cell receptors for adoptive cell transfer.Molecular therapy. Advances · 2026Article
- Real-world experience with ipilimumab in combination with nivolumab in advanced sarcoma: a retrospective analysis including ultra-rare sarcomas.The oncologist · 2026Article
- Chimeric antigen receptor (CAR)-T cell therapy for solid tumors in pediatric patients: current breakthroughs, dilemmas, and strategies.Experimental hematology & oncology · 2026Review
- Salvage Metastasectomy After Adoptive Cell Transfer for Melanoma: Long-Term Updates.Annals of surgical oncology · 2026Article
- Adoptive cell therapy in lung cancer: progress, challenges, and prospects.Chinese medical journal pulmonary and critical care medicine · 2026Review
- Cell-based cancer immunotherapy: milestones, mechanistic insights, and emerging therapeutic directions.Acta pharmacologica Sinica · 2026Review
- T Cell Thoughts.Immunological reviews · 2026Review
- MAGEA Family Gene Expression Influences Survival in Intestinal-Type Gastric Cancer.Cancer medicine · 2026Article
- Review
- Technical review of artificial intelligence in TCR-T therapy.Journal of the National Cancer Center · 2026Review
146 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
43 authors at 20 institutions in 5 countries.
Funding
Abstract
backgroundAfamitresgene autoleucel (afami-cel) showed acceptable safety and promising efficacy in a phase 1 trial (NCT03132922). The aim of this study was to further evaluate the efficacy of afami-cel for the treatment of patients with HLA-A*02 and MAGE-A4-expressing advanced synovial sarcoma or myxoid round cell liposarcoma.
methodsSPEARHEAD-1 was an open-label, non-randomised, phase 2 trial done across 23 sites in Canada, the USA, and Europe. The trial included three cohorts, of which the main investigational cohort (cohort 1) is reported here. Cohort 1 included patients with HLA-A*02, aged 16-75 years, with metastatic or unresectable synovial sarcoma or myxoid round cell liposarcoma (confirmed by cytogenetics) expressing MAGE-A4, and who had received at least one previous line of anthracycline-containing or ifosfamide-containing chemotherapy. Patients received a single intravenous dose of afami-cel (transduced dose range 1·0 × 10
findingsBetween Dec 17, 2019, and July 27, 2021, 52 patients with cytogenetically confirmed synovial sarcoma (n=44) and myxoid round cell liposarcoma (n=8) were enrolled and received afami-cel in cohort 1. Patients were heavily pre-treated (median three [IQR two to four] previous lines of systemic therapy). Median follow-up time was 32·6 months (IQR 29·4-36·1). Overall response rate was 37% (19 of 52; 95% CI 24-51) overall, 39% (17 of 44; 24-55) for patients with synovial sarcoma, and 25% (two of eight; 3-65) for patients with myxoid round cell liposarcoma. Cytokine release syndrome occurred in 37 (71%) of 52 of patients (one grade 3 event). Cytopenias were the most common grade 3 or worse adverse events (lymphopenia in 50 [96%], neutropenia 44 [85%], leukopenia 42 [81%] of 52 patients). No treatment-related deaths occurred.
interpretationAfami-cel treatment resulted in durable responses in heavily pre-treated patients with HLA-A*02 and MAGE-A4-expressing synovial sarcoma. This study shows that T-cell receptor therapy can be used to effectively target solid tumours and provides rationale to expand this approach to other solid malignancies.
fundingAdaptimmune.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.